Micro-mobile Foot Compression Device to Improve Motor-function in People With Diabetes and Loss of Protective Sensation
Phase: PHASE2
Conditions: Diabetes, PAD, Lower Extremity Edema, Neuropathy;Peripheral, Foot Ulcer, Diabetic, Lymphatic Diseases
Sponsor: Baylor College of Medicine

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Institutional Review Board for Baylor College of Medicine and Affiliated
Hospitals
 
Protocol Number:    H-37962
Status:                        Approved
Initial Submit Date:  10/16/2015
Approval Period:       6/27/2018 - 6/26/2019
 
Section Aa:  Title & PI
A1. Main Title
AVEX FOOTBEAT--MICRO-MOBILE FOOT COMPRESSION DEVICE FOR REDUCING LOWER EXTREMITY EDEMA IN
PATIENTS WITH DIABETES: A PROOF OF CONCEPT STUDY
A2. Principal Investigator
Name:  
BIJAN NAJAFI
Phone:  
713-798-8070
Id:  
191680
Fax:  
Department:  SURGERY: VASCULAR SURGERY DIV.
Email:   
najafi@bcm.tmc.edu
Center:  
Mail Stn:  BCM390
A3.  Administrative Contact
Name:
TERRY FISHER
Phone:  
713-798-7916
Id:  
188284
Fax:  
Email:   
tfisher@bcm.tmc.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:  
JEFFREY ALAN ROSS
Phone:  
713-798-8944
Id:  
024225
Fax:  
713-790-9439
Department:  SURGERY: VASCULAR SURGERY DIV.
Email:   
jeffross@bcm.tmc.edu
Center:  
Mail Stn:  SM1025
Name:  
JOSEPH L. MILLS
Phone:  
713-798-8831
Id:  
188590
Fax:  
Department:  SURGERY: VASCULAR SURGERY DIV.
Email:   
jlmills@bcm.tmc.edu
Center:  
Mail Stn:  BCM390
Name:  
BRIAN D. LEPOW
Phone:  
713-798-2301
Id:  
197467
Fax:  
Department:  SURGERY: VASCULAR SURGERY DIV.
Email:   
lepow@bcm.tmc.edu
Center:  
Mail Stn:  BCM390
A5.  Funding Source:

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     Organization:  AVEX HEALTH
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
 
Section B:  Exempt Request
B.  Exempt From IRB Review
     Not Applicable
 
Section C:  Background Information
     
Diabetic foot ulceration (DFU) is a common and largely preventable complication. [1] While most of these ulcers can be
treated successfully, some will persist and become infected. Ultimately, nearly one fifth of patients with infected lower-
extremity diabetic ulcers will require amputation of the affected limb, resulting in staggering costs for both the patient and
the healthcare system. Prevention by identifying people at higher risk is the key for better clinical management of such
patients. It is not uncommon for patients suffering from diabetes to have concomitant lower extremity edema or even
venous insufficiency[2-4] and they subsequently may benefit from graduated compression[5-7]. However, because of the
common association of peripheral arterial disease (PAD) in patients with diabetes[8-10], most clinicians are reluctant to
apply compressive dressings in fear of exacerbating the symptoms of PAD and the possible resulting gangrene[11]. 
 
Unfortunately, this area has received comparatively little attention from industry, academia, or insurance providers. A novel
micro-mobile intermittent pneumatic foot compression device (AVEX Footbeat, Inc.) offers alternative means providing
lower extremity compression. This device is portable and can be used in ambulatory settings providing increased venous
blood and relief from concomitant lower extremity edema. 
 
 
 
Section D:  Purpose and Objectives
     The purpose of this study is to conduct an observational study with N=30 patients to assess whether this micro-mobile foot
compression device can help reduce lower extremity in patients with both diabetes and lower extremity edema without
compromising the vascular supply.
 
 
The main purpose of this study is to determine if the device lessens edema. This study will also evaluate a new research
device to see if it may help prevent diabetic foot ulcers. Additionally, it may potentially help delay progression of foot
disease and produce a better quality of life by providing a better blood flow to foot and ankle. 
 
