Orthofeet: A Prospective Proof of Concept Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Pain Relief Footwear
Phase: PHASE1
Conditions: Foot Pain
Sponsor: Bijan Najafi, PhD

 
 
Institutional Review Board for Baylor College of Medicine and Affiliated
Hospitals
 
Protocol Number:    H-51229
Status:                        Approved
Initial Submit Date:  1/27/2022
Approval Period:       6/15/2022 - 6/14/2027
 
Section Aa:  Title & PI
A1.  Main Title
     ORTHOFEET: A PROSPECTIVE PROOF OF CONCEPT TRIAL TO EVALUATE EFFICACY, ACCEPTABILITY, AND
PERCEPTION OF BENEFIT OF AN INNOVATIVE PAIN RELIEF FOOTWEAR
A2.  Principal Investigator
 
     Name:  
BIJAN NAJAFI
Phone:  
7137987536
     Id:  
191680
Fax:  
     Department:   SURGERY: VASCULAR SURGERY DIV.
Email:   
najafi@bcm.edu
     Center:  
Mail Stn:   BCM390
A3.  Administrative Contact
 
     Name:
MARIA NOUN
Phone:  
7137987537
     Id:  
204533
Fax:  
     
Email:   
noun@bcm.edu
     
Mail Stn:   BCM390
A3a.  Financial Conflict of Interest
Does any member of study personnel (Investigator (including investigator's spouse and/or dependent children)) that are
involved in the design, conduct, or reporting of the research have a Significant Financial Interest (SFI) that would reasonably
appear to be affected by the research for which funding is sought and/or associated with an entity/business that would
reasonably appear to be affected by the research?
          No
 
Section Ab:  General Information    
A4.  Co-Investigators
 
     Name:  
ANMOL MOMIN
Phone:  
7137987536
Id:  
202019
Fax:  
Department:   SURGERY: SURGICAL ONCOLOGY
Email:   
anmolm@bcm.edu
Center:  
Mail Stn:   BCM390
 
     Name:  
NESREEN EL-REFAEI
Phone:  
Id:  
237388
Fax:  
Department:   SURGERY: SURGICAL ONCOLOGY
Email:   
u237388@bcm.edu
Center:  
Mail Stn:  
A5.  Funding Source:
     Baylor College of Medicine (Internal Funding Only)
A5a. Associated ESP2 funding proposal linked to this protocol:
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A6a.  Institution(s) where work will be performed:
     BCM: Baylor College of Medicine
Baylor St. Luke's Medical Center (BSLMC)
A6b.  Research conducted outside of the United States:
     
Country:  
Facility/Institution:  
Contact/Investigator:  
Phone Number:  
If documentation of assurances has not been sent to the Office of Research, please explain:
A7.  Research Category:
     
A8. Therapeutic Intent
Does this trial have therapeutic intent?
     No
 
A9. ClinicalTrials.gov Registration
Does this protocol/trial require registration on ClinicalTrials.gov due to it: meeting the definition of an Applicable Clinical Trial,
being required under the terms and conditions of an award, or being proposed to be published in ICMJE journals?
     
No, this clinical is not a clinical trial, or does not meet the definition of an Applicable Clinical Trial, or does not need to be
registered under the terms and conditions of an award, or is not a clinical trial with results intended to be reported in an
journal belonging to the ICMJE. Registration is not required.
 
