Positive Predictive Value of Digital Ankle Brachial Index (ABI) as a Screening Tool in Detecting Peripheral Arterial Disease: A Single Center, Prospective Clinical Trial
Phase: NA
Conditions: Peripheral Artery Disease, Amputation, Smoking, Diabetes, Hypercholesterolemia, Hypertension
Sponsor: St. Louis University

 
 
 
                       PROTOCOL 
Biomedical Research 
Saint Louis University 
Protocol # 28225 
Date Printed: 08/02/2018 
 
 
 
Continuing Review   
1 
 
Personnel Information   
6 
 
Subject Population   
13 
 
Study Location   
13 
 
General Checklist   
14 
 
Funding   
14 
 
Expedited Paragraphs   
15 
 
Background, Purpose, Study Procedures   
17 
 
Radioisotopes or Radiation Machines   
22 
 
Devices   
23 
 
Drugs, Reagents, Chemicals, or Biologic Products   
24 
 
Other Levels Of Review   
24 
 
Subject Population   
26 
 
Subject Population   
27 
 
Risks   
29 
 
Benefits/Alternatives, Procedures to Maintain Confidentiality and Privacy   
32 
 
Potential Conflict of Interest   
36 
 
Informed Consent   
37 
 
Assent   
38 
 
HIPAA   
39 

 
 
 
e-PRCTCCCL.. 
 
PROTOCOL 
Biomedical Research 
Saint Louis University 
Protocol # 28225 
Date Printed: 08/02/2018 
 
 
 
 
Attachments......................................................................................41 
 
 
PI Obligations....................................................................................42 
 
 
Event History .....................................................................................43 

 
1 
 
PROTOCOL 
Biomedical Research 
Saint Louis University 
Protocol # 28225 
Pereira 
 
------------------------------------------------------------------------------ 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a 
screening tool in detecting peripheral arterial disease: A single center, 
prospective clinical trial 
Protocol Status: 
APPROVED 
Date Submitted: 
04/04/2018 
Approval Period: 
04/20/2018-04/19/2019 
Important Note: 
This Print View may not reflect all comments and contingencies for approval. 
Please check the comments section of the online protocol. 
Questions that appear to not have been answered may not have been required 
for this submission. Please see the system application for more details. 
 
 
* * * Continuing Review * * * 
 
Continuing Review Request 
 
WHAT TO UPLOAD WITH YOUR CONTINUING REVIEW APPLICATION 
 
 
For studies where research activities are limited to data analysis, upload subject safety 
information and publications (e.g., manuscripts, abstracts) since the last IRB approval, if 
applicable. 
 
NOTE: if activities are limited to data analysis of de-identified/anonymous data (data that 
can no longer be linked to subject identifiers directly or through use of a code with master 
list kept), the study can likely be closed via the Final Report Form. See the SLU IRB 
Guidance for Closure of Human Subjects Research Studies. 
 
For all other studies, upload: 
•  Subject safety information including the most current Serious Adverse Event 
(SAE) cumulative table and data safety monitoring reports since the last IRB 
approval, if applicable. 
• Any publications (e.g., manuscripts, abstracts) since the last IRB approval. 
 
Any changes, updated and/or new study materials should be uploaded and questions 19 - 
24 of this form should be completed. 
 
 
1. 
Please indicate the status of the study: 
a) 
The study has not started but will become active. 
Please explain why the study has not started. 
 
b) 
X 
The study is ACTIVE (please check the appropriate box below): 
Study is open to accrual. 
X 
Study is on hold or halted. 
Please explain what needs to occur before accrual can resume. 
We targeted recruitment for several months in the summer of 2017, and plan to 
begin again after reconvening the study team and creating and executing the 
workflow again. Nothing else is needed to start accrual again. 
Study is permanently closed to accrual. 
 
 
 
Page 1 of 45 

 
2 
 
PROTOCOL 
Biomedical Research 
Saint Louis University 
Protocol # 28225 
Pereira 
 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
 
 
 
i. 
Have all subjects completed all research related 
activities/interventions? 
ii. 
Will the research only remain active for long-term follow-up of 
subjects? 
iii. 
Are remaining research activities limited to data analysis only? (See 
instructions above). 
iv. 
For studies that are closed to subject accrual, do any subjects need 
to be re-consented (to inform them about changes to study 
procedures, study risks, study personnel, etc.)? 
For IRB office use: * may qualify for expedited review 
c) 
The study has expired and needs to be re-initiated. 
Explain any research activities occurring during lapse in IRB approval. 
 
 
 
2. 
Date the study was initially approved by the IRB: 
04/26/2017 
 
3. 
Approval date of previous continuing review: 
 
 
4. 
Total number of participants/records/specimens you are approved to 
enroll. 
400 
 
 
5. 
Total number of subjects that have given consent (verbal or written) to 
date. 
264 
 
 
6. 
Total number of subjects that failed screening (if not applicable, state 
26 
N/A). 
 
 
7. 
Total number of participants accrued since the beginning of the project. 
238 
 
 
8. 
For multi-center studies, number of subjects approved for accrual study-   NA 
wide (SLU site plus all other sites). 
 
 
9. 
For multi-center studies, number of subjects enrolled study-wide (SLU 
NA 
site plus other sites). 
 
 
10. 
Number of withdrawals from the research and explanation/reasons for withdrawals. 
 
none 
 
 
 
 
Page 2 of 45 

 
3 
 
PROTOCOL 
Biomedical Research 
Saint Louis University 
Protocol # 28225 
Pereira 
 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
 
 
 
11. 
Description and number of: 
 
 
a) 
Reportable Protocol Deviations/Violations since the last approval date: 
4/2/18 Protocol Violation: 26 subjects are unusable since 23 consents we signed by subjects 
after being altered by hand. An additional 3 subjects are unusable since the HIPAA and consent 
signature pages were hand-written. Consents were signed by people who were not approved 
members of the research team. 
 
 
b) 
Unanticipated Problems (UPs) since the last approval date: 
none. 
 
 
c) 
Serious Adverse Events (SAEs) since the last approval date:Note: Information here should be 
consistent with the cumulative table, which should also be attached in section #16. 
none. 
 
12. 
Have there been any complaints about the research during the last year? 
N 
If yes, please describe. 
 
 
13. 
Briefly describe the progress of the study to date. Provide a status of participants in study, for 
example, where is the most recently accrued participant in terms of timeline in the study? If 
participants are in long-term follow-up, explain what this consists of in terms of data collection 
and/or intervention. Provide any new information in regard to risks. Summarize or attach 
publications or presentations. 
All accrued subjects have completed all required study activities. No long-term follow up is needed. 
 
 
14. 
Is there a Data Safety Monitoring (DSM) plan for this study? 
Y 
No 
Yes, a copy of the DSM report(s) for the last approval period is attached. 
Yes, but a copy of the DSM reports(s) for the last approval period is not attached. Please 
explain below. 
 
 
15. 
FDA Regulated Studies 
 
 
Is this a Food and Drug Administration (FDA) Regulated Study, (i.e., involves drugs, 
N 
devices, biologics)? If yes, please answer the following questions: 
 
 
 
a) 
Have there been any changes in the FDA status of any 
drug or device used in the study? 
 
 
 
 
Page 3 of 45 

 
4 
 
PROTOCOL 
Biomedical Research 
Saint Louis University 
Protocol # 28225 
Pereira 
 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
 
 
If yes, please explain: 
 
 
 
b) 
Have any of the investigational drugs or devices used in 
this study received FDA approval? 
If yes, please explain: 
 
 
 
c) 
Have any new alternative drugs or devices been approved 
for treatment of the study condition that may affect subjects 
willingness to participate? 
If yes, please explain: 
 
 
Have current subjects been notified? Please explain: 
 
 
 
d) 
Has there been a change in the standard care that may be 
considered as an alternative to the investigational drug or 
device or that would affect the original study design? 
If yes, please explain: 
 
 
Have current subjects been notified? Please explain: 
 
 
 
e) 
Is there any new information that might affect the 
risk/benefit ratio and the willingness of current study 
subjects to participate or to continue to participate in the 
research? 
If yes, please explain: 
 
 
Have current subjects been notified? Please explain: 
 
 
f) 
Does the study include an investigator's brochure (IB)? 
If yes, what is the current version date? 
 
 
 
(If study has multiple IBs, attach current versions in Attachments 
section (#16)) 
 
 
 
 
 
 
Page 4 of 45 

 
5 
 
PROTOCOL 
Biomedical Research 
Saint Louis University 
Protocol # 28225 
Pereira 
 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
 
 
 
16. 
Provide a summary of any recent findings, literature, or other relevant information (especially 
pertaining to risks), if applicable. 
Of the 238 subjects with usable data, QuantaFlo detected positive results for Peripheral Artery 
Disease in 44 subjects: 10 with severe, 15 with moderate, and 19 with mild disease. Of the 10 
designated severe by QuantaFlo, 8 were confirmed upon follow-up exams and imaging (positive 
predictive value of 67%). Of those 34 designated mild or moderate by QuantaFlo, 2 were 
confirmed upon follow-up exams and imaging (positive predictive value of 14%). 
 
 
17. 
Have there been any significant amendments or revisions to the 
N 
protocol during the past approval period? (Significant amendments 
include changes in study design or risk level including those that 
resulted in a change in consent). 
If yes, please briefly summarize the changes: 
 
 
18. 
Y 
The consent materials attached to this eIRB application (including consent documents, assent
documents, recruitment statements or other materials used to obtain consent) are the 
versions being used in the conduct of this study and all enrolled subjects have signed consent
forms on file, if required. (If the requirement to obtain consent was waived or if no participants
have enrolled since last continuing review, check N/A). 
NOTE: The IRB routinely monitors consent document usage and may request copies of 
redacted participant consent forms. 
 
19. 
Are any changes (amendments) requested with this Continuing Review? 
Y 
Yes, please complete the remainder of this form. 
No, form is complete. Please submit. 
 
20. 
Summarize the proposed changes to the protocol in lay terms, including the type of change AND 
what the change involves. 
 
If this is a change in PI a new  Department Chair review is required. Please upload the signed 
document in the Attachments section. 
We would like to increase the sample size from 400 to 750. This change involves using the same 
protocol on additional subjects by re-instituting the workflow at screening locations. We are also 
adding a study team member, Scott Wilson-Flewelling. 
 
 
21. 
Provide justification/explanation for the proposed changes. 
Given the low PPV of QuantaFlo, and considering the manufacturing company has different 
results, we would like to continue the study and increase enrollment to increase the power of our 
analysis. 
 
 
22. 
Will currently accrued subjects need to be notified of changes? 
N 
If no, please justify why not. 
All subjects who have been accrued have completed all study activities and will not be affected by 
additional subjects being accrued. 
 
 
 
Page 5 of 45 

PROTOCOL 
Protocol # 28225 
Pereira 
Biomedical Research 
Saint Louis University 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
Page 6 of 45 
 
 
6 
 
 
additional subjects being accrued. 
If yes, please explain how AND when notification or re-consenting will occur. 
 
 
23. 
Does the SLU IRB Protocol need to be modified? 
Y 
24. 
Are consent documents modified? 
Y 
 
 
 
 
 
Proceed to the appropriate section(s) of the protocol and make your changes. Also make necessary changes in 
the Consent Form(s), Assent Form(s), Recruitment Statement, Questionnaire, or other attachments, as 
applicable. Upload any revised IRB materials. Please provide the entire revised document (not just revised 
pages). Use track changes or highlight (in yellow) changes to documents being revised. Please upload a 
tracked/highlighted copy of each revised document to be stamped upon IRB approval. NOTE: Upload a clean 
copy (changes or highlights removed) of documents in file formats other than Microsoft Word (i.e., the IRB will 
remove the tracked changes/highlights on uploaded Word documents). 
 
 
NOTE: Protocol amendments must receive IRB review and approval before they are implemented, unless an 
immediate change is necessary to eliminate an apparent hazard to the subjects. 
 
 
Sponsored Studies: Remember to update the Sponsor's Protocol version number and date in the Funding section 
of the protocol (this information will appear on the approval letter). 
 
 
List of changed sections: 
Personnel Information 
Subject Population 8(a-g) 
Informed Consent (13) 
--------------------------------------------------------------------------------------------- 
* * * Personnel Information * * * 
Study Personnel Roles: 
-Principal Investigator: accepts responsibility for study, must sign obligations, can edit protocol and submit to IRB 
-Administrative Contact: additional study contact, may or may not also be member of research team, can 
edit/prepare protocol and submit to IRB 
-Key Personnel (Research Team): SLU member of research team, can view protocol (not edit) 
-Non-SLU Collaborator: member of research team from another institution or organization outside of SLU, has no 
access to system, must be provided with PDF of protocol. NOTE: SLUH/SSM employees who collaborate 
regularly may obtain a guest SLU account if access to system is needed. 
-Department Chair: Official Department Chair, may or may not also be a member of research team, can view the 
protocol (not edit). NOTE: a proxy may be listed if the Chair is the PI. 
 