 
Primary Endpoints: Reduction in lower extremity edema at 4 weeks of continuous device usage. Peripheral edema will be
measured at baseline, 48 hours, 1 week and 4 weeks. Peripheral edema will be directly measured by traditional volume
change assessment and indirectly by skin perfusion pressure assessment.
 
 
Secondary Endpoints: 1) Improvement in balance and fall risk as measured at baseline and 4 weeks. 2) 48 Hours of
continuous daily physical activity using a validated body worn sensor as measured at baseline and 4 weeks. 3) Gait
assessment at baseline and 4 weeks.
 

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Specific Aim and Hypothesis
 
 
Aim 1. To assess the effectiveness of a micro-mobile foot compression device that provides mild compression to help
reduce peripheral edema as compeered to baseline in patients with both diabetes and lower extremity edema in a four-
week observational clinical trial of 30 patients.
 
 
Hypothesis 1: The micro-mobile foot compression device will result in edema reduction when compared to baseline
peripheral edema for the study population.
 
 
Aim 2. To assess the effect of micro-mobile foot compression device on the macro and micro lower extremity circulation as
measured by Ankle Brachial Index (ABI) and Skin Perfusion Pressure (SPP) Measurements. 
 
Hypothesis 2: The micro-mobile foot compression device will help improve macro and micro- circulation in the lower
extremity of patients with diabetes and lower extremity edema as compared to baseline. We expect to see positive
changes in ABI and SPP measurements.
 
 
Aim 3. To assess the effect micro-mobile foot compression device on the quality of life quantified using the validated,
international qualify of life assessment survey SF12, fear of falling quantified by FES-I, and risk of falling assessment
quantified by gait, balance and spontaneous daily physical activity of patients with diabetes and lower extremity edema.
 
 
Hypothesis 3. The micro-mobile foot compression device will improve the quality of life, lower the risk of falling, lower fear
of falling, and improve activity level of patients as compared to baseline assessments.
 
Section E:  Protocol Risks/Subjects
E1.  Risk Category
     Category 2: Research involving greater than minimal risk, but presenting the prospect of direct benefit to the individual
subjects.
E2.  Subjects
Gender:
     Both
Age:
     Adult (18-64 yrs), Geriatric (65+ yrs)
Ethnicity:
     All Ethnicities
Primary Language:
     English, Spanish
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

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Section F:  Design/Procedure
F1.  Design
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.
     
In this proof of concept, intent to treat trial, 30 consecutive patients with diabetes and lower extremity edema will be
recruited from the outpatient clinic at Baylor College of Medicine. Patients will be consented per the local Institutional
Review Board’s guidelines and approval for this study.
Inclusion Criteria:
     
a) Males or females age 18-90 years old with history of type 1 or 2 diabetes and the ability and willingness to provide
Informed consent b) Patients at risk of developing diabetic foot ulcers c) Patient is willing to participate in all procedures
and follow up evaluations necessary to complete the study. d) Patients who have undergone lower extremity surgery /
amputation may be enrolled into the study at the clinical judgment of the Investigator
 
 
Exclusion Criteria:
     
a) Patients with severe peripheral vascular disease (ABI or ankle brachial systolic pressure index <0.5) b) Patients with
diabetic foot ulcers in the plantar foot region c) Patients with active wound infection, or untreated osteomyelitis d) Patients
currently on immunosuppressive drugs. e) Pregnant or breastfeeding females. (standard urine pregnancy done on women
during physical exam procedures) f) Acute fractures of the foot g) Acute heart failure h) Participation in an interventional
Study within the last 30 days i) Non-ambulatory or unable to stand without help or walk a distance of at least 6 feet without
assistance. k) Patients with major foot amputation. j) Patients who are unable or unwilling to participate in all procedures
and follow up evaluations h) Patients with major foot deformities which won’t fit in the diabetic shoes
 
 
F2.  Procedure
     Following is a summary of study procedures:
 
 
Study Day 0 (initiation), Visit 1 The following baseline values will be assessed and documented. 
 
 
Screening/ Baseline: Subjects will be screened to ensure that they meet the inclusion criteria of the study. The study will
be fully explained and written informed consent will be obtained from each patient prior to the initiation of screening
procedures. 
 