Section B:  Exempt Request
B.  Exempt From IRB Review
     Not Applicable
 
Section C:  Background Information
     It has been estimated that approximately 10% of people will experience foot pain in their lifetime, resulting in approximately
600,000 outpatient visits annually. The economic burden of plantar fasciitis in 2007 was estimated to be $192 million to
$376 million indirect costs. Few studies including ours (Wrobel et al, JAPMA, 2015) suggested that orthoses provide short-,
intermediate-, and long-term benefits for decreasing pain and improving function in plantar fasciitis. However, the
acceptability of conventional orthoses is limited and often are costly. Furthermore, very few studies explored the benefits of
footwear intervention in improving function including daily physical activities, gait, and balance.
Objective assessment of pain and function are important outcome measures for foot-related pathology. While conventional
self-reported health-related quality-of-life instrument that measures a patient's physical, mental, and social wellbeing
demonstrated that self-reported physical function disability from plantar fasciitis, this assessment may not be sensitive
enough to detect changes over time in specific disease states or in response to treatment. Moreover, the responsiveness
of these measures to detect important clinical changes has recently been called into question with the use of activity
monitors. These assessments rely on self-reporting and recall and, therefore, are subjective and prone to biases. In
addition, they may not be accurate in older adults or patients with cognitive decline. Furthermore, they often fail to capture
the dynamic nature of pain and its effect on activities of daily living. Recent advances in wearable technologies open new
opportunities to evaluate fine-grain information about patients' activity patterns and behavior and thus provide a better
picture of the benefit of pain relief on function and daily physical activities in a natural condition outside of gait laboratories.
Results from recent studies suggest that these objective measurements may represent the functional weight-bearing
capacity of an individual in detecting important clinical changes due to pain management.
Therefore, the purpose of this prospective proof of concept study is to examine the effectiveness of a new pain relief
footwear (Orthofeet) on function and daily activities over short (one week) and intermediate (4 weeks). We hypothesize
that ortho feet will reduce foot pain leading to an increase in daily physical activities, measured objectives using validated
wearables (PAMSys and Garmin wristwatch), and functional performance (gait and balance). In addition, we hypothesis
that reduction in foot pain is associated with reduced physiological stress response (HRV) and better community
engagement (assessed by life space questionnaire).
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The Orthofeet shoes were first created in 1984 by engineers to combine attractive footwear styling with innovative
therapeutic features. The shoes contains anatomical orthotic insoles that have helped millions of users improve mobility,
enhance comfort from heel to toe, and get relief of heel, foot, knee, and lower pain. The insoles provide arch support with
super cushioning with a mild rocker design. The shoes may reduce pressure under the heel and soften your step while you
walk.
 
Section D:  Purpose and Objectives
     
The purpose of this prospective proof of concept study is to examine effectiveness of a new pain relief footwear (Orthofeet)
on function and daily activities over short (one week) and intermediate (6 weeks). We hypothesize a reduction in foot pain
might lead to an increase in daily physical activities, measured objective using validated wearables (PAMSys and Garmin
wrist watch) and functional performance (gait and balance). In addition, we hypothesis that reduction in foot pain is
associated with reduced physiological stress response (HRV) and better community engagement (assessed by life space
questionnaire).
 
Section E:  Protocol Risks/Subjects
E1.  Risk Category
     Category 1: Research not involving greater than minimum risk.
E2.  Subjects
Gender:
     Both
Age:
     Adult (18-64 yrs), Geriatric (65+ yrs)
Ethnicity:
     All Ethnicities
Primary Language:
     English
Groups to be recruited will include:
     Patients
Which if any of the following vulnerable populations will be recruited as subjects?
     
Vulnerable populations require special protections.  How will you obtain informed consent, protect subject confidentiality, and
prevent undue coercion?
     
E3.  Pregnant woman/fetus
Will pregnant women and/or fetuses (as described in 45 CFR 46 Subpart B) be enrolled in the research?
     No
E4.  Neonates
Will neonates of uncertain viability or nonviable neonates (as described in 45 CFR 46 Subpart B) be enrolled in the research?
     No
E5.  Children
Will children be enrolled in the research?
     No
 
Section F:  Design/Procedure
F1.  Design
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Select one category that most adequately describes your research:
     c) Pilot
Discuss the research design including but not limited to such issues as: probability of group assignment, potential for subject
to be randomized to placebo group, use of control subjects, etc.
     