IMPORTANT NOTE: Human Subjects Protection Training is mandatory for all research team personnel. 
Principal Investigator (PI)   Mandatory 

PROTOCOL 
Protocol # 28225 
Pereira 
Biomedical Research 
Saint Louis University 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
Page 7 of 45 
 
 
7 
 
 
PI must be SLU affiliate. 
Name of Principal Investigator 
(Faculty, Staff or Student) 
 
Degree (MD/PhD) 
Title 
Pereira, Keith 
MD 
Assistant Professor 
Email 
Phone 
Fax 
pereirak@slu.edu 
577-8025 
Department Name 
Radiology 
 
Human Subjects Training Completed? 
Y 
WARNING: Proof of training must show below or the application will be 
returned. If your training information isn't showing, upload a copy in the 
Attachments section. 
Research Experience 
*?HELP?* 
Dr. Pereira is a board certified Interventional Radiologist As an Interventional Radiologist on tenure track, I have 
expertise in minimally invasive procedures (MIIPs) for PAD as a clinician focused in prevention and developing 
new PAD treatment options, 
Research Team Member Duties Picklist 
1. 
X  Recruitment 
2. 
X  Obtains consent 
3. 
X  Determine Subject Eligibility for Accrual 
4a. 
X  Subject Physical Examinations 
4b. 
X  Follow-up Visits including physical 
assessments 
6a. 
Administer and/or Dispense Study Drugs, 
Biologics or Devices (must be licensed) 
5. 
X  Perform study procedures or Specimen 
Collection 
6b. 
Receive, Store, Manipulate or Account for 
Study Drugs, Biologics or Devices 
7. 
X  Subject Randomization or Registry 
8. 
X  Collection of Subject Data 
9. 
X  Report Data (CRFs, e-CRFs, Spreadsheets) 
10. 
X  Data Analysis 
11a.   X  Review Adverse Events 
11b.   X  Treat and Classify Adverse Events 
12. 
Other (Please insert explanation below.) 
 
UserID 
CourseCompletionDate 
Course 
pereirak 
04-12-2016 
CITI Biomedical Research Basic 
Training 
 
Administrative Contact 
 
Name of Administrative Contact 
Degree 
Title 
Hardy, Anna 
RN, MPH 
Research Nurse 
 
 
 
 
Key Personnel (Research Team) 

PROTOCOL 
Protocol # 28225 
Pereira 
Biomedical Research 
Saint Louis University 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
Page 8 of 45 
 
 
8 
 
 
Name of Key Personnel 
(Research Team) 
Degree 
Title 
Department Name 
Manard, William 
MD 
Associate Professor 
Family and Community 
Medicine 
Gupta, Deepashree 
MD 
Assistant Professor 
IM-Endocrinology 
Hellebusch, Dana 
FNP 
Nurse Practitioner 
IM-Endocrinology 
Morley, John 
MD 
Professor 
IM-Geriatrics 
Gammack, Julie 
MD 
Associate Dean 
IM-Geriatrics 
Gorukanti, Srecharan 
MD Candidate 
Student 
Radiology 
Salamo, Russell 
MD candidate 
Student 
Radiology 
McLaughlin, Lauren 
NP 
Faculty/Staff 
Radiology 
Wilson-Flewelling, Scott 
MD candidate 
Student 
Radiology 
 
 
 
 
 
 
Department Chair  Mandatory 
 
The official Department Chair should be listed here. If the Department Chair is the PI, a proxy may be listed. 
Name of Department Chair 
Brown, Jeffrey 
Degree 
MD 
Title 
Professor 
Email 
jjbrown@slu.edu 
Phone 
(314) 268-5780 
Fax 
Department Name 
Radiology 
Is this individual also a member of the research team? 
N 
Human Subjects Training Completed? 
WARNING: Proof of training must show below or the application will be 
returned. If your training information isn't showing, upload a copy in the 
Attachments section. 
Research Experience 
*?HELP?* 
Research Team Member Duties Picklist 
1. 
Recruitment 
2. 
Obtains consent 
3. 
Determine Subject Eligibility for Accrual 
4a. 
Subject Physical Examinations 
4b. 
Follow-up Visits including physical 
assessments 
6a. 
Administer and/or Dispense Study Drugs, 
Biologics or Devices (must be licensed) 
5. 
Perform study procedures or Specimen 
Collection 
6b. 
Receive, Store, Manipulate or Account for 
Study Drugs, Biologics or Devices 

PROTOCOL 
Protocol # 28225 
Pereira 
Biomedical Research 
Saint Louis University 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
Page 9 of 45 
 
 
9 
 
 
7. 
Subject Randomization or Registry 
8. 
Collection of Subject Data 
9. 
Report Data (CRFs, e-CRFs, Spreadsheets) 
10. 
Data Analysis 
11a. 
Review Adverse Events 
11b. 
Treat and Classify Adverse Events 
12. 
Other (Please insert explanation below.) 
 
UserID 
CourseCompletionDate 
Course 
jjbrown 
01-31-2013 
CITI Biomedical Research Basic 
Training 
jjbrown 
01-29-2013 
Good Clinical Practice (GCP) 
 
Research Team Roles 
 
Name(s), Degree 
Department 
Experience 
Duties 
Pereira, Keith, MD 
Radiology 
Dr. Pereira is a board 
certified Interventional 
Radiologist As an 
Interventional Radiologist on 
tenure track, I have 
expertise in minimally 
invasive procedures (MIIPs) 
for PAD as a clinician 
focused in prevention and 
developing new PAD 
treatment options, 
Recruitment, Obtains 
consent, Determine 
Subject Eligibility for 
Accrual, Subject Physical 
Examinations, Follow-up 
Visits including physical 
assessments, Perform 
study procedures or 
Specimen Collection, 
Subject Randomization or 
Registry, Collection of 
Subject Data, Report Data 
(CRFs, e-CRFs, 
Spreadsheets), Data 
Analysis, Review Adverse 
Events, Treat and Classify 
Adverse Events 
Hardy, Anna, RN, MPH 
Radiology 
Anna is a clinical nurse with 
additional training on 
research 
Recruitment, Obtains 
consent, Collection of 
Subject Data, Data 
Analysis 
Manard, William, MD 
Family and 
Community Medicine 
Dr. William Manard provides 
full-spectrum primary health 
care for people and families 
of all ages. He specializes in 
preventive/wellness care, 
chronic disease 
management and mental 
health, using the latest 
information technology to 
aid him in ensuring quality 
care for his patients. 
Dr. Manard’s research 
interests include process 
and health system 
improvement, use of 
decision support 
mechanisms to provide 
Obtains consent, 
Determine Subject 
Eligibility for Accrual, 
Subject Physical 
Examinations , Perform 
study procedures or 
Specimen Collection, 
Collection of Subject 
Data, Report Data (CRFs, 
e-CRFs, Spreadsheets), 
Data Analysis 

PROTOCOL 
Protocol # 28225 
Pereira 
Biomedical Research 
Saint Louis University 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
Page 10 of 45 
 
 
10 
 
 
quality care, and use of 
interactive medical records 
to improve patient clinical 
outcomes. 
He is medical director and 
associate professor for the 
Department of Family 
Medicine at Saint Louis 
University School of 
Medicine and is faculty 
advisor for the Family 
Medicine Interest Group. 
Gupta, Deepashree, MD 
IM-Endocrinology 
Dr. Deepashree Gupta 
treats patients who have 
diabetes, thyroid disorders, 
thyroid cancer, and bone 
disorders. In her practice, 
she manages treatment 
through the use of insulin 
pumps, continuous glucose 
monitoring, thyroid 
ultrasound and biopsies. 
She also provides medical 
weight loss options, using 
the latest medications 
available. 
Dr. Gupta is interested in 
research that investigates 
changes in blood glucose 
levels after weight loss 
surgery. 
She is an assistant 
professor in the Department 
of Internal Medicine, 
Division of Endocrinology, 
Diabetes and Metabolism, at 
Saint Louis University 
School of Medicine. She 
serves as chair of the 
Inpatient Diabetes Advisory 
Committee. 
Dr. Gupta is a member of 
the Endocrine Society. 
Recruitment, Obtains 
consent, Subject Physical 
Examinations , Perform 
study procedures or 
Specimen Collection, 
Collection of Subject 
Data, Report Data (CRFs, 
e-CRFs, Spreadsheets), 
Data Analysis 
Hellebusch, Dana, FNP 
IM-Endocrinology 
Dana Hellebusch is a 
certified diabetes educator 
who provides diabetes 
management and 
counseling for her patients. 
She utilizes the latest 
technology in developing 
treatment plans, including 
the use of the insulin pump 
Recruitment, Obtains 
consent, Subject Physical 
Examinations , Perform 
study procedures or 
Specimen Collection, 
Collection of Subject 
Data, Report Data (CRFs, 
e-CRFs, Spreadsheets), 
Data Analysis 

PROTOCOL 
Protocol # 28225 
Pereira 
Biomedical Research 
Saint Louis University 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
Page 11 of 45 
 
 
11 
 
 
and continuous glucose 
monitoring. 
Hellebusch is a clinical staff 
instructor in the Department 
of Internal Medicine, 
Division of Endocrinology, 
Diabetes and Metabolism, at 
Saint Louis University 
School of Medicine. 
She is a member of the 
American Association of 
Diabetes Educators, the 
American Diabetes 
Association, and the 
American Association of 
Nurse Practitioners. 
Morley, John, MD 
IM-Geriatrics 
board certified by 
American Board of Internal 
Medicine (Endocrinology 
Diabetes & Metabolism) 
American Board of Internal 
Medicine (Geriatrics) 
American Board of Internal 
Medicine (Internal Medicine) 
Recruitment, Obtains 
consent, Subject Physical 
Examinations , Perform 
study procedures or 
Specimen Collection, 
Collection of Subject 
Data, Report Data (CRFs, 
e-CRFs, Spreadsheets), 
Data Analysis 
Gammack, Julie, MD 
IM-Geriatrics 
Dr. Julie Gammack 
specializes in geriatric 
medicine, long-term care, 
and post-acute care. She 
provides primary care 
services in her practice, and 
also offers geriatric 
assessment and dementia 
evaluation. Her areas of 
interest include coronary 
artery disease, end-of-life 
care, eating disorders, 
osteoporosis, and nutrition 
counseling, among other 
concerns specific to elderly 
patients. 
Dr. Gammack is a professor 
in the Department of Internal 
Medicine, Division of 
Geriatric Medicine, at Saint 
Louis University School of 
Medicine. 
She is an active member of 
the Society for Post-Acute 
and Long-Term Care 
Medicine (AMDA). 
Recruitment, Obtains 
consent, Determine 
Subject Eligibility for 
Accrual, Subject Physical 
Examinations , Administer 
and/or Dispense Study 
Drugs, Biologics or 
Devices (must be 
licensed) 

PROTOCOL 
Protocol # 28225 
Pereira 
Biomedical Research 
Saint Louis University 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
Page 12 of 45 
 
 
12 
 
 
Dr. Gammack is a leader in 
the field of geriatrics, named 
a Best Doctor by St. Louis 
Magazine several years 
running. 
Gorukanti, Srecharan, MD 
Candidate 
Radiology 
Sre Gorukanti is a first year 
medical student at Saint 
Louis University School of 
Medicine. He has previously 
done research with the 
Music Therapy program at 
the SLU Cancer Center 
ascertaining the effects of 
music therapy for patients 
with otolaryngological 
related cancers. He is 
currently seeking IRB 
approval to participate in a 
study involving digital ABIs 
on Peripheral Vascular 
Disease to expand on 
anatomical and 
hematological knowledge 
gained in medical school. 
He will be mentored by 
experienced research staff. 
Recruitment, Obtains 
consent, Determine 
Subject Eligibility for 
Accrual, Subject Physical 
Examinations , Follow-up 
Visits including physical 
assessments, Perform 
study procedures or 
Specimen Collection, 
Subject Randomization or 
Registry, Collection of 
Subject Data, Report Data 
(CRFs, e-CRFs, 
Spreadsheets), Data 
Analysis 
Salamo, Russell, MD candidate Radiology 
Russell Salamo is a 4th year 
medical student at Saint 
Louis University with 
intention of pursuing 
research in interventional 
radiology. He has previously 
been on two IRB protocols 
at Saint Louis University, 
Protocol ID: 27458 and 
26665. 
Russell will be mentored in 
this study by the PI 
Recruitment, Obtains 
consent, Subject Physical 
Examinations , Follow-up 
Visits including physical 
assessments, Perform 
study procedures or 
Specimen Collection, 
Subject Randomization or 
Registry, Report Data 
(CRFs, e-CRFs, 
Spreadsheets), Data 
Analysis, Treat and 
Classify Adverse Events 
McLaughlin, Lauren, NP 
Radiology 
Lauren has more than 10 
years of clinical trial 
experience from her 
positions at Washington 
University 
Recruitment, Obtains 
consent, Determine 
Subject Eligibility for 
Accrual, Perform study 
procedures or Specimen 
Collection, Collection of 
Subject Data, Report Data 
(CRFs, e-CRFs, 
Spreadsheets) 
Wilson-Flewelling, Scott, MD 
candidate 
Radiology 
Scott has been involved in 
several prospective studies, 
consenting subjects, data 
management, and analysis. 
Recruitment, Obtains 
consent, Determine 
Subject Eligibility for 
Accrual, Collection of 
Subject Data, Report Data 
(CRFs, e-CRFs, 