Cognitive assessment: The Montreal Cognitive Assessment (MOCA) is a series of questions used to assess cognitive
status. A score less than 26 could indicate cognitive impairment. Although it is not an exclusion criteria, a score less than
26 will require PCP permission. Written permission from the patient will be asked for in order to contact their PCP for
approval to participate in the study. 
 
 
Physical exam: Physical exam will be conducted, including vascular, dermatological, and neurological, as part of a regular
care visit. 
 
 
Medical History: A detailed medical history will include: previous medical history, location and duration of previous ulcers,
amputation (toe, foot, below knee, above knee), lower extremity bypass, lower extremity angioplasty, CABG, cardiac
angioplasty, last visit by physician (in weeks), and current/past use of special shoes or insoles. 
 
Neurological Evaluation: The Neurological assessment will consist of Vibratory Perception Threshold testing (VPT) using
the technique described by Young [12], and the 10 gram Semmes-Weinstein monofilament using the criteria described by
Armstrong and Lavery[13]. The presence of sensory neuropathy will be identified as vibratory perception threshold greater
than 25 volts or inability to accurately perceive a 10 gram Semmes-Weinstein monofilament at 1 or more of 10 test sites on
the sole and dorsum of the foot[14], which is a standard clinical measurement in diabetic patients.
 
 
Vascular Assessment: The vascular assessment will consist of palpation of the dorsalis pedis and posterior tibial arteries
and non-invasive Doppler studies. Ankle Brachial Index (ABI) will be determined for both extremities [14, 15]. ABI ratios
less than 0.5 will indicate severe vascular disease. These patients will be eliminated from the study per exclusion criteria. 
 
Additionally, skin perfusion pressure (SPP) monitor will be used to assess vascular status for all patients. SPP offers a
non-invasive and real-time assessment of critical limb ischemia. It indicates the pressure at which blood flow resumes in
capillaries. SPP is unaffected by falsely elevated systolic blood pressures, calcified arteries and peripheral edema.
Typically SPP readings are obtained by photoplethysmography (cuff occlusion and re-appearance of pulsatile blood flux)
or laser Doppler (cuff occlusion/thermal hyperemia and movement of red blood cells). 
 

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Edema Assessment – Peripheral edema will be assessed at baseline, using clinical signs and circumference
measurements at foot, calf and ankles or via volumetric water displacement. 
 
 
Physical Performance Tests - Balance assessment: Balance will be quantified using validated body worn sensors
(BalanSens™, Biosensics LLC, USA). The system measures ankle and hip motion in three dimensions (3D), 2D COM
sway as well as RCI in ML and AP directions [16]. Balance will be assessed according to Romberg protocol during eyes-
open and eyes-closed condition during double, semi-tandem, and full tandem stances (see the attached list of
questionnaires/assessments for further explanation).
 
 
Physical Performance Tests - Gait assessment: Gait performance will be assessed using by a validated body worn
sensors (LegSys™, Biosensics LLC, USA) [17-19]. The device uses five sensor modules respectively attached to right and
left anterior shins, right and left anterior thighs, and posteriorly to the lower back. Based on the subject’s height and using
a two-link inverse pendulum model the following spatio-temporal gait parameters will be estimated: velocity, stride length,
stride time, double support, single support, stride-to-stride variability, and gait initiation [20]. In addition, the COM range of
motion during walking will be calculated by using the data from the sensor attached to lower-back. Gait will be assessed
over a distance of 20 meters under 4 conditions: (1) walking at habitual speed (single task); (2) walking at habitual speed
while counting backward from a random number (e.g. 83) (dual task); (3) walking at maximum speed (fast walking), (4)
Timed Up and Go (TUG); and (5) alternative 8 step test
 
 
Upper Extremity Test: Investigators will measure arm motion from each participant by implementing a validated technology
based on wearable sensor system named LegSys. This system will assess respectively spatio-temporal parameters of arm
motion in a clinical setting. The LegSys system will be used with 2 sensors to capture arm motion, one placed at the
subject's wrist and another at their elbow. While being at a comfortable position, the subject will be asked to flex and
extend their arm for 20 seconds at a fast speed. Subject will also be asked to repeat this task but counting backwards as
they flex and extend their arm (dual task). We may also add wrist weights (no more than 5 pounds) to increase the
resistance of this task. 
 