The study will be performed at the Baylor College of Medicine. Approval from Site Review Authority will be obtained.
Subjects will be recruited from outpatient clinics at Baylor College of Medicine.
We propose a randomized crossover trial (Phase I/II) to evaluate acceptability as well as short (1 week) and intermediate
(6week) benefits and effectiveness of Orthofeet in reducing foot pain, increasing daily physical activities, and improving
functional performance in ambulatory patients suffering from foot pain.
We are proposing a clinical study at the Baylor College of Medicine, to evaluate short and intermediate benefits and
effectiveness of a novel pain relief footwear, called Orthofeet. This is a randomized crossed over trial. The duration of the
study would be 12-week. We will recruit 50 eligible ambulatory adults (age 50 years or older) with moderate to severe self-
reported foot pain. Participants will be randomly assigned to Group A (25 subjects) and Group B (25 subjects). There is no
difference in assessments or eligibility between Group A and Group B, the only difference is when they have the
opportunity to try the shoes for 6 weeks. Group A will receive a pair of Orthofeet shoes with adjustable insoles and will be
asked to wear it every day activities of daily living for duration of six weeks. Participants will be also encourage to wear the
shoes inside of home if possible. Group B will be followed for duration of six weeks. At six weeks the groups will be
switched and group B will receive and a pair of Orthofeet shoes with adjustable insoles and Group B will follow-up for six
week without Orthofeet shoes. Participants will be assessed at baseline, week-1, week-6, week 7, and week 12.
The primary outcome includes changes compared to baseline in foot pain intensity.
The secondary outcomes includes changes compared to baseline in various metrics of daily physical activities (e.g., daily
step, longest walking bout, cadence, standing duration, and standing duration).
Other outcomes include gait parameters (e.g., gait speed, gait steadiness, gait variability, double stance, and limp
assessed using a validated wearable gait analyzer), static balance (assessed using a validated wearable balance
assessment system), acceptability and perception of benefit (assessed by technology acceptance model), adherence
(daily duration of wearing orthofeet), physiological stress response (e.g., heart rate variability, HRV, rest heart rate, HR-rest
assessed by a wrist worn sensor), community engagement (life space assessed by a questionnaire). Standard
questionnaires and assessments will be performed to evaluate subject¿s perception of benefit, user-friendliness,
satisfaction, adherence, pain, sleep quality, concerns for fall, frailty, moving ability, risk of falling, anxiety, and quality of life.
Resources available to conduct the Human Research
The PI is a Professor of Surgery at the Baylor College of Medicine and has been involved in multiple clinical trials along
with numerous publications in the area of outcomes evaluation, foot care, pain management, physical activity monitoring,
gait and balance assessments in relation to diseases such as diabetes, cancer, plantar fasciitis, and aging population.
Other team members include biomedical engineers/research scientists and study coordinators who are well acquainted
with the study site, culture, and society. The wearable sensor technology is available at our center (iCAMP) for this study
and includes LegSys (to assess Spatio-temporal parameters of gait), BalanSens (to assess postural control) and PAMSys
(to monitor daily physical activity pattern and behavior), and Garmin (to assess daily physical activities and physiological
stress response). All persons assisting with the study have received appropriate training and are extremely knowledgeable
in their study-related duties and functions.
Inclusion Criteria:
     50 total subjects will be recruited. Those eligible will meet the following inclusion criteria: Male or female 50 years or older
Self-reported foot pain including heel, arch, or ball of foot pain
Exclusion Criteria:
     