PROTOCOL 
Protocol # 28225 
Pereira 
Biomedical Research 
Saint Louis University 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
Page 13 of 45 
 
 
13 
 
 
Spreadsheets), Data 
Analysis 
--------------------------------------------------------------------------------------------- 
* * * Subject Population * * * 
 
 
Subject Population(s) Checklist 
Select All That Apply : 
X 
Adults 
Cognitively Impaired Subjects 
Employees (specifically targeted) 
Fetuses 
Minors (under 18) 
Neonates 
Non English Speaking Subjects 
Pregnant Women 
Prisoners 
Students (specifically targeted) 
Terminally Ill Subjects 
Wards of the State 
Other (any population that is not specified above) 
 
 
--------------------------------------------------------------------------------------------- 
* * * Study Location * * * 
 
 
Study Location(s) Checklist 
Indicate where the study will be conducted. Select all that apply: 
X 
Saint Louis University, Medical Center Campus 
Saint Louis University, Frost Campus 
Saint Louis University, Madrid Campus 
X 
Saint Louis University, SLUCare Practice Locations 
SSM STL (DePaul Hospital, St. Mary's Health Center, St. Joseph (St. Charles, Wentzville, Lake Saint 
Louis), St. Clare) 
Cardinal Glennon Children's Medical Center 
X 
Saint Louis University Hospital (SSM Health- SLU Hospital) 
SLU-SSM Cancer Center Research Alliance Sites 
Other (In the box below, list any off-campus institutions or locations and describe the activities being 
conducted there. Please provide letters of cooperation and/or IRB approvals from each location to 
document support/approval of the study. You may provide such documentation as it becomes available, but 
you may not begin work at those sites until documentation of support is provided to the IRB.) Please refer 
to the Guidance for involving non-SLU institutions in human subject research. 

PROTOCOL 
Protocol # 28225 
Pereira 
Biomedical Research 
Saint Louis University 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
Page 14 of 45 
 
 
14 
 
 
--------------------------------------------------------------------------------------------- 
* * * General Checklist * * * 
 
 
General Checklist 
Select All That Apply : 
Collection of Specimens 
Data collection via e-mail or the Internet 
Deception/Incomplete Disclosure 
Dietary Supplements, Vitamins, and Other Food Agents 
X 
FDA Approved Device 
FDA approved  drugs, reagents, other chemicals administered to subjects (even if they are not being 
studied), or biologic products 
Genetic Testing 
HIV Testing 
Human blood, cells, tissues, or body fluids 
International Research or Research on International Populations 
Investigational drugs, reagents, chemicals, or biologic products 
Investigational Device 
X 
Investigator Initiated Study 
*?HELP?* 
X 
Medical Records 
Photography, Video, or Voice-Recording Subjects 
Questionnaires and/or tests 
Radioisotopes/radiation-producing machines, even if standard of care 
rDNA/Gene Transfer Therapy 
Registry(ies) 
Specimens to be stored for future research projects (must be in consent form) 
Study of existing data or specimens 
X 
University Indemnified Study (SLU is responsible for liability coverage) 
*?HELP?* 
X 
Other (clarify in text box to the right) 
Ankle Brachial Index 
 
 
Single Use. Provide a brief summary and justification for the Single Use Therapy. Note: This application will 
refer to research. For Single Use applications it is understood that 'research' will mean 'therapy'. 
 
 
--------------------------------------------------------------------------------------------- 
* * * Funding * * * 
 
 
Funding Checklist 
 
NONE 

PROTOCOL 
Protocol # 28225 
Pereira 
Biomedical Research 
Saint Louis University 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
Page 15 of 45 
 
 
15 
 
 
 
 
 
Funding - Saint Louis University 
 
What type of Saint Louis University funding? 
SLU eRS # 
SPARK Microgrant 
n/a 
 
 
 
 
 
 
 
 
 
 
NOTE:  Applicable grant application, contract or subcontract, investigator's brochure, and sponsor's 
protocol (for all industry sponsored clinical trials) must be attached. You will be prompted for these in 
section #16 (Attachments). 
 
--------------------------------------------------------------------------------------------- 
* * * Expedited Paragraphs * * * 
To request an Expedited Review, check the appropriate category(ies) below. Provide justification for your request 
for Expedited Review. 
 
 
To qualify for expedited review, research activities must (1) present no more than minimal risk to human subjects, 
and (2) involve only procedures listed in one or more of the categories below. 
 
 
 
 
X 
1. 
Clinical studies of drugs and medical devices only when condition (a) or (b) is met. 
 
 
a) 
Research on drugs for which an investigational new drug application (21 CFR Part 31, 32) is not 
required. (Note: Research on marketed drugs that significantly increases the risks or decreases the 
acceptability of the risks associated with the use of the product is not eligible for expedited review.) 
 
 
b) 
Research on medical devices for which 
 
(i) 
An investigational device exemption application (21 CFR Part 812) is not required; or 
(ii) 
The medical device is cleared/approved for marketing and the medical device is being used in 
accordance with its cleared/approved labeling. 
The medical device is cleared/approved for marketing and the medical device is being used in 
accordance with its cleared/approved labeling. 
 
 
2. 
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: 

PROTOCOL 
Protocol # 28225 
Pereira 
Biomedical Research 
Saint Louis University 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
Page 16 of 45 
 
 
16 
 
 
a) 
From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts 
drawn may not exceed 550 ml in an 8-week period and collection may not occur more frequently 
than 2 times per week; or 
 
 
 
From other adults and children, considering the age, weight, and health of the subjects, the 
collection procedure, the amount of blood to be collected, and the frequency with which it will be 
collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per 
kg in an 8-week period and collection may not occur more frequently than 2 times per week. 
 
Children are "persons who have not attained the legal age for consent to treatments or 
procedures involved in the research, under the applicable law of the jurisdiction in which 
the research will be conducted." 
3. 
Prospective collection of biological specimens for research purposes by non-invasive means. 
EXAMPLES: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or 
if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a 
need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected 
either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric 
solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the 
membrane prior to or during labor; (h) supra-and subgingival dental plaque and calculus, provided the 
collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is 
accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by 
buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization. 
 
 
X 
4. 
Collection of data through non-invasive procedures (not involving general anesthesia or sedation) 
routinely employed in clinical practice, excluding procedures involving X-rays or microwaves. Where 
medical devices are employed, they must be cleared/approved for marketing. (Studies intended to 
evaluate the safety and effectiveness of the medical device are not generally eligible for expedited 
review, including studies of cleared medical devices for new indications.) 
 
 
EXAMPLES: (a) physical sensors that are applied either to the surface of the body or at a distance and do not 
involve input of significant amounts of energy into the subject or an invasion of the subjects' privacy; (b) 
weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, 
electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, 
ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiology; (e) moderate exercise, 
muscular strength testing, body composition assessment, and flexibility testing where appropriate given the 
age, weight and health of the individual. 
Ankle Brachial Index for Peripheral Arterial Disease 
 
X 
5. 
Research involving materials (data, documents, records, or specimens) that have been collected, or 
will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: 
Some research in this category may be exempt from the HHS regulations for the protection of human 
subjects. 45CFR 46.101(b)(4). This listing refers only to research that is not exempt.) 
Will be accessing medical records to collect data that has been collected, or will be collected solely for 
nonresearch purposes. 

 
17 
 
PROTOCOL 
Biomedical Research 
Saint Louis University 
Protocol # 28225 
Pereira 
 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
 
6. 
Collection of data from voice, video, digital, or image recordings made for research purposes. 
 
 
 
7. 
Research on individual or group characteristics or behavior (including, but not limited to, research on 
perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and 
social behavior) or research employing survey, interview, oral history, focus group, program 
evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in 
this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 
46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.) 
 
 
 
8. 
 [FOR IRB use only]. Continuing review of research previously approved by a convened IRB only 
when condition (a), (b), or (c) is met. 
 
a) 
Previously approved research where 
(i) 
The research is permanently closed to the enrollment of new subjects; 
(ii) 
All subjects have completed all research-related interventions; and 
(iii) 
The research remains active only for the long term follow-up of subjects. 
 
 
b) 
Previously approved research where no subjects have been enrolled and no additional 
risks have been identified. 
 
 
c) 
Previously approved research where the remaining research activities are limited to data 
analysis. 
 
 
9. 
 [FOR IRB use only]. Continuing review or research not conducted under an investigational new drug 
application or investigational drug exemption where expedited categories two (2) through eight (8) do 
not apply but the IRB has determined and documented at a convened meeting that the research 
involves no greater than minimal risk and no additional risks have been identified. 
--------------------------------------------------------------------------------------------- 
* * * Background, Purpose, Study Procedures * * * 
Title 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in detecting peripheral 
arterial disease: A single center, prospective clinical trial 
 
 
Complete Sections 1 - 16. In sections that allow reference to sponsor protocol or grant, clearly state section and 
page numbers. Any information that is different or specific to the local site should be in the SLU application. 
Specify N/A as appropriate. 
1. Background 
 
Page numbers from a sponsor's protocol/grant may be referenced in 1a and 1b. 
 
 
a) 
Provide an introduction and background information. Describe past experimental and/or clinical 
findings leading to the formulation of the study, if applicable. Investigator Initiated studies must 
cite references in the response provided or attach a bibliography.    *?HELP?* 
 
 
 
Page 17 of 45 

 
18 
 
PROTOCOL 
Biomedical Research 
Saint Louis University 
Protocol # 28225 
Pereira 
 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
 
 
cite references in the response provided or attach a bibliography. 
*?HELP?* 
Peripheral artery disease (PAD) affects 8–18 million in the US and is an economic burden, 
currently estimated to be greater than cancer and heart disease. Older age (> 65 years), 
smoking, diabetes and kidney diseases are some risk factors associated with PAD and are 
known to have increased morbidity and mortality[1, 2]. PAD progression directly results in 
claudication, impaired walking, and amputation. Amputation is not benign - impacts are physical 
and emotional. Recovery from amputation involves long-term rehabilitation. The American 
Heart Association (AHA) in 2016 guidelines suggests an algorithm for diagnosis and 
management of PAD. They recommend a collaborative multidisciplinary team approach 
between the primary care physician and specialists including; a diabetologists/ endocrinologist, 
smoking cessation expert, hypertension and lipid specialist, interventional radiologist, vascular 
surgeon, orthopedist, neurologist, wound healing expert, and/or others for ‘the greatest chance 
of providing optimal care for the patient with PAD’[3]. 
 
Early detection is critical for mitigating PAD progression. Ankle-brachial index (ABI) testing is 
recommended by the US Preventative Services Task Force as an affordable and effective 
screening tool for evaluating PAD risk[3]. ABI testing is especially useful in primary care 
settings allowing for earlier diagnosis and treatment. Several ABI methods are used; classically 
this test uses a device for measuring blood pressure with an inflatable cuff, and blood pressure 
measurements are taken at the upper arm and the ankle; healthcare providers have used a 
doppler probe to detect audible systolic pressure signals within the arteries - Doppler ABI. 
Barriers to implementation include; time required to conduct tests, training and required 
technical skills. Hence, Doppler-based ABI in primary care has been limited. Recently designed 
oscillometric (manual or digital with automatic electronic calculation of blood pressure) and 
photophlethysmographic devices are now available. However current guidelines do not endorse 
the use of these newer devices but recommend the hand-held doppler technique[4]. 
 
Digital ABI is noninvasive, automated ABI using pulsatile blood volume changes - 
plethysmography, irrespective of vessel compressibility. The QuantaFlo™ (Semler Scientific, 
Inc.) is an innovative, 510K FDA approved device that provides bilateral, non-invasive 
physiologic studies of upper and lower extremity arteries using volume plethysmography of the 
posterior tibial and anterior tibial/dorsalis pedis arterial distributions. QuantaFlo™ uses an 
optical sensor attached onto a digit in the hand and feet to assess extremity blood volume. It 
then displays a signal, directly related to blood volume, on a Volume Plethysmography Chart 
used to calculate PAD probability. This test is easy to use and portable, delivering fast, 
accurate results in ~5 minutes; an attractive option in primary care settings. While maintaining 
accuracy, results comparing digital methods to Doppler show concordance above 90%. The 
American Medical Association (AMA) concluded, “Evaluation of the digits in both legs with 
volume plethysmography is appropriate for this code provided that an ankle/brachial index (ABI) 
be performed.” QuantaFlo™ meets both of these standards. 
 