 
Objective assessment of physical activity: Spontaneous daily physical activities as well as the risk of falling during activity
of daily living are quantified using a validated body worn sensor named PAMSys™ (Biosensics, LLC, USA). PAMSys is a
small long-term recording movement sensor which is unobtrusively inserted into a comfortable shirt (PAMshirt™). The
system contains inertial sensors with software developed to identify postural positions and movements such as walking,
standing, sitting, or lying during a measuring period of 48 hr. It has proven to be sensitive (87–99%) and specific (87–
99.7%)[21, 22] for postural position and detection of walking in different samples of older adults and patient groups. 
 
 
Plantar Pressure Assessment: Plantar pressure will be examined using computerized pressure insoles® (Fscan®,
TekScan, Boston, MA). Subjects will be asked to walk a distance of approximately 20 feet at habitual speed while wearing
regular shoes with and without AVEX insoles. 
 
 
Assessment of user friendliness, acceptability, and perception of need: We will use a questionnaire tailored to the topic of
this study to evaluate the perception of the target population in receiving benefit from the proposed technology. Subjects
are asked to answer the questionnaire at the end of study. The questionnaire includes 11 items and allows assessing how
target population perceives the need of such technology in management of their problem. 
 
 
Other assessments: Other relevant assessments are Demographic/Health questionnaire, the Mini-Metal State Exam, the
mobility-tiredness scale, Barthel Index, Depression Scale, fear of falling (Short-Falls Efficacy Scale – International)[25],
quality of life (SF-12 Health Survey)[26], Fried Frailty Criteria, Foot Questionnaire, Pain Assessment, Fall Log and Contact
Agreement, Physical activity log, follow-up questionnaire, and Shoe-fit test 
 
 
AVEX insole: The AVEX insole will be given to the subject. The research personnel will adjust the clutching reel (BOA
technology) in order to ensure a comfortable shoe fit. The research personnel will also provide device education to the
subject and will answer any questions which may arise. 
 
 
Study Day 1, Visit 2 48-hour follow up: All participants will be asked to return to clinic approximately 48 hours after visit 1.
In this visit, (1) any adverse events will be assessed; (2) activity measurement (body sensor) will be returned; (3) AVEX
insole data will be downloaded to ensure operability and patient compliance; and (4) further device education will be
provided in case any issues have risen
 
 
Study Day 2, Visit 3 1-week follow-up: All participants will be asked to return to clinic approximately 1 week after visit 1. In
this visit, (1) any adverse events will be assessed; and (2) AVEX data download to ensure operability and patient
compliance. Device education will be provided if needed. The subject will be asked to return the device at their next visit.
Similar assessments performed during visit 1 may be performed again during this visit.
 
 
Study Day 3, Visit 4 4-week follow-up: All participants will be asked to return to clinic approximately 4 weeks after visit 1. In
this visit, outcome assessment using similar assessments described for Study Day 0 will be performed. In addition, benefit
and user-friendliness of the AVEX insoles and Boa Technology ‘Clutch Reel’ will be assessed using a questionnaire. The
subject will return the device back to the research personnel. 
 
 
Patients will be asked to wear a comfortable shirt which holds a small activity monitor (PAMSys) for a period of 48 Hours (2
days). Patients will be requested to return this device via a pre-paid FEDEX envelope
 
 

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Study Day 4, Visit 5 Three month follow-up: All participants will be contacted by the study coordinator approximately three
months post the last study visit (Visit 4) to document potential incident of diabetic foot ulcer or falls.
 
 
The researchers will take digital photographs of you and videotape you and your feet during the study to monitor progress
or deterioration (worsening) due to intervention. This is done using a normal digital camera for visual images and a thermal
(heal sensitive) camera for thermal images. Both these methods are non-invasive. **We will NOT blur your face out in the
photographs/videos. While we do all our efforts to mask your face in some cases (for example. journal policy) this may not
be practical. We will only use videos and photos of you for scientific presentations or scientific publications. Initial your
decision below.
 
