A Prospective Randomized-controlled Trial of Custom-manufactured vs. Off-the-rack (OTR) Compression Hosiery for Initial Management of Venous Disease
Phase: NA
Conditions: Venous Disease
Sponsor: The University of Texas Health Science Center, Houston

IRB APPROVAL DATE: 03/02/2017 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
A prospective randomized-controlled trial of custom-manufactured vs. off-the-rack (OTR)  
compression  hosiery  for  initial  management  of  venous  disease 
 
NCT03630185 
 
Version Date: 03/02/2017 
 
 

IRB APPROVAL DATE: 03/02/2017 
 
Custom vs OTR compression hosiery for venous disease 
 
Study Protocol 
 
 
Table of Contents 
I. 
LIST OF ABBREVIATIONS .............................................................................................................. 3 
II. 
PRINCIPAL INVESTIGATOR & RESEARCH TEAM ........................................................... 3 
III. 
STUDY SITE ............................................................................................................................................ 3 
IV. 
CONTACT INFORMATION .............................................................................................................. 4 
V. 
RESEARCH SYNOPSIS .................................................................................................................... 4 
A. 
Study Title ................................................................................................................................................................... 4 
B. 
Clinical Phase ............................................................................................................................................................ 4 
C. 
Study Population ...................................................................................................................................................... 4 
D. 
Study Design ............................................................................................................................................................. 5 
E. 
Sample Size ............................................................................................................................................................... 5 
F. 
Study Duration .......................................................................................................................................................... 5 
G. 
Study drug and Intervention Description...................................................................................................... 5 
H. 
Primary Objective .................................................................................................................................................... 5 
I. 
Secondary Objectives ........................................................................................................................................... 5 
VI. 
BACKGROUND AND SIGNIFICANCE ....................................................................................... 6 
VII. 
PRIMARY OBJECTIVES ................................................................................................................... 6 
H. 
SECONDARY OBJECTIVES ........................................................................................................... 7 
IX. 
STUDY POPULATION ........................................................................................................................ 9 
X. 
STUDY DRUGS .................................................................................................................................. 10 
XI. 
STUDY SCHEDULE ......................................................................................................................... 10 
XII. 
STUDY DESIGN/METHODOLOGY .......................................................................................... 10 
Study Conduct .................................................................................................................................................................. 12 
1. 
Screening ................................................................................................................................................................. 12 
2. 
Quality of life assessment - Brief Pain Inventory .................................................................................. 12 
3. 
Enrollment ................................................................................................................................................................ 13 
4. 
Randomization and Allocation Concealment .......................................................................................... 13 
5. 
Preoperative assessment ................................................................................................................................. 14 
6. 
Follow-up .................................................................................................................................................................. 14 
1 | P a  g e 
IRB NUMBER: HSC-MS-17-0015 

Stocking Protocol 
IRB NUMBER: HSC-M2S-17-0015 
IRB APPROVAL DATE: 03/02/2017 
 
 
7. 
Termination of enrollment................................................................................................................................. 15 
8. 
Termination of Study ........................................................................................................................................... 15 
XIII. 
ADVERSE EVENT REPORTING ............................................................................................... 15 
XIV. 
STATISTICAL ANALYSIS PLAN ................................................................................................ 16 
A. 
Primary Outcomes ............................................................................................................................................... 17 
A. 
Secondary Outcomes ......................................................................................................................................... 17 
B. 
Sample Size Determination ............................................................................................................................. 17 
XV. 
ETHICS ................................................................................................................................................... 18 
B. 
Privacy and Confidentiality .............................................................................................................................. 19 
C. 
Risk/Benefit ............................................................................................................................................................. 20 
XVI. 
STUDY TIMELINE ............................................................................................................................. 20 
XVII. DATA SAFETY MONITORING .................................................................................................... 21 
XVIII. CONFLICT OF INTEREST ............................................................................................................ 21 
XIX. 
FUTURE PUBLICATION AND PRESENTATION ............................................................... 21 
XX. 
References ............................................................................................................................................ 22 