ABI ≤ 0.9 has been used as the criterion for diagnosing PAD based on ACC/AHA guidelines for 
the management of patients with PAD [3]; the cutoff value of ABPI ≤0.9 it has been reported 
that the sensitivity of diagnosing PAD was 83% to 85% and a specificity of 95% to 100% [5]. ABI 
has been validated against lower extremity contrast angiography obtaining high sensitivity (85%–
95%) and specificity (90%–100%), for diagnosing PAD [6, 7]. Many studies have reported more 
than 95% of sensitivity and specificity of colour duplex ultrasound scan in detecting a significant 
stenosis of the arteries [8, 9]. 
 
 
Please save frequently 
 
 
b) 
Describe any animal experimentation and findings leading to the formulation of the study, if 
there is no supporting human data. 
 
 
 
 
Page 18 of 45 

 
19 
 
PROTOCOL 
Biomedical Research 
Saint Louis University 
Protocol # 28225 
Pereira 
 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
 
 
N/A 
 
 
2. Purpose of the study 
 
 
a) 
Provide a brief lay summary of the project in <200 words. The lay summary should be readily 
understandable to the general public. 
QuantaFlo™ (Semler Scientific, Inc.) is a novel, noninvasive, 510K FDA approved digital device 
that is used as a screening tool to measure ABI of patients at risk of PAD. This single center 
prospective clinical trial will evaluate the sensitivity and specificity of digital ABI in detecting 
PAD using color Doppler ultrasound and ‘gold standard’ angiography as reference. Specifically 
in participant undergoing dialysis and who cannot undergo ABI using pressure cuffs dialysis 
grafts/ fistulae in the arms, we will evaluate the value of digital ABI in detecting PAD. 
 
Page numbers from a sponsor's protocol/grant may be referenced in 2b and 2c. 
b) 
List your research objectives (specific aims & hypotheses of the study). 
Primary aim: 
To evaluate the sensitivity and specificity of digital ABI in diagnosing PAD using color Doppler 
ultrasound and ‘gold standard’ angiography as reference. 
Secondary aim: 
•To correlate the digital ABI index with symptoms of PAD. 
•To evaluate the value of digital ABI in detecting PAD in patients on dialysis in whom the 
presence of dialysis grafts/ fistulae in the arms would have prohibited the use of ABI using 
pressure cuffs. 
 
 
Please save frequently 
 
 
c) 
Describe the study design (e.g., single/double blind, parallel, crossover, control, experimental, 
observational, etc.). If the study is investigator-initiated, a timeline for individual subject 
recruitment, follow-up, and analysis for the study is required. Also, indicate if the subjects will be 
randomized. 
This is a pilot, Single Center, Prospective study. A total of 100 participants will be enrolled 
 
 
d) 
If subjects will be given placebo, please justify placebo use. 
*?HELP?* 
N/A 
 
 
3. Study Procedures 
 
a) 
N 
Is this project a multicenter study (i.e., same project is conducted elsewhere by a 
different investigator) OR does this study involve conduct of research at multiple sites? 
Is SLU acting as a coordinating center for other sites OR is the SLU PI a direct recipient 
of a federal grant for this research? If yes, complete and attach the Supplemental 
Application for Coordinating Center Activities. 
 
 
 
Page 19 of 45 

 
20 
 
PROTOCOL 
Biomedical Research 
Saint Louis University 
Protocol # 28225 
Pereira 
 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
 
 
Will the SLU site be participating in all parts/procedures/arms of the study? 
If No, explain what SLU will NOT participate in: 
 
 
Please save frequently 
 
 
Page numbers from a sponsor's protocol/grant may be referenced in 3b, 3c, and 3d. 
 
 
b) 
Describe all the procedures, from screening through end-of-study, that the human subject must 
undergo in the research project, including study visits, drug treatments, randomization and the 
procedures that are part of standard of care. Specify which procedures are for research and 
which are standard of care. Please note: The box below is for text only. If you would like to add 
tables, charts, etc., attach those files in the Attachment section (#16). 
1.Screening sites: The digital ABI screening test will be offered at various outpatient clinics in 
departments belonging to family medicine, endocrinology, geriatric medicine. 
 
2.Participant information: Participant will get information about Peripheral arterial disease based 
on a poster which will be placed in the waiting areas as well as flyers that will be presented to 
them during their routine clinic visit to the respective specialists. 
3.Screening questionnaire: On registration at these respective clinics, all patients in the clinic 
will be given the screening questionnaire by the front desk. Patient will fill out the questionnaire, 
saying YES or NO. If ANY of the questions is a YES - this is an indication for doing a screening 
digital ABI. 
The screening questionnaire is considered part of clinical care, and would occur regardless of 
this research study. 
 
4.If ANY of the questions is a YES - this is an indication for doing a screening digital ABI. This 
patient will then be approached by the Research Coordinator and asked if they want to 
participate. The Research Coordinator will then consent the patient for the study. 
 
5. After consent, an EPIC order will be placed for the ABI. The medical assistant / nurse/ front 
desk will speak to the study coordinator to put an order for a digital ABI in EPIC. Along with the 
order, the answers from the screening questionnaire will be entered into EPIC via a flowsheet 
that has been created. The screening questionnaire will be uploaded in EPIC regardless of this 
research study. 
6.Perform Digital ABI: 
Performing ABI is within the normal duties of any nurse/ medical assistant 
 
•Will be performed by the nurse/medical assistant/ research coordinator with training to perform 
this test 
•The participant will be placed in the supine position, with the arms and legs at the same level 
as the heart, for a minimum of 5 minutes before measurement. Foot warmers will be placed 
during this time on the patients feet with foot liners. The foot warmers are like a heating pad for 
feet. 
•The optical sensor (similar to a pulse oximeter) will be placed sequentially in the fingers of the 
hands and feet: Right and left hand fingers and then right and left feet toes. 
•Usually each digit takes about 15 seconds to obtain a waveform 
•At the end of 60 seconds, an automated digital ABI will be generated. 
IF the data produced seem unreliable, sometimes indicated by the device we will ask the 
 
 
 
Page 20 of 45 

 
21 
 
PROTOCOL 
Biomedical Research 
Saint Louis University 
Protocol # 28225 
Pereira 
 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
 
 
participant to do exercise 25-40 heal lifts (until they can feel it in their calf muscle). and then the 
test with the pulse Oximeter will be repeated. 
 
6.Interpreting ABI: Interventional Radiology physician will pick up these studies from EPIC at 
the end of the day and put in a formal report in EPIC. 
7.Clinical course: If based on Screening questionnaire and digital ABI, 
I.Participant is diagnosed with PAD- the referring physician and participant will receive a phone 
call about the same. He/ she will then be advised any further testing/ referral to IR clinic. 
II.There is no evidence of PAD- no further action will be taken. The participant will be informed 
of the same. 
 
8. The data of all patients who have answered the questionnaire will be accessed. This includes 
those patients who are screened but do not meet the criteria to undergo digital ABI. Those who 
were screened, do meet the criteria to undergo the digital ABI but choose not to will be asked if 
their data can still be used for this research study (and will be asked to sign a separate consent 
document). 
 
 
c) 
If the proposed study is a clinical trial where a drug, vaccine, device or other treatment is 
compared to a placebo group or comparison treatment group, what are the guidelines or 
endpoints by which early decisions regarding efficacy or lack of efficacy can be made? For 
example, it may be reasonable to stop enrollment on a study when efficacy has already been 
clearly demonstrated, to avoid unnecessary enrollments of additional subjects. Alternatively, it 
may be reasonable to stop enrollment when it is clear that efficacy will never be demonstrated, 
given the statistical power of the study as designed. Describe the guidelines that are in place to 
assist in making these determinations, if relevant to the proposed study. 
N/A 
 
 
d) 
Describe how data analysis will be performed (statistical tests, methods of evaluating data) and 
indicate the smallest group/unit for which separate reporting will occur. For studies involving a 
questionnaire, if data and reliability information are available, please describe or provide 
references. For full board, unfunded studies describe sample size determination and power 
analysis. If none, please justify. 
Statistical analysis will be performed using R version 3.3.2 or newer (R Core Team, Vienna, 
Austria).Binary variables will created for each sign, symptom, or risk factor based on the 
corresponding questionnaire response. Standard summary statistics will be calculated for study 
variables of interest. For continuous variables, statistics included the number of observations 
(N), mean, standard deviation, and 95% confidence interval. Categorical variables will be 
summarized in frequency distributions. The results of ABI will be categorized based on the ABI 
index obtained as normal (>0.9), calcified arteries (>1.4), Mild to moderate disease (0.4-0.9), 
Severed disease- <0.4 and compared to symptoms (e.g. asymptomatic, claudication, critical 
limb ischemia). A ‘Positive ABI’ will then be compared to gold standard ‘angiography’; if 
angiography shows evidence of PAD, this will be termed ‘angiographic positive’. Sensitivity will 
be defined as the proportion of ‘ABI positive results’ out of the number of samples which were 
actually ‘angiographically positive’. When there are no positive results, sensitivity will not be 
defined and a value of NA is returned. Similarly, when there are no negative results, specificity 
will not defined and a value of NA is returned. Similar statements will be true for predictive 
values. The positive predictive value will be defined as the percent of predicted positives that are 
actually positive while the negative predictive value will be defined as the percent of negative 
positives that are actually negative. 
 
 
Please save frequently 
 
 
 
 
Page 21 of 45 

 
22 
 
PROTOCOL 
Biomedical Research 
Saint Louis University 
Protocol # 28225 
Pereira 
 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
 
 
 
e) 
State if deception (including incomplete disclosure of study purpose/procedures) will be used. If 
so, describe the nature of the deception and provide a rationale for its use. Also, describe 
debriefing procedures or justify a waiver of the requirement to debrief. NOTE: for studies using 
deception, an alteration of consent must be justified in the Informed Consent section of the 
protocol (#13) and the debriefing script/statement must be uploaded in the Attachments section 
(#16). See IRB Deception Guidelines. 
 
 
f) 
Is there an accepted standard of care and/or standard practice at SLU for the 
Y 
condition/disease/situation being studied? This information will assist in comparing 
the risk/benefit ratio of study procedures relevant to usual care that would be 
received outside of the research context. *?HELP?* 
 
If yes, please describe the standard of care and standard practice at SLU for the 
condition/disease/situation being studied. 
Several ABI methods are used, with Doppler ABI being most common. 
 
Currently at Saint Louis University hospital, patients who have signs and symptoms of PAD 
undergo traditional ABI or Doppler ultrasound. Traditional ABI involves a slightly different 
process involving the use of blood pressure cuffs and manual measurement of flow using 
Doppler. Some patient may also receive angiography, which involves am injection of a dye into 
the artery of the leg to evaluate for blocks in arteries. 
 
 
g) 
Does this study involve any diagnostic imaging, labwork or genetic testing that could Y 
result in clinical discovery (diagnoses, genetic mutations, etc.)? Note that this could 
include discovery that is expected (related to the research) or incidental (not related 
to research aims, but possible, like a mass/shadow found in imaging despite not 
looking for it). 
 
 
If yes, please describe and include whether there are plans to share findings with study 
participants. 
Yes we may discover the participant has an undiagnosed PAD. This information will be shared 
with the subjects. 
 
 
h) 
Is this study subject to the NIH Genomic Data Sharing Policy? 
N 
 
The NIH GDS policy applies to all NIH-funded research that generates large-scale 
human genomic data as well as the use of these data for subsequent research and 
includes: genome-wide association studies (GWAS), single nucleotide 
polymorphisms (SNP) arrays, and genome sequence, transcriptomic, 
metagenomics, epigenomic and gene expression data, irrespective of NIH funding 
mechanism. Click here for more specific examples. 
 
 
--------------------------------------------------------------------------------------------- 
* * * Radioisotopes or Radiation Machines * * * 
You have not selected the Radioisotopes option in the General Checklist. If you would like to add Radioisotopes 
information, please select the option to enable this section. 
 
 
 
 
Page 22 of 45 

PROTOCOL 
Protocol # 28225 
Pereira 
Biomedical Research 
Saint Louis University 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
Page 23 of 45 
 
 
23 
 
 
 
4.  Radioisotopes or Radiation Machines 
 
In this section, investigators must enter all radiation usage associated with the protocol. 
 