 
____I agree to have my photographs/videotape presented in scientific presentation or scientific publication
 
 
____I do NOT agree to have my photographs/videotape presented in scientific presentation or scientific publication
 
 
Please provide below your Emergency contact information:
 
 
Contact name: ___________________ 
 
 
Relationship: _____________________
 
 
Phone number: ____________________
 
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 an initial proof of concept pilot study. The results of this study will allow for the calculation of an appropriate sample
size for a larger proof of superiority (over current standard of care) trial.
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?
     
Statistical Analysis - This study includes three hypotheses. To examine whether the proposed micro-mobile foot
compression device will result in a edema reduction compared to the baseline (H1), we will use ANOVA and Fisher’s exact
tests for intra-subject rate of edema reduction using the outcome explained before. Multivariate and multiple linear
regression test will be used for testing the effects of confounding factors including age, gender, BMI, foot insensitivity, etc.
Additional, paired t-test will be used to examine whether amount of edema reduction at the end of study is significant
compared to baseline. We will use Pearson correlation of coefficient and Fisher’s exact tests to examine whether severity
of neuropathy has any significant association with the rate of edema reduction. Finally, we will use multiple linear
regression model to examine whether subject’s level of activity, BMI, ABI, Skin perfusion pressure, and micro-mobile foot
compression device are independent predictors for the rate of edema reduction. 
 
 
To examine whether the proposed sock will help improve macro and micro-circulation in the lower extremity of patients
(H2), we will use the similar analytical plan explained above by considering change in Skin perfusion pressure and ABI as
dependent variables. For identifying the predictors, we will use multiple linear regression model and Anova (n-way). The
independent variables will be severity of neuropathy quantified using Semmes Weinstein Monofilament, the level of
activity, BMI, and age.
 
 
To examine whether the proposed socks will improve the activity level and quality of life (H3), we will use ANOVA
multivariate test. The dependent variables will be number of total steps per day, duration of walking and standing, duration
of longest episode of walking (i.e. continuous walking without stop), number of walking episode, duration of sit-to-stand
and stand-to-sit postural transition, and SF12. We will use multiple linear regression model and multi-variant test to
examine the effect of confounding parameters such as weather condition, BMI, age, etc.
 
 
 
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:

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     The AVEX Footbeat insole is an investigational device, which has been designed to enhance blood flow to lower
extremities via a Micro-Mobile Foot Compression Device. The compression component applied pressure under your foot
arch. We will perform initial screening to ensure the safety of the device. But as any new insole, there is some risk that the
insole caused some discomfort or cause development of foot ulcers. It is important to notify us if you feel discomfort on
wearing the insoles or if you feel excessive pressure to your feet because of wearing the AVEX Footbeat insole. 
 
 
The study device and technology is completely non-invasive, safe, non-toxic and non-ionizing. The potential risks to you
are minimal. 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 cell-phone battery), in order to
avoid any risk of shock the monitor should not be submerged or saturated with fluids during operations or cleaning. 
 
 
You must be willing to charge device battery daily. Otherwise they will not receive benefit from compression component
during treatment.
 
 
The assessments described above are expected to be minimal risk and probability and magnitude of harm or discomfort
anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the
performance of routine physical or psychological examinations or tests.
 
 
Please note that there is also the possibility for loss of confidentiality. The PI and the research team will minimize the
possibility of for loss of confidentiality by keeping all the physical data locked in cabinets only accessible to the research
team. The electronic data will be kept on network password protected institutional computers. And, subject PHI will be
coded as much as possible to minimize the potential for loss of confidentiality.
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.
     There may be no direct benefit to you by being in this study. However, the device may improve blood flow and reduce the
number of traumatic amputations.
Describe potential benefit(s) to society of the planned work.
     
What the researchers find out from this study may help other people with diabetes and history of foot ulcers. This research
utilizes a new device to improve blood flow, which may help to prevent diabetic foot ulcer and enhance balance; it is part of
a larger prevention initiative to reduce the high number of traumatic amputations associated with the diabetic foot disease.
Do anticipated benefits outweigh potential risks? Discuss the risk-to-benefit ratio.
     