Exclusion criteria: Patients with plantar ulcer Patients with major foot deformity (e.g., Charcot foot, Pes Cavus) Patients
with lower extremity amputation including minor amputation. Foot pain because of nail disorder or keratotic lesions (e.g.
corns, calluses) Patients with unstable conditions (e.g., recent stroke, anticipated changes in medication regime) Acute
fractures of the foot Participation in an interventional Study such as exercise intervention within the last 30 days Non-
ambulatory or unable to stand without help or walk a distance of at least 6 feet without assistance. Patients with major
cognitive impairment or major depression Patients who are unable or unwilling to participate in all procedures and follow
up evaluations
F2.  Procedure
     7) The research will be conducted at the following location(s): Baylor College of Medicine and Baylor St. Luke's Medical
Center (BSLMC). Duration of study: 12 weeks
Research staff may contact you for any study related questions throughout your participation in the study
Visit 1 (Baseline): Maximum duration 120 minutes
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Screening: Measurements will take place at your home, or in Baylor Clinic based on your preference. Participants will be
randomly placed in either Group A or Group B. Group A wears the OrthoFeet shoes from baseline to 6 week follow up and
Group B wears OrthoFeet shoes from 6 week follow up to 12 week follow up.
All the same assessments and questionnaires are completed at each visit for all participants.
Foot Pain: Foot pain will be assessed by the revised Foot Function Index (FFI). FFI was developed in 1991 to measure the
impact of foot pathology on function in terms of pain, disability, and activity restriction. It is a self-administered index
consisting of 23 items divided into 3 sub-scales. Both total and sub-scale scores are produced. The FFI has been shown to
be a reasonable tool for use with low functioning individuals with foot disorders, patients with rheumatoid arthritis, and non-
traumatic foot or ankle problems. It can be used in both clinical and research settings. Foot pain will be assessed at
baseline, week-1, week-6, week-7, and week-12.
Postural Balance test: will be assessed in double stance and semi-tandem stance while subjects stand straight with hands
crossed around the chest for up to 30 seconds with eyes open and closed. Gait assessments: A validated and FDA-
approved wearable platform (LEGSysTM, Biosensics LLC) will be used to assess gait. Gait will be assessed over a
distance of 20m using LEGSys¿, which uses five inertial measurement units attached to the anterior of each shin and,
thigh, and posteriorly to the lower back. The system estimates spatiotemporal gait parameters such as stride velocity,
stride length, stride time, double support, single support, and stride-to-stride variability, and gait initiation. In addition, the
COM range of motion during walking will be calculated based on the data from the sensor attached to the lower back. Gait
will be assessed under habitual speed and walking at maximum speed during a single task and dual-task condition.
Activities of daily living: ADL will be monitored using a validated pendant sensor (PamSysTM) during a period of one week
at baseline (week-1) and week-6, and week-12. We used our validated algorithms to determine postures (lying, sitting, and
standing postures), walking parameters (cadence, longest walking bout, total steps per day), sleep (time in bed, sleep
efficacy, sleep onset latency), and activity behavior (sedentary, light, and moderate to vigorous activity) of each patient to
monitor their performance. The algorithm for activity monitoring has been validated against direct observation, motion
tracking system, as well as the patient diary. The algorithm for monitoring sleep was validated against Polysomnography