 
Important: Protocols that involve non-standard of care radioactive materials (which includes the terms 
"radioisotopes", "radionuclides", "radiopharmaceuticals", and "nuclear medicine studies", e.g., "PET", "MUGA", 
"Zevalin", and/or specific radionuclides such as "F-18", "Tc-99m", "Th-201", "I-131", "Ra-233", "Y-90", etc.) will 
receive review by the Radiation Safety Officer (RSO) and/or Radiation Safety Committee (RSC). In these cases, 
submission to the RSO/RSC should occur first, even before submission to IRB. For more information on how to 
submit for radiation safety review, see RSC instructions or contact the Radiation Safety Officer at 977-6895. 
 
 
(1) It is the responsibility of the PI to assure the accuracy and completeness of the data submitted in this section, 
consistent with guidelines provided below. (2) For projects requiring radiation procedures, please refer to this 
guidance. 
 
 
a) 
If applicable, list and quantify the radiographic diagnostic and therapeutic procedures associated with 
this protocol by clicking "Add" and adding to Table 1 below. (Includes X-ray, fluoroscopy, CT, 
radioactive materials, nuclear medicine, PET-CT, radiation oncology, accelerator, Cyber Knife 
procedures, etc.) 
 
 
 
 
b) 
Total estimated research radiation dose * : 
 
 
 
* Calculate from the table above by adding the Effective Dose Subtotals for all procedures. 
 
 
 
 
 
NOTE: Informed Consent Radiation Exposure Risk Statement- The applicant must insert the appropriate 
Informed Consent Radiation Exposure Risk Statement template language into the SLU IRB Informed Consent, 
inclusive of applying the total estimated research radiation dose specified in item b) from the table above, as 
instructed in the SLU IRB Informed Consent Template. Contact the IRB Office at 977-7744 or irb@slu.edu with 
any questions. 
 
 
 
--------------------------------------------------------------------------------------------- 
* * * Devices * * * 
5. Devices 
 
a) Please list in the space below all investigational devices to be used on subjects during this study. 

PROTOCOL 
Protocol # 28225 
Pereira 
Biomedical Research 
Saint Louis University 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
Page 24 of 45 
 
 
24 
 
 
b) Please list in the space below all FDA approved devices to be used on subjects during this study. 
 
 
FDA Approved Devices 
 
Device Name 
Manufacturer 
Provide IDE #. Documentation 
of IDE # required unless 
imprinted on sponsor protocol 
(attach in section #16). 
Quantaflo 
Semler Scientific, Inc 
 
 
 
--------------------------------------------------------------------------------------------- 
* * * Drugs, Reagents, Chemicals, or Biologic Products * * * 
6. Drugs, Reagents, Chemicals, Biologic Products, or Dietary Supplements, Vitamins, and Other Food Agents 
 
Pilot 
Phase I 
Phase II 
Phase III 
Phase IV 
Not Phased 
 
List placebo if it is considered a drug (contains more than inactive ingredients). For example, normal saline 
is considered a drug that should be listed, whereas placebo tablets are usually inert ingredients that do not 
need to be listed. 
 
 
b) 
Please list in the space below all investigational drugs, reagents or chemicals to be administered to 
subjects during this study. Attach all applicable Investigator Brochures in section #16 (Attachments). 
 
 
 
c) 
Please list in the space below all FDA approved drugs, reagents, chemicals to be administered to subjects 
during this study. Attach all applicable package inserts in section #16 (Attachments). 
 
 
 
d) 
Please list in the space below all dietary supplements, vitamins, minerals, or foods to be administered to 
subjects during this study. 
 
 
 
Please read the IND Statements. 
 
 
--------------------------------------------------------------------------------------------- 
* * * Other Levels Of Review * * * 
7. Other Levels Of Review 
 
1. University Radiation Safety 

PROTOCOL 
Protocol # 28225 
Pereira 
Biomedical Research 
Saint Louis University 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
Page 25 of 45 
 
 
25 
 
 
Protocols that involve non-standard of care radioactive materials (which includes the terms 
"radioisotopes", "radionuclides", "radiopharmaceuticals", and "nuclear medicine studies", e.g., "PET", 
"MUGA", "Zevalin", and/or specific radionuclides such as "F-18", "Tc-99m", "Th-201", "I-131", "Ra-223", 
"Y-90", etc.) will receive review by the Radiation Safety Officer (RSO) and/or Radiation Safety 
Committee (RSC). For information on how to submit for radiation safety review, see RSC instructions or 
contact the Radiation Safety Officer at 977-6895. 
 
X 
Not Applicable 
Yes, study involves radioactive materials (per instructions, submit to RSC before IRB) 
 
 
2. Institutional Biosafety 
 
Experiments involving the deliberate transfer of Recombinant or Synthetic Nucleic Acid Molecules (e.g., 
Gene Transfer), or DNA or RNA derived from Recombinant or Synthetic Nucleic Acid Molecules, or 
Microorganisms containing Recombinant or Synthetic Nucleic Acid Molecules and/or infectious agents 
(including select agents and toxins as defined by CDC and/or Animal and Plant Health Inspection Service 
(APHIS)) into one or more human research participants must be reviewed by the SLU Biological Safety 
Officer. Most of these protocols also require review and approval by the SLU Institutional Biosafety 
Committee (IBC). Please contact the SLU Biological Safety Officer at 977-6888 for more information. 
 
X 
Not Applicable 
Yes, study requires Institutional Biosafety review 
 
 
3. Pharmacy, Therapeutics, Nutrition, and Transfusion (PTNT) Committee 
 
Saint Louis University Hospital requires that all research involving the administration of medications 
within the hospital (including outpatient areas such as the Emergency Department, Outpatient Center, 
Saint Louis University Hospital-South Campus, etc.) be reviewed and approved by the Pharmacy, 
Therapeutics, Nutrition, and Transfusion (PTNT) Committee and that study drugs are received, stored, 
prepared, and dispensed by the Hospital's Department of Pharmacy Services. Please contact the 
Investigational Drug Services Clinical Pharmacist at 268-7156 or SLUH-IDS@ssmsluh.com for more 
information. 
 
X 
Not Applicable 
Yes, study requires PTNT review 
 
 
4. Saint Louis University Hospital 
 
All research involving Saint Louis University Hospital, including the Emergency Department, inpatient or 
outpatient services (including outpatient surgery at ABI and the infusion center at DOB) and medical 
record access, requires approval from the Saint Louis University Hospital Research Review Committee 
prior to study initiation. This process is designed to facilitate compliance with state and federal 
regulations as they pertain to research in hospitals and clinical research billing. Documents should be 
submitted as soon as possible, or at the latest, concurrently with IRB submission. Please contact the 
Research Compliance Office at 577-8113 or sluh-research@ssmhealth.com of the SLU Clinical Trials 
Office (CTO) at 977-6335 or clinical-trials-office@health.slu.edu for more information. 

 
26 
 
PROTOCOL 
Biomedical Research 
Saint Louis University 
Protocol # 28225 
Pereira 
 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
 
Not Applicable 
X 
Yes, study requires Saint Louis University Hospital review 
 
 
5. SSMSL 
 
All research involving SSMSL locations (including Cardinal Glennon), including inpatient or outpatient 
services and medical record access, requires approval from the SSM STL or SSM Cardinal Glennon 
Research Business Review (RBR) prior to study initiation. This process is designed to facilitate 
compliance with state and federal regulations as they pertain to research in hospitals and clinical 
research billing. While researchers can begin to complete the SSM RBR form at any time, the form 
should not be submitted until the IRB and the CTO have approved the study. Please contact the SSMSL 
Office at 989-2058 or Marcy.Young@ssmhealth.com for more information. 
 
Not Applicable 
X 
Yes, study requires RBR review 
 
 
 
6. &nbspDoes this project require registration on ClinicalTrials.gov, and/or is this project 
Y 
subject to the NIH GCP Training Requirement? (Select "Yes" if either apply) 
 
Registration may be required if any of the following apply: 1) The project meets the 
FDAAA definition of an "Applicable Clinical Trial", which requires registration on 
ClinicalTrials.gov. 2) As of January 1, 2017, a new NIH policy mandated biomedical and 
behavioral "Clinical Trials" to be registered on ClinicalTrials.gov. In addition, NIH policies 
require personnel on NIH "Clinical Trials" to take GCP training every three years. 3) 
Registering may be required for Journal Publication (ICMJE). Please review relevant 
definitions here. Contact the CTO at clinical-trials-office@slu.edu with questions about 
registering on ClinicalTrials.gov and refer to the training page of the IRB website for 
information on NIH GCP Training requirements. 
 
 
 
 
 
--------------------------------------------------------------------------------------------- 
* * * Subject Population * * * 
8.  Subject Population - In the space below, please detail the participants that you are requesting to recruit 
(include description of each group requested) 
a) 
Expected age range of subjects. (For example ≥ 18 yrs to 90 yrs). 
18 years to 90 years old 
 
 
b) 
Number of evaluable subjects to be accrued at SLU or SLU site (this includes all 
sites under the direction of the SLU PI). 
750 
 
 
Exceeding the number listed here is a protocol violation. Prior IRB approval is required if additional 
participants are to be accrued. If applicable, this number should be consistent with your power analysis 
described in 3d. 
 
 
 
 
Page 26 of 45 

 
27 
 
PROTOCOL 
Biomedical Research 
Saint Louis University 
Protocol # 28225 
Pereira 
 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
 
 
 
c) 
Number of evaluable subjects to be accrued study wide. *?HELP?* 
750 
 
 
d) 
If including vulnerable populations (<a 
href=https://www.slu.edu/Documents/research/IRB/Minors_in_Research.doc target=_blank>minors, <a 
href=https://www.slu.edu/Documents/research/IRB/Pregnant_Women_Fetuses.docx 
target=_blank>pregnant women and fetuses, <a 
href=https://www.slu.edu/Documents/research/IRB/Neonates.docx target=_blank>neonates, <a 
href=https://www.slu.edu/Documents/research/IRB/Non-English_Speaking_Subjects.doc 
target=_blank>non-English speaking, economically or educationally disadvantaged, <a 
href=https://www.slu.edu/Documents/research/IRB/Prisoner_Research.doc target=_blank>prisoners, <a 
href=https://www.slu.edu/Documents/research/IRB/Adults_Unable_to_Provide_Consent.docx 
target=_blank>adults temporarily or permanently unable to consent for themselves): 1) provide the rationale 
for the importance of including this population in the research, and 2) specify the measures being taken to 
minimize risks to potentially vulnerable subjects. Click on hyperlinks to access <a 
href=https://www.slu.edu/division-of-research-administration-home/institutional-review-board-(irb)/general- 
guidelines target=_blank>SLU Guidelines containing additional considerations and strategies for mitigating 
risks. 
n/a 
 
 
e) 
If women, minorities, or minors are not included, a clear compelling rationale must be provided unless not 
applicable. Examples for not including minors: disease does not occur in children; drug or device would 
interfere with normal growth and development; etc. If federally funded reference appropriate section of the 
sponsors protocol/grant. *?HELP?* 
Minors will not be included in this study as they do not present to the study locations nor are they at risk of 
PAD. 
 
 
f) 
If any specifically targeted subjects are students, employees, or laboratory personnel, specify the measures 
being taken to minimize the risks and the chance of harm to these potentially vulnerable subjects. See <a 
href=https://www.slu.edu/division-of-research-administration-home/institutional-review-board-(irb)/general- 
guidelines target=_blank>SLU Guidelines for additional considerations and strategies for mitigating risks. 
 
 
 
g) 
Describe how potential subjects will be identified for recruitment (e.g., chart review, referral from individual's 
treating physician, those individuals answering an ad). How will potential participants learn about the 
research, and how will they be recruited (e.g., flyer, e-mail, web posting, telephone, etc.)? Upload 
recruitment materials in the Attachment Section (#16). Important to remember: potential subjects cannot be 
contacted before IRB approval. NOTE: The use of SLU owned websites in an approved SLU format (e.g., 
Cancer Center website, etc.) are always approved methods of recruitment. 
This portable system will be placed in primary care and geriatric offices, endocrinology/diabetic clinics. 
Patients will complete the screening questionnaire (SOC) and if they are indicated for the ABI will be 
approached and consented for participation in the protocol. 
A recruitment poster will be displayed in the clinic outpatient patient areas to educate patients about risks 
of PAD and need for ABI. 
 
A description of this study and study results will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. This website will not include information that can identify you. You can search this website at 
any time. 
 
--------------------------------------------------------------------------------------------- 
 
 
 
 
Page 27 of 45 

 
28 
 
PROTOCOL 
Biomedical Research 
Saint Louis University 
Protocol # 28225 
Pereira 
 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
 
 
 
 
8. Subject Population (continued) 
* * * Subject Population * * * 
Page numbers from a sponsor's protocol/grant may be referenced in 8h. 
 
h) 
Inclusion and Exclusion Criteria. 
 