The risks involved with this study are very minimal. There is a possibility for a loss of confidentiality and some risks still
remain unknown. There is also the possibility of minimal risks associated with use of the devices in this study. However,
there is a chance that the device may provide some benefits. Therefore, the anticipated benefits outweigh the potential
risks.
 
Section J:  Consent Procedures
J1.  Waiver of Consent
Will any portion of this research require a waiver of consent and authorization?
     Yes
Please describe the portion of the research for which a waiver is required. (Example: chart review to determine subject
eligibility)
     We will review our patient charts to determine and verify patient eligibility.
Explain why the research and the use or disclosure of protected health information involves no more than minimal risk
(including privacy risks) to the individuals.
     A plan exists such that only the PI and clinical database administrator have access to these password-protected identifiers,

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which are subsequently removed when sharing data with co-investigators, analyzing data, and reporting or disseminating
aggregate outcome data (often reported as rates) in scholarly publications and scientific presentations. The use or
disclosure of PHI involves no more than minimal risk to the individuals and the waiver will not adversely affect the privacy
rights and the welfare of the individuals.
 
 
The PHI will not be reused or disclosed to (shared with) any other person or entity, except as required by law, for
authorized oversight of the research study, or for other research for which the use or disclosure of the PHI would be
permitted under the Privacy Rule.
 
 
Explain why the waiver will not adversely affect the privacy rights and the welfare of the research subjects.
     
Patients will receive the same standard of care regardless to whether they participate or not. These patients will be clinic
or established patients of the PI. Therefore, they already consent to a review of their charts at the time they are seen in
clinic the first time and before they are even added to the PI's patient database.
Explain why the research could not practicably be conducted without the waiver and could not practicably be conducted
without access to and use of the protected health information.
     If we are not allowed to search our patient’s records, we cannot identify and recruit the patients that are eligible for the
study. This research will not affect the subject’s care as they are receiving the standard of care.
Describe how an adequate plan exists in order to protect identifiers from improper use and disclosure.
     
The use or disclosure of PHI involves no more than minimal risk to the individuals and the waiver will not adversely affect
the privacy rights and the welfare of the individuals as subjects will receive the same standard of care regardless of
whether or not they participate in the study.
Describe how an adequate plan exists in order to destroy identifiers at the earliest opportunity consistent with conduct of the
research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by
law.
     
We will destroy identifiers at the earliest opportunity consistent with conduct of the research absent a health or research
justification for retaining them or a legal requirement to do so. The use or disclosure of PHI involves no more than minimal
risk to the individuals and the waiver will not adversely affect the privacy rights and the welfare of the individuals. PHI is not
disclosed to any other person or entity except for the authorized oversight of the research study by the PI and the clinical
database administrator. The Division uniformly adheres to all patient and patient data security and confidentiality rules and
regulations set forth by the College.
Describe how adequate written assurances exist in order to ensure that the PHI will not be reused or disclosed to (shared
with) any other person or entity, except as required by law, for authorized oversight of the research study, or for other research
for which the use or disclosure of the PHI would be permitted under the Privacy Rule.
     
The PHI will not be reused or disclosed to (shared with) any other person or entity, except as required by law, for
authorized oversight of the research study, or for other research for which the use or disclosure of the PHI would be
permitted under the Privacy Rule.
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 #:
     No
Partial Social Security # (Last four digits):
     No
Billing or financial records:

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     No
Photographs, videotapes, and/or audiotapes of you:
     Yes
Other:
     No
Will additional pertinent information be provided to subjects after participation?
     No
If No, explain why providing subjects additional pertinent information after participation is not appropriate.
     Subjects will be provided the same standard of care whether or not they participate in the study. Therefore, providing
additional information is irrelevant.
 
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.
     
Subjects will be recruited from the PI's own practice. He may get some referrals from his colleagues that work in the same
clinic. We have included a Waiver of Partial Consent to cover our screening process. The PI will identify eligible subjects
and alert the coordinator. The coordinator will review all the details of the study with the subject and/or their family. If the
subject agrees to participate in the study, they will be screened and then enrolled into the study. 
 