and actigraphy in a sleep lab. The day-to-day reliability was also demonstrated in the geriatric population. In addition, we
will use a Garmin wristwatch to track physiological stress response, daily activities, and sleep quality during the entire
duration of the study. A pre-paid envelop will be provided to collect the sensor.
Quality of life and mobility: Health-related quality of life will be assessed using the Functional Assessment of Cancer
Therapy ¿ General (FACT-G) survey. General (FACT-G) is a 27-item questionnaire designed to measure four domains of
quality of life: Physical, social, emotional, and functional well-being. Quality of life and mobility will be assessed at baseline,
week 6 and week 12.
Patient acceptability: We will use a Technology Acceptance Model (TAM) survey adapted for footwear to determine
perceived benefit, perceived ease of use, acceptability, and attitude toward daily use. Patient acceptability will be assessed
at the end of week 6 active use of OrthoFeet (6- week for Group A and 12 week for group B) or the conclusion of the study
for early endpoint.
Ancillary Measurements Patient-reported outcomes: Self-reported pain level will be extracted from FACT-G; ADL will be
assessed using Katz Index of Independence in ADL; Community engagement will be assessed using the Life-Space
Assessment questionnaire; The Fall Efficacy Scale-International (FES-I) questionnaire to determine concern for falls.
Anxiety will be assessed using the Beck Anxiety Inventory questionnaire; cognition will be assessed using Montreal
Cognitive Assessment (MoCA). Patient-reported outcomes will be assessed at baseline, week 6 and week 12. The
subjects will not be advised or counseled based on the results of the questionnaires, these tools are not diagnostic, but the
coordinators will try to provide possible resources if asked by the subject.
Digital Photographs ¿may take digital photographs of the subjects while performing exercise or during assessments for the
purpose of publication (conferences/manuscripts). Physical frailty: Frailty will be assessed by trauma-specific frailty index
and a validated wearable frailty meter technology.
Health related questionnaires: A series of health related questionnaires will be used to evaluate your quality of life , fear of
falling, fall history, mobility, activities of daily living, depression, frailty, mental exams, foot examinations, pain intensity
levels. Your medical history (from your clinic chart such as: medication use, prior surgery, diagnosis, progress notes, etc.)
and demographic information will be obtained, such as age, gender, weight, and height. These questionnaires are asked to
review the subject holistically and assess changes in their overall health, including mental and physical, over the 3 month
span. The relevance to foot pain is to see how these components of health are related to foot pain such as finding a
connection between their foot pain and fear of falling doing different activities.
At Visit 2 (1 Week Follow Up) the participant is called by the research staff to complete the pain questionnaire, document
adverse events, and answer any study-related questions.
At Visit 3 (6 Week Follow Up) the participant will complete all the same assessments and questionnaires as baseline. At
this visit, Group A will stop wearing OrthoFeet shoes and continue the study without them. Group B will be supplied with
OrthoFeet shoes to wear for the rest of their study participation until 12 Week Follow Up.
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At Visit 4 (7 Week Follow Up) the participant is called by the research staff to complete the pain questionnaire, document
adverse events, and answer any study-related questions.
At Visit 5 (12 Week Follow Up) the participant will complete all the same assessments and questionnaires as baseline. All
participants will return OrthoFeet shoes by this point.
 