Stocking Protocol 
IRB NUMBER: HSC-M3S-17-0015 
IRB APPROVAL DATE: 03/02/2017 
 
 
I. 
LIST OF ABBREVIATIONS 
 
 
AE 
Adverse Effects 
 
CEAP Clinical, Etiology, Anatomy, Physiology disease severity classification 
FDA 
Food and Drug Administration 
PI 
Principal Investigator 
 
 
 
II. 
PRINCIPAL INVESTIGATOR & RESEARCH TEAM 
 
 
Principal investigator: Stuart A. Harlin, MD (Vascular Surgeon) 
 
 
Co-Investigators: 
Charles C. Miller, PhD (Biostatistician) 
 
Research Team: 
Susan Pouliot, RN (Research Nurse) 
 
III. 
STUDY SITES 
 
1. UT  Physicians Cardiothoracic and Vascular Surgery at Katy 
 
Katy, Texas 
 
2. Bayshore UTP Clinic 
 
Houston, Texas 
 
3. UT Physicians EP Heart- Sugarland 
Sugarland, Texas 
4. Department of Cardiothoracic and Vascular Surgery 
University of Texas Medical School at Houston 

Stocking Protocol 
IRB NUMBER: HSC-M4S-17-0015 
IRB APPROVAL DATE: 03/02/2017 
 
 
 
IV. 
CONTACT INFORMATION 
 
1. Stuart A. Harlin, MD 
 
Principal Investigator 
 
6400 Fannin Street, Suite 2850, Houston, TX, 77030 
 
Phone (713) 486 – VEIN (8346) 
 
Stuart.A.Harlin@uth.tmc.edu 
 
2. Susan Pouliot, RN 
 
Research Nurse 
 
6400 Fannin Street, Suite 2850, Houston, TX, 77030 
 
Phone (713) 486 – 5131 
Fax (713) 512 – 7200 
 
Susan.M.Pouliot@uth.tmc.edu 
 
V. 
RESEARCH SYNOPSIS 
 
 
A. Study Title 
 
Study Full Title 
 
A prospective randomized-controlled trial of custom-manufactured vs. off-the-rack 
(OTR)  compression  hosiery  for  initial  management  of  venous  disease  
Study Short Title 
Custom vs OTR compression hosiery for venous disease 
 
B. Clinical Phase 
 
Phase IV 
 
C. Study Population 

Stocking Protocol 
IRB NUMBER: HSC-M5S-17-0015 
IRB APPROVAL DATE: 03/02/2017 
 
 
 
The study will include patients aged 18 and over who have CEAP classification 2-5 
venous disease and require compression as definitive therapy or in preparation for 
ablation therapy. 
D. Study Design 
 
Prospective double-blinded, controlled randomized clinical trial with 2-armed parallel- 
group sequential design 
E. Sample Size 
 
200 
 
F. Study Duration 
 
2 years 
 
G. Study device and Intervention Description 
 
Subjects will be randomized into two groups: group A will receive custom- 
manufactured compression hosiery (Isobar compression garment), and group B will 
receive off-the-rack stockings (Sigvaris). 
H. Primary Objective 
 
To assess the efficacy of custom-manufactured compression hosiery compared to off- 
the-rack compression hosiery for improving patient satisfaction, health-related 
quality of life and compliance with prescribed compression therapy 
I. Secondary Objectives 
 
 To identify subgroups that may benefit more from custom hosiery. 
 
 To determine whether improved fit affects likelihood to progress to invasive 
treatment. 