Thomas A. Glazier Senior Education Center and the Jim and JoAnn Fonteno Senior Education Center will allow the
research team to display information regarding the research study as well as provide the research team with a space to
conduct consenting and assessments. 
 
Please note that all subjects will be consented before any screening procedures are done. 
 
Spanish speakers will be consented using a full Spanish version of the consent. We have Spanish speaking coordinators
on staff that can translate the consent for the patients. The coordinator who translates the consent will sign off on the
Translator signature line of the ICF.
Are foreign language consent forms required for this protocol?
     Yes
Which of the following ways will you document informed consent in languages other than English?
     A full-length informed consent document
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?

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     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 #:
     No
Partial Social Security # (Last four digits):
     No
Billing or financial records:
     No
Photographs, videotapes, and/or audiotapes of you:
     Yes
Other:
     No
At what institution will the physical research data be kept?
     All data will be kept at in our offices at our BCM McNair office building
How will such physical research data be secured?
     All physical data will be kept in file cabinets that have a lock and key.
At what institution will the electronic research data be kept?
     Electronic data will be kept on Network Severs that are password protected. The computers are in the McNair building.
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?
     No
Please describe the methods of transmission of any research data (including PHI, sensitive, and non-sensitive data) to

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sponsors and/or collaborators.
     Transmissions will only be sent via secure and encrypted email.
 
Will you obtain a Certificate of Confidentiality for this study?
     No
Please further discuss any potential confidentiality issues related to this study.
     Please note that there is an adequate plan in place to destroy identifiers at the earliest opportunity consistent with conduct
of the research absent a health or research justification for retaining them or a legal requirement to do so.
 
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.
     Participating in this study will take time and will not involve any direct cost to the subject. Subject medical insurance will not
be billed for this purpose. All study procedures are research related and will be covered by the sponsor.
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:
     120
Distribution Plan:
     By law, payments to subjects may be considered taxable income. You will receive $30 for each completed study visit,
including a maximum of $120. If you do not complete the study, you will still be paid for the visits you have completed.
 
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
SAMPLE:  Urine
What is the purpose of the sample collection?
     Pregnancy test for women
For blood draws, specify the amount drawn, in teaspoons, at each visit and across the course of the subjects entire
participation time.
     We will be using a standard urine test. We will collect only what is required to perform the test.
Is there the possibility that cell lines will be developed with this sample?No
Sample will be obtained from:
     Research Labs
Will the sample be stripped of identifiers?
     No
If sample will be released outside the hospital:

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Will sample be released to anyone not listed as an investigator on the protocol? Will the information be identifiable, coded or
de-identified?
     Sample will be coded along with all other study data collected.
Will sample material be sold or transferred to any third parties? Will the information be de-identified?
     Sample not sold.
If sample will be banked for future use:
Where will the sample be banked and for how long?
     Sample not banked.
Does the banking institution have an approved policy for the distribution of samples?
     NA
If the entire sample will NOT be used during the course of this research study:
Will the remaining tissue be discarded? If not what will be done with the remaining sample after study completion and how
long will the sample be kept?
     NA
Will samples be made available to the research subject (or his/her medical doctor) for other testing?
     No
If a subject withdraws from the study:
Will subject have the option to get the remaining portion of their sample back?
     No
Will samples be destroyed? If not, will they be kept anonymously? What will happen to the sample if the subject revokes
authorization?
     Sample will be destroyed if subject withdraws consent.
Will data obtained from their sample be deleted? What will happen to the sample if the subject revokes authorization?
     All data will be deleted and sample will be discarded if subject revokes authorization.
Will study data or test results be recorded in the subject's medical records?
     Yes
Will results of specific tests and/or results of the overall study be revealed to the research subject and or his/her doctor?
     Yes.
Please identify all third parties, including the subject's physician, to receive the test results.
     The pregnancy tests information will be recorded in the patient's medical record and accessible by the research team and
subject's doctor.
 
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 that is not approved by the FDA?
     No
 
Section P:  Device Studies
     Does this research study involve the use of ANY device?