Section G:  Sample Size/Data Analysis
G1.  Sample Size
How many subjects (or specimens, or charts) will be used in this study?
     Local: 50              Worldwide: 50
Please indicate why you chose the sample size proposed:
     
This is a proof of concept study. The sample size is 50 eligible participating in a randomized crossover study. The sample
size is convenient and is selected to detect a between group difference for the primary outcome (change in foot pain) with
medium effect size (Cohen¿s d=0.50) with a dropout rate of 15%, alpha of 5%, and power of 80%. The anticipated effect
size was estimated from our prior study (Najafi et al, Journal of Foot and Ankle Research, 2014) in which we observed a
significant drop in foot pain after orthotic therapy compared to sham orthotics. Based on this pilot study, we will propose a
Phase II study to validate the observed effect in the follow-up study.
G2.  Data Analysis
Provide a description of your plan for data analysis. State the types of comparisons you plan (e.g. comparison of means,
comparison of proportions, regressions, analysis of variance). Which is the PRIMARY comparison/analysis? How will the
analyses proposed relate to the primary purposes of your study?
     
We will utilize REDCap, a HIPAA compliant database application, to ensure uniformity of data entry. A qualified postdoc will
provide ongoing oversight and reporting of data quality, including missing data, timeliness of data entry, responsiveness to
data queries, etc. Data meetings will be held twice monthly, and specific challenges will be addressed. Baseline descriptive
statistics among randomized groups will include demographic and clinical variables, summarized as mean (SD) (or
median, IQR) for continuous variables and frequency (percent) for categorical variables. For each baseline variable, the
magnitude of group differences will be summarized as pairwise standardized mean/proportion differences (group
difference divided by SD). Distributions of continuous trial outcomes will be evaluated for normality; normalizing
transformations will be completed if needed. Group comparisons on primary outcomes will be by intent to treat. Statistical
testing on the outcomes will be evaluated at alpha=0.05 each. Group comparisons on secondary and exploratory
outcomes will control for multiple comparisons (false discovery rate) using the Benjamini-Hochberg method. In all models,
outcomes will be summarized as mean group levels (with 95% CI) and mean group differences (with 95% CI). Results of
the user experience questionnaires will be calculated as median (range) for each Likert-scale question. Unpaired t-tests,
Mann-Whitney u-tests, and Chi-square will be used for baseline between groups comparison to verify effectiveness of
randomization. To evaluate the effect of gender as biological variable, we will examine whether acceptability and benefits
of footwear (between groups as well as compared to baseline) are different between men and women.
 
Section H:  Potential Risks/Discomforts
H1.  Potential Risks/Discomforts
Describe and assess any potential risks/discomforts; (physical, psychological, social, legal, or other) and assess the likelihood
and seriousness of such risks:
     
The risk to participants of this study is considered to be minimal in a controlled environment with an attendant present. This
research routine will not place subjects at higher risk than normal activities of daily living, and no more risk of harm or
discomfort is associated with these tests than the discomfort normally incurred while performing normal activities.
Subjects may experience mild discomfort from the shoe. We will inform the subject to please notify the investigators if the
shoe is uncomfortable.
Should the subject agree to the assessment involving the wearable sensor (PAMSys), the potential risks are considered
minimal as well. This sensor will be used for assessing mobility performance and will perform physical tasks such as
walking, sit-to-stand transitions, standing, physical activity monitoring etc. These assessments are non-invasive, safe, non-
toxic, and non-ionizing as the other procedures described in this study. However, like any battery powered systems, there
is a minimum risk of sensor malfunctioning. In addition, the study devices are not waterproof, and although they use a low
powered battery (similar to a cellphone battery), in order to avoid any risk of shock the monitor should not be submerged or
saturated with fluids during operations or cleaning. It does not emit any radiation to the human body, and does not offer
any significant risk to the subject. The wearable sensors weigh less than .25 kg.
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H2.  Data and safety monitoring plan
     Do the study activities impart greater than minimal risk to subjects?
          No
H3.  Coordination of information among sites for multi-site research
Is the BCM Principal Investigator acting as the SPONSOR-INVESTIGATOR for this multi-site research?
          No or Not Applicable
Is BCM the COORDINATING CENTER for this multi-site research?
          No or Not Applicable
 
Section I:  Potential Benefits
Describe potential benefit(s) to be gained by the individual subject as a result of participating in the planned work.
     Characterize the impact of OrthoFeet on foot pain
Describe potential benefit(s) to society of the planned work.
     Characterize the feasibility of the OrthoFeet device on patient adherence, acceptability, user-friendliness, and perception of
benefit for daily usage
Do anticipated benefits outweigh potential risks? Discuss the risk-to-benefit ratio.
     This study brings no more than minimal risk to subjects as it only involves a non-invasive device. There are some risks
associated with lack of comfort.
 
Section J:  Consent Procedures
J1.  Waiver of Consent
Will any portion of this research require a waiver of consent and authorization?
     No
 