Stocking Protocol 
IRB NUMBER: HSC-M6S-17-0015 
IRB APPROVAL DATE: 03/02/2017 
 
 
 
VI. 
BACKGROUND AND SIGNIFICANCE 
 
 
Currently available off-the-rack compression hosiery are manufactured in eight 
fixed sizes (S-XLFC) that cannot be varied in size over their length to accommodate 
unusual anatomic patterns (eg., small ankle with large calf or vice versa) and may not 
achieve a comfortable fit that meets the compression goal over a uniform distribution of 
the limb. The custom-fitted garment is manufactured specifically for each patient based 
on measurements taken with a 3-dimensional volumetric laser scan of the extremity, 
and can be sized individually to each limb. In addition to providing data to computer 
assisted design-enabled manufacturing equipment, the scan data can be downloaded 
for analysis and may be useful for identifying patients for whom custom stockings are 
most beneficial and may ultimately be useful for prediction compliance and patient 
satisfaction. We propose to scan all trial participants prior to randomization so we can 
assess this in a control group as well. 
 
 
VII. 
PRIMARY OBJECTIVES 
 
To assess the efficacy of custom-manufactured compression hosiery compared 
to off-the-rack compression hosiery for improving patient satisfaction and compliance 
with prescribed compression therapy. 
1) Health-Related Quality of Life (HRQoL): We will use the short-form 12-item 
 
(SF12) HRQoL instrument for measuring HRQoL. It has been used widely and 
validated in many health conditions, and can be administered to patients in less 
than 5 minutes. It produces overall HRQoL estimates and subscale scores that 
assess both mental / emotional and physical functioning related to health. 

Stocking Protocol 
IRB NUMBER: HSC-M7S-17-0015 
IRB APPROVAL DATE: 03/02/2017 
 
 
 
2) Five-point satisfaction scale: This scale is used to assess the patient’s pain 
 
management experience during their postoperative care. It consists of patients 
rating their overall postoperative pain management experience using a 5-point 
rating system. The scale ranges from 1 to 5, with 1 being “extremely dissatisfied”, 
2 “somewhat dissatisfied”, 3 “Neutral/Neither satisfied nor dissatisfied”, 4 
“somewhat satisfied” and 5 “extremely satisfied” with their postoperative pain 
care. This rating has been used in other clinical trials and has been shown to be 
a reproducible assessment tool. 
3) Brief Pain Inventory: The Brief Pain Inventory is a medical questionnaire used to 
 
measure pain, developed by the Pain Research Group of the WHO Collaborating 
Centre for Symptom Evaluation in Cancer Care.1,2 
Primary outcome measures 
 
HRQoL, BPI and 5-point satisfaction scale will be assessed at baseline, at 
clinical follow-up at 90 days. Additionally, the BPI will also be administered via phone at 
6 weeks. 
Compliance with stocking use will be measured by a daily diary entry and will be the 
accumulated total of hours worn over 90 days. 
 
 
H. SECONDARY OBJECTIVES 
 
 To identify subgroups that may benefit more from custom hosiery. 
 
 To determine whether improved fit affects likelihood to progress to invasive 
treatment. 
 
Secondary outcome measures 

Stocking Protocol 
IRB NUMBER: HSC-M8S-17-0015 
IRB APPROVAL DATE: 03/02/2017 
 
 
 
 The sample size (200 subjects) will allow us to investigate subgroup effects. 
 
Preliminary a priori hypotheses are that patients with difficult to fit legs (eg., large 
calf/ankle ratio) with have significant improvements in compliance and 
satisfaction with custom fit hosiery. 
 Progression to ablation therapy will be determined by patient preference for 
further intervention. We will measure efficacy as a simple proportion between 
the randomized groups. 

Stocking Protocol 
IRB APPROVAL DATE: 03/02/2017 
 
 
 
IX. 
STUDY POPULATION 
 
 
The target population of our study will be comprised of patients that are 18 years-old 
and above that present to our group at The University of Texas Medical School at 
Houston with venous disease requiring treatment with compression. 
Inclusion/Exclusion Criteria 
 
 
Patients will be eligible for the study if: 
 
 18 years-old or older, and 
 
 Ability to comprehend and sign an informed consent and complete study 
questionnaires 
 Patient is participating in usual work and home activities with no changes anticipated 
for the duration of the study 
 The use of compression stocking is prescribed in accordance with the usual practice 
and management of  venous disorders 
 The patient will confirm they are willing to pay for the compression stockings. 
Patients will be excluded from the study if: 
 
 The patient has a known allergy to any component of the stocking (latex, etc) 
 
 The patient has non-venous source of pain in either leg that could, in the opinion of 
the investigator, confound the results of the study i.e.Neuropathy, Arterial 
insufficiency, Diabetes 
 The patient is confined to bed 
 The patient has uncontrolled Congestive Heart Failure 
 The patient has acute dermatitis 
 The patient has weeping dermatosis 
 Patients with venous ulcers will be excluded. 
 