 
Identify inclusion criteria. 
Answering yes to any of the following questions on the clinical screening questionnaire: 
- Are you 65 years or older? 
- Have you ever smoked? 
- Do you have diabetes? 
- Do you have high blood pressure or take medication for high blood pressure? 
- Do you have high cholesterol, or take medication for high cholesterol? 
- Have you previously had a stroke? 
- Do you have heart disease? 
- Do you experience any pain at rest in your lower legs or feet? 
- Do you have discomfort (aching, fatigue, tingling, cramping or pain) when you walk, which is relieved 
by rest? Does the pain go away within 10 minutes after stopping? 
- Are your toes or feet pale, discolored, or bluish? 
- Do you have an infection, skin wound, or ulcer on your feet or toes? 
 
Identify exclusion criteria. 
- Not meeting the above criteria. 
- Previously screened with ABI in past 12 months 
 
 
i) 
Compensation. Explain the amount and schedule of compensation, if any, that will be paid for participation 
in the study. Include provisions for prorating payment. 
None 
 
 
j) 
Describe who will cover study related costs. Explain any costs that will be charged to the subject. 
SPARK Microgrant will cover cost of the digital ABI machine. 
 
Insurance carriers ordinarily would cover the costs of the ABI machine as it is being used in accordance to 
its approved use. Participants should check with their insurance companies to verify that they cover 
standard of care procedures. 
 
 
k) 
Estimate the probable duration of the entire study including data analysis and publication. This estimate 
should include the total time each subject is to be involved and the duration the data about the subject is to 
be collected. If the study is  Investigator-initiated, a timeline for individual subject recruitment, follow-up, 
total time for subject accrual, and data analysis for the study is required. 
April 10 2017- start of the project opf performing ABI 
July 10, 2017- end of project of administering digital ABI 
Dec 10, 2017 - collection of data, analysis 
Feb 10, 2018- writing manuscript/ abstact 
Patients will be in the study until their results are obtained. If they qualify for further testing, they will 
 
 
 
Page 28 of 45 

 
29 
 
PROTOCOL 
Biomedical Research 
Saint Louis University 
Protocol # 28225 
Pereira 
 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
 
 
Patients will be in the study until their results are obtained. If they qualify for further testing, they will 
receive standard of care treatment, but their records will be reviewed and information from their records 
will still be obtained. 
The digital ABI test can be complete and results available in around 5 minutes. 
 
 
--------------------------------------------------------------------------------------------- 
* * * Risks * * * 
9. Risks 
 
 
There is no research that can be considered totally risk free (e.g., a potential risk of breach of 
confidentiality). Therefore, when describing the risk, the lowest level of risk is "no more than minimal risk". 
 
 
 
Page numbers from a sponsor's protocol/grant may be referenced in 9.1, 9.2, 9.3, and 9.4. 
 
 
1. 
Use of investigational devices. Please include the clinical adverse events (AEs) associated with each 
of the devices with an indication of frequency, severity and reversibility. This information can often be 
found in the Investigator(s) brochure. NOTE: Include any likely adverse effects associated with 
procedures that subjects may experience while in the study. 
 
 
 
 
2. 
Use of investigational drugs. Please include the clinical AEs associated with each of the drugs with an 
indication of frequency, severity and reversibility. This information can often be found in the 
Investigator(s) brochure. NOTE: Include any likely adverse effects associated with placebos or 
washout periods that subjects may experience while in the study. 
 
 
 
 
3. 
Use of FDA approved drugs, reagents, chemicals, or biologic products. Please include the clinical AEs 
associated with each of the drugs with an indication of frequency, severity and reversibility. This 
information can often be found in the package insert provided by the manufacturer. NOTE: Include any 
likely adverse effects associated with placebos or washout periods that subjects may experience while 
in the study. 
 
 
 
 
4. 
Use of FDA approved devices. Please include the clinical adverse events (AEs) associated with each 
of the devices with an indication of frequency, severity and reversibility. This information can often be 
found in the Investigator(s) brochure. NOTE: Include any likely adverse effects associated with 
procedures that subjects may experience while in the study. 
Minimal discomfort from placement of the monitors on fingers 
 
 
 
 
5. 
Describe any risks related to performing study procedures. Please include all investigational, non- 
investigational, and non-invasive procedures (e.g., surgery, blood draws, treadmill tests). 
 
 
 
 
Page 29 of 45 

 
30 
 
PROTOCOL 
Biomedical Research 
Saint Louis University 
Protocol # 28225 
Pereira 
 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
 
 
 
There may be a small amount of pressure on your finger and toe where the monitor is placed this 
minor and should not be a problem. 
 
 
 
6. 
Describe any risks related to the use of radioisotopes/radiation-producing machines (e.g., X-rays, CT 
scans, fluoroscopy). 
 
 
 
 
 
7. 
Describe why this investigational compound/drug/device/procedure's risks/benefits are potentially 
better than standard of care or other common alternatives. Any standard treatment that is being 
withheld must be disclosed and the information must be included in the consent form. *?HELP?* 
The early detection of PAD is minimal compared to the problems PAD going undiagnosed could 
cause. 
 
 
 
8. 
Describe any psychological, social, or legal risks the subject may experience.  *?HELP?* 
Loss of confidentiality 
 
Page numbers from a sponsor's protocol/grant may be referenced in 9.9 and 9.10. 
 
 
9. 
Special Precautions. Describe the planned procedures for protecting against or minimizing potential 
risks. If appropriate, include the standards for termination of the participation of the individual subject. 
Discuss plans for ensuring necessary medical or professional intervention in the event of adverse 
effects to the subjects. 
All patient data will be kept in a secure locked location or on a SLU password protected database. 
 
 
10. 
Reproductive Risks. 
 
 
a. 
Please list the pregnancy category of any drugs or N/A. 
 
 
N/A 
 
 
b.  Please describe any reproductive risk associated with any part of the research study. Include any data 
from other studies (animal or human). 
none 
 
 
 
 
 
 
Page 30 of 45 

 
31 
 
PROTOCOL 
Biomedical Research 
Saint Louis University 
Protocol # 28225 
Pereira 
 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
 
11. 
Data Safety Monitoring 
Federal regulations require that when appropriate, the research protocol makes adequate provisions 
for monitoring the data to ensure the safety of participants. Monitoring should be commensurate with 
risks and with the size and complexity of the research, and could range from no plan needed to an 
independent data safety monitoring board. Please refer to SLU Guidelines for Data and Safety 
Monitoring as you complete the questions below. 
 
 
 
a. 
Is there a Data Monitoring Committee (DMC) or Board (DSMB)? 
N/A 
 
 
If yes, please provide the following information (labeled a-g): a) the composition of the board 
(degrees/qualifications of members), b)  whether the board is independent from the sponsor and 
research team or not, c)  frequency of meetings and issuance of reports to sites, d) assurance that 
the board is reviewing aggregate safety data and making recommendations regarding study 
continuance, e)  provisions for ad hoc meetings if needed, f) who is reviewing SAEs in real time (MD 
or DO), and  g)  stopping/halting rules (if any exist). 
A DSM charter can be referenced for all items except for "f) who is reviewing SAEs in real time." 
 
 
If no, please justify why not. 
 
 
 
 
 
Is there a Data Safety Monitoring Plan (DSMP)? 
N/A 
b. 
 
 
Note, if all relevant plan information is included in DSMB question above, select 'Yes' and state "see 
above" in the answer box. 
 
 
 
 
 
If yes, provide details (labeled a-e) including: a) what types of data or events are captured and how are 
they documented, b)  who is monitoring data, their independence/affiliation with the research and their 
degrees/qualifications, c)  frequency of aggregate data review, d) who is reviewing SAEs in real time 
(MD or DO), and  e)  stopping/halting rules (if any exist). 
 
 
If no, please justify why not. 
 
 
 
 
 
12. 
In case of international research (research outside of the U.S. or research on international populations 
(non-U.S.)), describe qualifications/preparations that enable you to evaluate cultural appropriateness 
and estimate/minimize risks to subjects. Include whether research is sensitive given cultural norms. 
 
 
 
 
 
Page 31 of 45 

PROTOCOL 
Protocol # 28225 
Pereira 
Biomedical Research 
Saint Louis University 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
Page 32 of 45 
 
 
32 
 
 
 
a. 
State any local laws/regulations governing Human Subjects Research in the country(ies) you will 
conduct the research and attach any relevant approvals. If none, state N/A. 
 
 
 
b. 
Will there be language barriers and if so, how will they be addressed? 
Note: If materials are to be distributed to subjects in their native language, please follow SLU's 
Guidance For Studies Involving Non-English Speaking Subjects. 
 
 
 
NOTE: Export control laws include the transfer of technical information and data, as well as information 
and technology to foreign nationals. If this study has international components, contact the SLU Export 
Control Officer for direction on whether export control policies apply. 
 
 
--------------------------------------------------------------------------------------------- 
* * * Benefits/Alternatives, Procedures to Maintain Confidentiality and Privacy * * * 
10. Benefits/Alternatives 
a) 
Benefits. Describe the potential benefit(s) to be gained by the subjects and how the results of the study 
may benefit future subjects and/or society in general. Indicate if there is no direct benefit to the 
participants. 
Early detection is critical for mitigating PAD progression. Ankle-brachial index (ABI) testing is 
recommended by the US Preventative Services Task Force as an affordable and effective screening tool 
for evaluating PAD risk. ABI testing is especially useful in primary care settings allowing for earlier 
diagnosis and treatment. Several ABI methods are used, with Doppler ABI being most common. Barriers to 
implementation include; time required to conduct tests, training and required technical skills. Hence, 
Doppler-based ABI in primary care has been limited. Participants may benefit if PAD is detected and is 
able to be treated early. 
Participants may also not receive any direct benefits. 
 
 
b) 
Alternatives. Describe any alternative treatments and procedures available to the subjects should they 
choose not to participate in the study. If no such alternatives exist, please state that the alternative is 
nonparticipation. For some studies, such as record reviews, a description of alternatives would not be 
applicable. 
Participants can choose the current standard PAD evaluation methods.This includes in hospital ABI using 
blood pressure cuffs. 
 
 
11. Procedures to Maintain Confidentiality and Privacy 
 
 
Federal regulations require that research materials be kept for a minimum of three (3) years and HIPAA 
documents be kept for a minimum of six (6) years after the closure of the study. For FDA-regulated or 
sponsored projects, the PI may be required to keep the data and documents for a longer time period. 
 
Confidentiality 

PROTOCOL 
Protocol # 28225 
Pereira 
Biomedical Research 
Saint Louis University 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
Page 33 of 45 
 
 
33 
 
 
To determine whether adequate provisions for confidentiality of data are in place, the IRB must ensure that 
research materials are stored in appropriate locations throughout the study (during collection, 
transport/transmission, analysis and long term storage). Research information must be protected using 
appropriate safeguards based on identifiability of the data and risk associated with the study (See SLU IRB 
Confidentiality Guidelines). 
 
For the questions below, please use the following definitions: 
 
&nbsp&nbsp&nbsp&nbsp&nbspAnonymous/De-identified: data contain no identifiers, including code 
numbers that investigators can link to &nbsp&nbsp&nbsp&nbsp&nbspindividual identities; 
 
&nbsp&nbsp&nbsp&nbsp&nbspCoded: data in which (1) identifying information, such as name or social 
security number, has been replaced &nbsp&nbsp&nbsp&nbsp&nbspwith a number, letter, symbol, or 
combination thereof (i.e., the code), and (2) a key to decipher the code exists 
&nbsp&nbsp&nbsp&nbsp&nbspenabling linkage of data to identifying information (e.g., a master list), and 
(3) the key (master list) is kept &nbsp&nbsp&nbsp&nbsp&nbspseparately from coded data; AND/OR 
 
&nbsp&nbsp&nbsp&nbsp&nbspIdentifiable: data that includes personal identifiers (e.g., name, social 
security number), such that &nbsp&nbsp&nbsp&nbsp&nbspinformation could be readily connected to 
respective individuals. 
 
 
 
a) 
Electronic (Computer) Data 
 
 
 
 
Click "Add" to enter data security information for each type of electronic data that will be created in the 
study: anonymous/de-identified, coded, and/or identifiable (see definitions above). 
 
To properly address this question, there should only be one listing of each type of data in the table. 
Depending on your project, you could have up to three types of data. See the SLU ITS Sensitive Data Guide 
for acceptable data security methods. 
 
Not Applicable, No Electronic (Computer) Data 
Study IRB-approved Prior to New Question (Question N/A- Grandfathered) 
 
 
Electronic Data 
 
Type of Data 
Storage Location 
Data Transmission 
Outside of SLU 
Supplemental information 
related to above items 
can be entered here or 
leave blank: 
Identifiable 
SLU ITS managed device 
(computer, tablet, etc.) 
with encryption; SLU ITS 
network storage (T: drive 
(shared drive), U: drive 
(personal drive)) 
Not Applicable, I will not 
be sending/sharing 
electronic data outside of 
SLU 

PROTOCOL 
Protocol # 28225 
Pereira 
Biomedical Research 
Saint Louis University 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
Page 34 of 45 
 
 
34 
eI B 
 
 
 
b) 
Hardcopy (Paper) Data 
 
 
 
Click "Add" to enter information for each type of hardcopy (paper) data that will be created in the study: 
anonymous/de-identified, coded, and/or identifiable (see definitions above). 
 