J1a.  Waiver of requirement for written documentation of Consent
Will this research require a waiver of the requirement for written documentation of informed consent?
     No
J2.  Consent Procedures
Who will recruit subjects for this study?
     PI
PI's staff
Describe how research population will be identified, recruitment procedures, any waiting period between informing the
prospective participant and obtaining consent, steps taken to minimize the possibility of coercion or undue influence and
consent procedures in detail.
     Participants will be recruited based on referral from their clinician or through recruitment flyers placed in Baylor Clinic. The
eligible subject will contact us or be approached by the research personnel after being referred by the clinical physician
and his clinical staff (part of the research team). The subject will be fully informed about the study, and should voluntarily
agree to participate with the guidelines as stipulated in the informed consent. The study coordinator or designee will
introduce the study, present the written consent form, and spend as much time as necessary to ensure the potential
subject completely understands the protocol. Emphasis will be placed on the voluntary nature of participation and the
subject will be assured that his/her care will not be compromised in any way whether or not they choose to participate. The
subject will be informed s/he can withdraw from the study at any time without loss of benefits. Consent forms will then be
signed and dated by the subject and individual obtaining consent (PI, co-PI, study coordinator, or designee). Once written
consent is obtained, the protocol may begin immediately or a follow-up appointment may be made. The individual (PI, co-
PI, study coordinator, or designee ¿ interns) obtaining consent will be given a thorough training of the process and go
through several mock consent scenarios. The consent training consists of understanding the study and being able to fully
explain it to the participant providing all pertinent information (procedures, risks, benefits, alternatives to participant), giving
sufficient time to the participant to consider whether or not they would like to participate, and answer any questions which
the subject may have. The training will have a strong emphasis on subject comprehension of the research study by asking
open-ended questions to the subject.
The original documents (with signature) will be maintained per IRB policy. Any critical information will be sent for inclusion
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in the medical records, if it affects patient¿s wellbeing and any future treatment. A copy of signed consent form will be
offered to the patient for personal records. Informed consent will be obtained prior to performance of any study procedures.
Are foreign language consent forms required for this protocol?
     No
J3.  Privacy and Intrusiveness
Will the research involve observation or intrusion in situations where the subjects would normally have an expectation of
privacy?
     No
J4.  Children
Will children be enrolled in the research?
     No
J5.  Neonates
Will non-viable neonates or neonates of uncertain viability be involved in research?
     No
J6.  Consent Capacity - Adults who lack capacity
Will Adult subjects who lack the capacity to give informed consent be enrolled in the research?
     No
J7.  Prisoners
Will Prisoners be enrolled in the research?
     No
 
Section K:  Research Related Health Information and Confidentiality
Will research data include identifiable subject information?
     Yes
Information from health records such as diagnoses, progress notes, medications, lab or radiology findings, etc.
     Yes
Specific information concerning alcohol abuse:
     No
Specific information concerning drug abuse:
     No
Specific information concerning sickle cell anemia:
     No
Specific information concerning HIV:
     No
Specific information concerning psychiatry notes:
     No
Demographic information (name, D.O.B., age, gender, race, etc.):
     Yes
Full Social Security #:
     Yes
Partial Social Security # (Last four digits):
     No
Billing or financial records:
     No
Photographs, videotapes, and/or audiotapes of you:
     Yes
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Identifiable biospecimens
     No
Other:
     No
At what institution will the physical research data be kept?
     The physical research will be kept in our BCM offices housed in the Mcnair Building room B10.401.
How will such physical research data be secured?
     Data will be kept in locked file cabinets that only the research team has access to.
At what institution will the electronic research data be kept?
     
Data will be kept locked on network computers in our BCM offices, under the password protected server.
Address:\\discovery1.ad.bcm.edu\bcm-dept-icamp
Such electronic research data will be secured via BCM IT Services- provided secured network storage of electronic research
data (Non-Portable devices only):
     Yes
Such electronic research data will be secured via Other:
     No
Will there be anyone besides the PI, the study staff, the IRB and the sponsor, who will have access to identifiable research
data?
     
Yes, identify the classes of the persons:
Yes, identify the classes of the persons: People who ensure quality from the institutions where the research is being done,
federal and other regulatory agencies will have access to all of the research data.
Please describe the methods of transmission of any research data (including PHI, sensitive, and non-sensitive data) to
sponsors and/or collaborators.
     Transmissions, if any, will only happen via secure emails.
 