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          Yes
Device 1:  AVEX Health & Boa Technology `Clutch Reel'
Device 2:  LegSys for Gait assessment
Device 3:  BalanSens for Balance assessment
Device 4:  Tekscan
Device 5:  PAMsys
 
Section Q:  Consent Form(s)
AVEX
 
Section R:  Advertisements
Mode of Advertising:  Other: Bullentin Board, Local Houston Churchs' Website, social media
Exact language of Advertisement:
     Novel Shoes & Insoles for Adults with Diabetes and at Risk for Foot Problems 
 
 
To enroll in this study, Contact Ana or Ivan (713) 798– 7537 or (713) 798– 7538
 
 
interdisciplinary Consortium on Advanced Motion Performance
 
 
Are you having pain in your feet due to diabetes? If yes, you may qualify for a unique study that could reduce: - pain in
your feet, - numbness & tingling - swelling as well as possibly enhance your balance and walking performance. 
 
Contact Baylor College of Medicine iCAMP at (713) 798-7537 or (713) 798– 7538 for more information.
 
 
Who we are
 
 
Bijan Najafi, PhD Principal Investigator Professor of Surgery Director, iCAMP Bijan.Najafi@bcm.edu
 
 
Ana Enriquez, BS Lab Manager iCAMP ana.enriquez@bcm.edu 
 
 
Ivan Marin, BS Research Coordinator iCAMP Ivan.Marin@bcm.edu
 
 
Are you? Are you an adult who has diabetes ? If so... Are you interested in volunteering for “high-tech” studies targeted to
reduce swelling in ankles, pain and numbness in feet and improve balance?
 
 
THEN… You are eligible to participate in a novel study that uses state-of-the-art technology to assess benefit of a novel
footwear to improve the blood flow in your feet. 
 
 
Objectives BCM iCAMP at the Department of surgery has been partnered with AVEX LLC to test an innovative insole
device for improving blood flow, improving balance and reducing your feet problems. If proven effective, the technology
could help enhance balance, reduce swelling and promote a strong and healthy life.
 
 
What exactly do I do? We will provide you with a new pair of shoes and insoles. We will study your walking and balance
patterns and measure your numbness throughout a month long period. During this period you will ONLY be seen 4 times.
Qualifying participants will be eligible to receive an innovative footwear to reduce numbness at NO cost. 
 
 
Why participate? It could help you increase your circulation in your feet and ankles When there is numbness in the feet, a
little cut could potentially become a troubling ulcer and you are at higher risk of falling It could help with reduction of
swelling and pain. Need some extra cash? We compensate with $30 per visit. You will be helping scientist know more
about these technologies which could help others with these problems! 
 
Equipment
 
 
Special insoles with a pump that delivers a massage to the arch of your foot.
 
 
Innovative a wearable system using sensors attached to shins, thighs, and lower back to help assess your quality of
walking and balance 

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Enroll now! In order to enroll, see the front side of this pamphlet for contact information
 
 
 
 
Mode of Advertising:  Other: Bulletin Board, BCM Website, BCM Clinic waiting areas, distributed in the
community, social media
Exact language of Advertisement:
     
Do you you have diabetes and concerns about falling?
 
 
Interested to try a revolutionary footwear that massages your feet at no cost to you? Be compensated up to $120!
 
 
*Are you an adult (50 years or older) who has diabetes? *Do you have pain in your feet? *Do you have numbness and
tingling in your feet? *Do you have swelling?
 
 
If so, you may qualify for our study!
 
 
Benefits of participation include *Potential improvement of pain, swelling and numbness in your feet. *Potential
improvement of balance and better walking performance *Advancement of scientific knowledge to help other
 
 
For more information please contact the research coordinator list in the following
 
 
Ivan Marin Research Coordinator 713-798-7538 ivan.marin@bcm.edu
 
 
Louie Morsy Research Coordinator 713-798-8714 louie.morsy@bcm.edu
 
 
AVEX Balance Study 713-798-7538
 
 
Michael E. DeBakey Department of Surgery 7200 Cambridge St. B01.529 Houston Texas Phone 713-798-7537; Fax 713-
798-8460 www.bcm.edu/icamp
 
 
Mode of Advertising:  Other: BCM Website, Social media, Community outreach
Exact language of Advertisement:
     Video in section S shows testimony of participant regarding study device.