To properly address this question, there should only be one listing of each type of data in the table. 
Depending on your project, you could have up to three types of data. 
 
Not Applicable, No Hardcopy (Paper) Data 
Study IRB-approved Prior to New Question (Question N/A- Grandfathered) 
 
 
Hardcopy Data 
 
Type of Data 
Storage Location 
Transported Data 
Security 
Supplemental information 
related to above items 
can be entered here or 
leave blank: 
Identifiable 
SLU Locked Cabinet; 
SLU Locked Room/Office 
Personnel Supervision 
 
 
 
 
c) 
If a master list is used in this study (linking study codes to subject identifiers), explain: a) how and where 
you will secure the master list, b) how long it will be kept/when it will be destroyed, and c) provide a sample 
of the code. 
Participants hard copy forms will have Participant initials and Age and physician or nurse signature and 
date of procedure this information will be entered into EPIC in the Participants chart. 
 
 
d) 
If data or specimens are being shared outside of the research team, indicate who will receive the material, 
specifically what they will receive (data or specimens), and if an agreement has been signed to cover the 
transfer. Note: unless covered under a Clinical Trial or other agreement, the transfer of data or specimens 
to an external entity will require an agreement. For the transfer of materials (specimens), a Materials 
Transfer Agreement (MTA) is used; for the transfer of data, a Data Use or Data Transfer Agreement is 
used. Please contact the Research Innovation Group at 314-925-3027 for assistance. 
n/a 
 
 
 
 
e) 
If samples or data will be provided to SLU from an outside source, indicate whether you will have access 
to identifiers, and if so, how identifiable information is protected. Note: unless covered under another 
agreement (e.g., Clinical Trial Agreement or subcontract), the transfer of data or specimens from an 
external entity to SLU may require an agreement. For the transfer of materials (specimens), a Materials 
Transfer Agreement (MTA) may be required; for the transfer of data, a Data Use or Data Transfer 
Agreement may be required. Please contact the Research Innovation Group at 314-925-3027 for 
assistance. 

PROTOCOL 
Protocol # 28225 
Pereira 
Biomedical Research 
Saint Louis University 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
Page 35 of 45 
 
 
35 
 
 
assistance. 
n/a 
 
 
f) 
If data will be collected via e-mail or the Internet, how will anonymity or confidentiality be affected? 
Describe how  data will be recorded (i.e., will internet protocol (IP) addresses and/or e-mail addresses be 
removed from data?). 
 
 
g) 
If you will be audio/video recording or photographing subjects, provide a rationale as voiceprints and 
images of faces/unique body markings are considered identifiers. Describe confidentiality procedures, 
including any restricted access to images and/or the final disposition of the recordings/photos (destruction, 
archiving, etc.). 
 
 
 
h) 
Describe any study-specific (non standard of care) information or documentation that will be put in the 
participants' medical records for this research (e.g., study visit notes, lab results, etc.). If none, state "not 
applicable". NOTE: documentation of research in Epic should be done in accordance with the <a 
href=https://www.slu.edu/Documents/research/IRB/Epic_Research_Charting_Policy.pdf 
target=_blank>SLUCare Epic Research Charting Policy and <a 
href=https://www.slu.edu/Documents/research/IRB/Reasearch_Documentation_Epic.pdf 
target=_blank>Clinical Workflow: Documenting Research Encounters in Epic. 
Yes, ABI data will be included in the medical record. 
 
 
i) 
Are there any information security requirements identified in the project's 
N 
RFP/Award Notice/Contract? This could include data security, technical 
safeguards, security controls, NIST, FISMA, CFR, etc. 
 
If yes, SLU ITS approval is required. Contact InfoSecurityTeam@slu.edu to start 
the approval process. 
 
 
Privacy 
 
 
Privacy refers to persons having control over the sharing of oneself with others. 
 
j)  Please indicate how participant privacy will be protected in this study (select all that apply): 
 
X 
Discussion of health related and/or personal information in a private room/area 
 
X 
Research interactions/interventions are conducted in a private room/area 
 
Use of drapes or other privacy measures 
 
 
X 
Collection of sensitive/identifiable information is limited to the minimum necessary to achieve 
the aims of the research 

 
36 
 
PROTOCOL 
Biomedical Research 
Saint Louis University 
Protocol # 28225 
Pereira 
 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
 
 
X 
Access to study information is limited to the minimum amount of persons necessary to achieve 
the aims of the research (e.g., access restricted to research team members only) 
 
Consideration of parental inclusion/absence for studies involving minors 
 
Other (please explain): 
 
 
 
 
--------------------------------------------------------------------------------------------- 
* * * Potential Conflict of Interest * * * 
12. Potential Conflict of Interest 
Indicate whether you, your spouse or dependent children, have, or anticipate having, any income 
from or financial interest in a sponsor, device or drug manufacturer of this protocol, or a company 
that owns/licenses the technology being studied. Please remember that you are responding for you 
and any other investigator participating in the study. Financial Interest includes but is not limited to: 
consulting; speaking or other fees; honoraria; gifts; licensing revenues; equity interests (including 
stock, stock options, warrants, partnership and other equitable ownership interests). For questions 
regarding Conflict of Interest consult the Conflict of Interest in Research Policy. 
 
 
 
Check one of the following (please remember that you are responding for yourself, your spouse, dependent 
children and any investigator, investigator's spouse and dependent children participating in the study): 
 
 
1) 
X 
No equity interest and/or Financial Interest less than or equal to $5K 
2) 
Any equity interest and/or Financial Interest exceeding $5K but not exceeding $25K in the past 
year or expected in the current year 
3) 
Financial Interest exceeding $25K in the past year or expected in the current year 
Check all those that apply: 
Consulting 
Speaking Fees or Honoraria 
Gifts 
Licensing agreement or royalty income 
Equity interests, (including stock, stock options, warrants, partnership or equitable ownership 
interests), or serving on a scientific advisory board or board of directors 
Other fees/compensation 
 
 
 
 
If you have marked #2 or #3, please contact coi@slu.edu to initiate review of this study and provide the 
following information: 
 
 
 
 
Page 36 of 45 

PROTOCOL 
Protocol # 28225 
Pereira 
Biomedical Research 
Saint Louis University 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
Page 37 of 45 
 
 
37 
 
 
 
1. 
A Conflict of Interest Management Plan. 
has been approved for all investigators for this study 
is pending 
has not been initiated 
 
 
2. 
Describe who has, and briefly explain, the conflict of interest and indicate specific amounts for 
each subcategory checked: 
 
 
 
Note to Investigator(s) Reporting a Potential Conflict of Interest 
 
Investigator(s) must have: 
 
 
1. 
Current, up-to-date Conflict of Interest Disclosure Form on file with the SLU Conflict of Interest 
in Research Committee (COIRC) that describes any financial relationship indicated above. 
 
 
. 
This information must be disclosed on the SLU confidential Conflict of Interest 
Disclosure Form and reviewed by the COIRC before accruing research subjects in this 
study. If your current Disclosure Form does not contain this information, you are 
required to submit an updated Disclosure Form to the COIRC. 
 
 
2. 
You may not begin your study until your disclosure form has been reviewed and any required 
management plan has been approved by the COIRC for this study. To initiate COIRC review of 
your study, please contact coi@slu.edu. 
--------------------------------------------------------------------------------------------- 
* * * Informed Consent * * * 
13. Informed Consent 
 
 
Federal regulations require that informed consent be obtained from individuals prior to their participation in 
research unless the IRB grants a waiver of consent. Answer the questions, below, then click Add to provide 
the necessary consent documents and information regarding subject consent. Multiple consents/waivers 
may be added, but they must be uploaded one at a time. 
 
 
NOTE: You may refer to the SLU IRB Guidance for Obtaining Informed Consent for considerations 
regarding the consent/assent process. 
 
State N/A if not applicable. 
 
 
1) 
How is consent being obtained? When and where will the discussion take place? If the study involves 
a Non-English Speaking participant/population, please include details about plans for translated 
consent materials and interpreters to be used (see <a 
href=https://www.slu.edu/Documents/research/IRB/Non-English_Speaking_Subjects.doc 
target=_blank>SLU Guidelines for Involving Non-English Speaking Subjects for more details). 

PROTOCOL 
Protocol # 28225 
Pereira 
Biomedical Research 
Saint Louis University 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
Page 38 of 45 
 
 
38 
SU 
 
 
An informed consent will be obtained by an approved member of the research staff. 
 
The digital ABI we are offering can be performed right at the time of the patients visit to the physician 
(for the unrelated condition, e.g. Ms Mary jane visiting Dr John Doe for diabetes, but filling the 
questionnaire and needing an ABI for detecting APD). It does not involve making a new appointment 
for the test, and could save the participant time and  travel in coming another visit. The participant will 
be given ample time to review the consent form, but if he / she needs additional time, the participant 
can take it home, review it and secure an appointment for this test at another day. 
 
 
2) 
If the study involves adults unable to consent for themselves (whether diminished capacity to consent 
is temporary, permanent, progressive or fluctuating), please address the following: a) how is capacity 
to provide consent being assessed (initially and throughout study, if applicable); b) if unable to 
provide consent, how is LAR being determined (See <a 
href=https://www.slu.edu/Documents/research/IRB/LAR_Guidelines.docx target=_blank>SLU LAR 
Guidelines); c) if unable to provide consent, will assent be obtained and if not, why not?; d) if unable 
to provide assent, will dissent be honored and if not, why not? Note: participants initially unable to 
provide consent for themselves are expected to be given an opportunity to provide consent once 
capacity is gained. See <a 
href=https://www.slu.edu/Documents/research/IRB/Adults_Unable_to_Provide_Consent.docx 
target=_blank>SLU Guidelines for Adults Unable to Provide Consent for additional detail. 
n/a 
 
Note: Any assent documents which will be used per the Adults Unable to Provide Consent guidance, should be 
appropriately named and uploaded using the Add button and the Consent drop down menu selection. 
 
 
Informed Consent 
 
Title 
Consent Type 
Attached Date 
Screening Waiver of consent 
Waiver of Consent 
Approved_ no QuantFlo tracked 04- 
02-2018 
Consent 
04/26/2018 
Approved_ABI + QuantaFlo tracked 
04-02-2018 
Consent 
04/26/2018 
 
 
 
--------------------------------------------------------------------------------------------- 
* * * Assent * * * 
14. Assent 
 
 
Complete this section if your study includes minors. The Assent Form Template provides 
guidelines for writing assent documents. 
 
 
1. 
Will minors be asked to give assent, then consent once they reach adulthood? If not, please justify. If 
not capable to provide assent initially, please address whether assent will be obtained as the minor 
gains capacity. Note: children who reach the age of adulthood during participation should be given 
the opportunity to provide consent as parent/guardian consent no longer applies. If obtaining consent 
would be impracticable (e.g., this is a registry with data/specimen obtained long ago), a waiver of 

PROTOCOL 
Protocol # 28225 
Pereira 
Biomedical Research 
Saint Louis University 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
Page 39 of 45 
 
 
39 
 
 
consent should be added for IRB review. See <a 
href=https://www.slu.edu/Documents/research/IRB/Minors_in_Research.doc target=_blank>SLU 
Guidelines for Research Involving Minors for additional detail. 
 
 
 
2. 
If minors are asked to assent and do not wish to participate, will they still be accrued in the study? If 
yes, justify. 
 
 
 
3. 
How will the minor's ability to give assent be assessed? (Consider the age and maturity of the minors 
as well as their physical or mental condition). If capacity is fluctuating, please explain how capacity 
will be assessed throughout the study. 
 
 
Note: For studies that require a discussion about reproductive risks, note that the conversation with the 
minor should take place separately from the parents. Also, if a minor will reach adulthood (18 in Missouri) 
during the course of the study, they will need to be asked to consent as an adult at that time to continue in 
the study. 
 
 
 
--------------------------------------------------------------------------------------------- 
* * * HIPAA * * * 
15. HIPAA 
 
 
Studies that access, receive or collect protected health information (PHI) are subject to HIPAA regulations. 
PHI is health information with one or more personal identifiers.  For more information visit the IRB HIPAA 
page or refer to the SLU IRB HIPAA Guidance. 
 
1. Will health information be accessed, received or collected? 
No health information. HIPAA does not apply. 
X 
Yes (continue to question 2). 
 