Will you obtain a Certificate of Confidentiality for this study?
     No
Please further discuss any potential confidentiality issues related to this study.
     NA
 
Section L:  Cost/Payment
Delineate clinical procedures from research procedures. Will subject's insurance (or subject) be responsible for research
related costs? If so state for which items subject's insurance (or subject) will be responsible (surgery, device, drugs, etc). If
appropriate, discuss the availability of financial counseling.
     
All clinical/standard procedures will be billed to the subject's insurance. These include, physician visits, debridement,
medications prescribed by physician.
There will be no research procedures charged to the subject or their insurance. This includes, the research device,
materials provided by the research team, visits with the research team.
If subjects will be paid (money, gift certificates, coupons, etc.) to participate in this research project, please note the total dollar
amount (or dollar value amount) and distribution plan (one payment, pro-rated payment, paid upon completion, etc) of the
payment.
Dollar Amount:
     135
Distribution Plan:
     
For taking part in this research, the subject may be paid a total of $135. Their compensation will be broken down as
follows:
Subjects will be paid $25 for 3 in person visits, $30 for every visit completed over the phone. There are a total of 5 visits.
Payments will be done using the ClinCard method. Their SSN will be requested for the research team to issue the
payments. The research study will also cover the subject's parking or transportation expenses to go to their research visits.
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Human Protocol Report
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Section M:  Genetics
How would you classify your genetic study?
     
Discuss the potential for psychological, social, and/or physical harm subsequent to participation in this research. Please
discuss, considering the following areas: risks to privacy, confidentiality, insurability, employability, immigration status,
paternity status, educational opportunities, or social stigma.
     
Will subjects be offered any type of genetic education or counseling, and if so, who will provide the education or counseling
and under what conditions will it be provided? If there is the possibility that a family's pedigree will be presented or published,
please describe how you will protect family member's confidentiality?
     
 
Section N:  Sample Collection
None
 
Section O:  Drug Studies
Does the research involve the use of ANY drug* or biologic? (*A drug is defined as any substance that is used to elicit a
pharmacologic or physiologic response whether it is for treatment or diagnostic purposes)
     No
Does the research involve the use of ANY gene transfer agent for human gene transfer research?
     No
O1.  Current Drugs
 
Is this study placebo-controlled?
     No
Will the research involve a radioactive drug?
     No
 
Section P:  Device Studies
     Does this research study involve the use of ANY device?
          Yes
Device 1:  Legsys
Device 2:   Kent Camera
Device 3:   Frailty Meter
Device 4:  Balansens
Device 5:   Pamsys
Device 6:  Orthofeet Shoes
 
Section Q:  Consent Form(s)
A PROSPECTIVE PROOF OF CONCEPT TRIAL TO EVALUATE EFFICACY, ACCEPTABILITY, AND PERCEPTION OF
BENEFIT OF AN INNOVATIVE PAIN RELIEF FOOTWEAR -ORTHOFEET
 
11/18/24, 6:34 PM
Human Protocol Report
https://brain.bcm.edu/esp1/reports/Human/Protocol.asp?protocol=451880
10/11

Section R:  Advertisements
Mode of Advertising:  Bulletin Board
Exact language of Advertisement:
     
Foot Pain Research Trial What have you tried to manage foot pain? Do you experience mild to severe foot pain? Would
you want to try on new shoes meant for relief for 6 weeks? If you answer yes to the following questions, you may qualify for
our clinical trial with OrthoFeet shoes! Benefits of participation include Help to advance scientific knowledge about foot
pain Use new shoes for foot pain relief! You will receive compensation for your time For more information, please contact
our research coordinators. Anmol Momin 713-798-8714 Anmol.momin@bcm.edu Nesreen El-Refaei 713-798-7470
Nesreen.el-refaei@bcm.edu
 
11/18/24, 6:34 PM
Human Protocol Report
https://brain.bcm.edu/esp1/reports/Human/Protocol.asp?protocol=451880
11/11