2. Which personal identifiers will be received or collected/recorded? 
No identifiers. I certify that no identifiers from the list below will be received or collected and 
linked to health information. (Skip remainder of page). 
Limited identifiers will be received or collected/recorded (study will likely require a data use 
agreement). Select Data Use Agreement- INTERNAL or Data Use Agreement- EXTERNAL as 
appropriate, below. 
City/State/Zip codes 
Person-specific dates (e.g., date of birth, dates of service, admission/discharge dates, 
etc.) 
Age (if subjects are 90+ years) 
X 
At least one direct identifier will be received or collected/recorded. 
X 
Names 
Social Security numbers 
X 
Telephone numbers 

PROTOCOL 
Protocol # 28225 
Pereira 
Biomedical Research 
Saint Louis University 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
Page 40 of 45 
 
 
40 
 
 
Linkable code or any other unique identifying number (note this does not mean the unique 
code assigned by the Investigator(s) to code the research data) 
All geographic subdivisions smaller than a State, including street address, city, county, 
precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip 
code, if, according to the current publicly available data from the Bureau of the Census: 
(1) The geographic unit formed by combining all zip codes with the same three initial digits 
contains more than 20,000 people; and (2) The initial three digits of a zip code for all such 
geographic units containing 20,000 or fewer people is changed to 000 
X 
All elements of dates (except year) for dates directly related to an individual, including 
birth date, admission date, discharge date, date of death; and all ages over 89 and all 
elements of dates (including year) indicative of such age, except that such ages and 
elements may be aggregated into a single category of age 90 or older 
Fax numbers 
Electronic mail addresses 
X 
Medical record numbers 
X 
Health plan beneficiary numbers 
X 
Account numbers 
Certificate/license numbers 
Vehicle identifiers and serial numbers, including license plate numbers 
Device identifiers and serial numbers 
Web Universal Resource Locations (URLs) 
Internet Protocol (IP) address numbers 
Biometric identifiers, including finger and voice prints 
Full face photographic images and any comparable images 
 
 
If you are receiving or collecting/recording health information and at least one personal identifier, please 
continue to complete the sections, below. 
 
3. Sources of Protected Health Information: 
X 
Hospital/medical records for in or out patients 
X 
Physician/clinic records 
X 
Laboratory, pathology and/or radiology results 
Biological samples 
Interviews or questionnaires/health histories 
Mental health records 
Data previously collected for research purposes 
Billing records 
Other 
Please describe: 
 
 
 
4. If data will be shared outside the research team and the study involves PHI indicate how the research 
team will share the information. 

PROTOCOL 
Protocol # 28225 
Pereira 
Biomedical Research 
Saint Louis University 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
Page 41 of 45 
 
 
41 
eIRB 
 
 
 
X 
Not applicable (continue to question 5). 
Only linkable code that can link data to the identity of the subject. A code access agreement or 
business associate agreement may be needed when data are shared with other non-SLU 
entities. If necessary, the agreement can be added and uploaded in item #5, below. 
Limited identifiers: Zip codes, dates of birth, or other dates only. The study qualifies as a Limited 
Data Set. A data use agreement may be needed when data are shared with other non-SLU 
entities. If necessary, the agreement can be added and uploaded in item #5, below, using DUA- 
external option. 
With unlimited identifiers. The consent document and HIPAA Authorization form must describe 
how the information will be disclosed. 
 
 
5. HIPAA Documentation is required for this study. Use the table below to add HIPAA Documents for 
your study. 
 
 
 
HIPAA Documents 
 
HIPAA Documents 
Title 
Attached Date 
Waiver of Authorization 
Waiver of Authorization 
HIPAA Authorization 
Approved_28225 marked HIPAA 
Version 2 
04/26/2017 
 
 
 
--------------------------------------------------------------------------------------------- 
* * * Attachments * * * 
16. Attachments 
 
In this section, please upload additional documents associated with your protocol. Failure to attach files 
associated with the protocol may result in the protocol being returned to you. 
 
 
Possible documents for this protocol could include: 
• 
Bibliography 
• 
Cooperating Institution's IRB Approval 
• 
Data Collection Sheet 
• 
Debriefing Script 
• 
Device Information/Documentation 
• 
Grant Proposal/Sub-Contract 
• 
Human Subjects Training Certificate/Proof of Training 
• 
Information Sheet/Brochure 
• 
Interview/Focus Group Questions 
• 
Investigator's Brochure 

PROTOCOL 
Protocol # 28225 
Pereira 
Biomedical Research 
Saint Louis University 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
Page 42 of 45 
 
 
42 
eI B 
 
 
• 
Letter of Agreement/Cooperation 
• 
IND Application Letter 
• 
Package Insert 
• 
Patient Diary Form 
• 
Questionnaire/Survey 
• 
Recruitment Material (e.g., flyers, ads, e-mail text) 
• 
Safety Information (DSM Information) 
• 
Scientific/PPC Review or Department Chair Review 
• 
Sponsor's Protocol 
• 
Sponsor's Protocol Amendment 
• 
Study Design Chart/Table 
• 
Other files associated with the protocol (most standard formats accepted: pdf, jpg, tiff, mp3, wmv, 
etc.) 
 
 
To update or revise any attachments, please delete the existing attachment and upload the revised 
document to replace it. 
 
Document Type 
Document Name 
Attached Date 
Submitted Date 
Other 
Spark Microgrant_Pereira 03/21/2017 
03/29/2017 
Bibliography 
References 
03/22/2017 
03/29/2017 
Package Insert 
35-0076.A-QuantaFlo- 
User-Manual1 
03/24/2017 
03/29/2017 
Device 
Information/Documentatio 
n 
Quantaflow 510k 
approval 
03/24/2017 
03/29/2017 
Device 
Information/Documentatio 
n 
Quantaflow 510k 
03/24/2017 
03/29/2017 
Grant Proposal/Sub- 
Contract 
Spark Microgrant 
approval letter from ORS 
03/24/2017 
03/29/2017 
Data Collection Sheet 
Approved_Data sheet 
04/26/2017 
04/26/2017 
Recruitment Material 
(e.g., flyers, ads, e-mail 
text) 
Approved_ABI poster 
Version 3 
05/02/2017 
05/02/2017 
 
 
 
--------------------------------------------------------------------------------------------- 
* * * PI Obligations * * * 
 
 
PI Obligations 
 
 
By clicking the box  below you indicate that you accept responsibility for and will follow the ethical guidelines set 
forth by the Belmont Report, Declaration of Helsinki, the Nuremberg Code, and the Ethical Principles of the 
American Psychological Association (if applicable) for the research described. It also indicates that you have the 

PROTOCOL 
Protocol # 28225 
Pereira 
Biomedical Research 
Saint Louis University 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
Page 43 of 45 
 
 
43 
 
 
American Psychological Association (if applicable) for the research described. It also indicates that you have the 
requisite funding, credentials, training, and any necessary hospital privileges, if needed, to carry out all 
procedures and treatments involved in the protocol. 
 
 
Clicking the box  also affirms that the activities involving human subjects will not begin without prior review and 
approval by the Institutional Review Board, and that all activities will be performed in accordance with state and 
federal regulations and Saint Louis University's assurance with the Department of Health and Human Services. 
The PI assures that if members of the SLU research team access protected health information (PHI) from a 
covered entity in order to seek consent/authorization for research or to conduct research, such access is 
necessary for the research, is solely for that purpose, and the information will not be removed from the covered 
entity without IRB authorization or approved waiver. PI further assures that the SLU research team will comply 
with the terms of a Data Use Agreement to PHI (if any). 
1) 
Have you completed the annual Conflict of Interest in Research Disclosure Form? 
Y 
You can only select N/A if you are not currently listed on any externally 
funded research projects nor listed on any proposals 
for externally funded research support. 
 
 
 
 
NOTE: An annual disclosure must be completed by all faculty, staff and students involved in the design, 
conduct or reporting of externally funded research applications and awards. 
 
 
 
 
2) 
Have your financial interests changed significantly since you completed the annual 
N 
disclosure form? 
 
 
 
The PRINCIPAL INVESTIGATOR certifies that he/she has read the University's Conflict of Interest Research 
Policy and has checked the appropriate box in the 'Potential Conflict of Interest' section of the application. In 
addition, the PRINCIPAL INVESTIGATOR certifies that, to the best of his/her knowledge, no person working on 
this project at SLU has a conflict of interest or if a conflict of interest does exist, that an appropriate management 
plan is in place. 
 
 
According to the Saint Louis University Conflict of Interest in Research Policy, as PI, it is your responsibility to 
inform co-investigators, staff, or students involved in the design, conduct, or reporting of externally sponsored 
research of their requirement to complete a Conflict of Interest in Research Disclosure Form. 
 
X 
I accept this responsibility. 
 
 
 
X 
The Principal Investigator has read and agrees to the above certifications and will abide 
by the above obligations. 
--------------------------------------------------------------------------------------------- 

 
44 
 
PROTOCOL 
Biomedical Research 
Saint Louis University 
Protocol # 28225 
Pereira 
 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
 
 
 
* * * Event History * * * 
 
Event History 
 
Date 
Status 
View Attachments 
Letters 
05/07/2018 
REPORT 2 FORM 
Y 
Y 
APPROVED 
04/26/2018 
CONTINUING REVIEW 1 
Y 
Y 
FORM APPROVED 
04/26/2018 
PROTOCOL EXPIRED 
04/20/2018 
REPORT 2 FORM 
REVIEWER(S) ASSIGNED 
04/19/2018 
REPORT 2 FORM PANEL 
MANAGER REVIEW 
04/19/2018 
CONTINUING REVIEW 1 
FORM REVIEWER(S) 
ASSIGNED 
04/19/2018 
REPORT 2 FORM PANEL 
REASSIGNED 
04/17/2018 
REPORT 2 FORM 
Y 
SUBMITTED (CYCLE 1) 
04/09/2018 
REPORT 2 FORM 
REVIEWER(S) ASSIGNED 
04/04/2018 
CONTINUING REVIEW 1 
Y 
FORM SUBMITTED 
04/02/2018 
REPORT 2 FORM 
Y 
SUBMITTED 
04/02/2018 
REPORT 2 FORM CREATED 
03/27/2018 
CONTINUING REVIEW 1 
FORM CREATED 
11/06/2017 
AMENDMENT 5 FORM 
Y 
Y 
APPROVED 
11/04/2017 
AMENDMENT 5 FORM 
REVIEWER(S) ASSIGNED 
10/27/2017 
AMENDMENT 5 FORM 
Y 
SUBMITTED 
09/18/2017 
AMENDMENT 5 FORM 
CREATED 
06/08/2017 
AMENDMENT 4 FORM 
Y 
Y 
APPROVED 
06/07/2017 
AMENDMENT 4 FORM 
REVIEWER(S) ASSIGNED 
06/06/2017 
AMENDMENT 4 FORM 
Y 
SUBMITTED 
06/06/2017 
AMENDMENT 4 FORM 
CREATED 
 
 
 
 
Page 44 of 45 

 
45 
 
PROTOCOL 
Biomedical Research 
Saint Louis University 
Protocol # 28225 
Pereira 
 
Protocol Title: 
Sensitivity and specificity of digital ankle brachial index (ABI) as a screening tool in 
detecting peripheral arterial disease: A single center, prospective clinical trial 
---------------------------------------------------------------------------------------------------- 
 
 
05/30/2017 
AMENDMENT 3 FORM 
Y 
Y 
APPROVED 
05/30/2017 
AMENDMENT 3 FORM 
REVIEWER(S) ASSIGNED 
05/27/2017 
AMENDMENT 3 FORM 
Y 
SUBMITTED 
05/27/2017 
AMENDMENT 3 FORM 
CREATED 
05/17/2017 
AMENDMENT 2 FORM 
Y 
Y 
APPROVED 
05/16/2017 
AMENDMENT 2 FORM 
REVIEWER(S) ASSIGNED 
05/16/2017 
AMENDMENT 2 FORM 
Y 
SUBMITTED 
05/16/2017 
AMENDMENT 2 FORM 
CREATED 
05/16/2017 
REPORT 1 FORM CREATED 
05/02/2017 
AMENDMENT 1 FORM 
Y 
Y 
APPROVED 
05/02/2017 
AMENDMENT 1 FORM 
REVIEWER(S) ASSIGNED 
04/28/2017 
AMENDMENT 1 FORM 
Y 
SUBMITTED 
04/28/2017 
AMENDMENT 1 FORM 
CREATED 
04/26/2017 
NEW FORM APPROVED 
Y 
Y 
04/26/2017 
NEW FORM REVIEWER(S) 
ASSIGNED 
04/13/2017 
NEW FORM REVIEWER(S) 
ASSIGNED 
03/30/2017 
NEW FORM PANEL 
ASSIGNED 
03/29/2017 
NEW FORM SUBMITTED 
Y 
03/29/2017 
NEW FORM PREREVIEWED 
03/29/2017 
NEW FORM PREAPPROVAL 
03/21/2017 
NEW FORM CREATED 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Page 45 of 45