Protocol Deviation: 
 
 Patient is randomized but does not receive the correct treatment assignment 
 
 
 
IRB NUMBER: HSC-M9S-17-0015 

Stocking Protocol 
IRB NUMBER: HSC-1M0S-17-0015 
IRB APPROVAL DATE: 03/02/2017 
 
 
 
Withdrawal criteria: 
 
 Voluntary: patients who had consented and enrolled in the trial will maintain their 
right to withdraw at any point during the study as explained in the informed consent. 
 
 In case of unexpected/unpredicted events, the Principal Investigator and research 
staff may determine that patient meets criteria for withdrawal. 
 
X. 
STUDY DEVICES 
 
 
The Custom stocking, (Isobar Compression Garment) is an FDA Class 1 device. 
The control stocking (Sigvaris) is also an FDA Class 1 device. These devices are rated 
at 15 mmHg compression and are comparably priced. 
 
XI. 
STUDY SCHEDULE 
 
 
Expected start date after IRB Approval: Eligible to begin January 2017 
Expected end date for enrollment: January 2019 
Length of treatment-phase enrollment for each patient: 90 days 
 
Length of follow-up for each patient: 90 days from initiation of compression for primary 
endpoint; six months for assessment of likelihood to receive follow-on ablation therapy. 
 
 
 
XII. 
STUDY DESIGN/METHODOLOGY 
 
 
This will be a single institution, prospective, blinded, randomized, controlled 

Stocking Protocol 
IRB NUMBER: HSC-1M1S-17-0015 
IRB APPROVAL DATE: 03/02/2017 
 
 
 
clinical trial with a 2-arm parallel-group design to assess the efficacy of custom-fitted 
compression hosiery vs off-the-rack compression hosiery. 
 
The custom stockings take 2 weeks to manufacture. In order to maintain the 
blind, stockings will be procured by the UT CV Surgery purchasing personnel and 
distributed to the subjects in unmarked packaging within three weeks of randomization. 
Neither the prescribing physician nor the patient will know the treatment assignment. 
 
Screened patients meeting the eligibility criteria will have a below-knee laser 
measurement scan, and will be randomized into one of the two study groups. 
 
At the screening visit, patients will be evaluated for trial eligibility and the study 
will be explained. For eligible patients who wish to participate, informed consent will be 
obtained and the patient will receive history and physical exam and will complete 
baseline HRQoL and pain scale surveys. Volumetric scans will be performed and the 
data will be stored. Patients will be randomized by a study coordinator, and will be 
instructed to expect stockings in the mail within 3 weeks. 
 
After stockings are dispensed, patient should call the office to inform the study 
nurse or coordinator of the day they are beginning therapy, and biweekly log will be kept 
as a measure of compliance. 
 
Patients in the study should also complete the Brief Pain Inventory (BPI) before 
randomization (at baseline following enrollment), by phone during week six, and at 
clinical follow-up after completing 90 days of compression therapy. Additionally, patients 
will be assessed on their satisfaction at week six and at 90-day clinical follow-up. This 

Stocking Protocol 
IRB NUMBER: HSC-1M2S-17-0015 
IRB APPROVAL DATE: 03/02/2017 
 
 
 
will be done using the 5-point satisfaction scale with 1 being “very dissatisfied” to 5 
being “very satisfied”. The SF-12 HRQoL instrument will also be completed at 
enrollment, at six weeks and at 90-day follow-up. This will conclude the 90-day 
treatment period. Patients will be re-contacted at six months post-treatment to 
determine whether they are still using their stockings (or have replaced them) or have 
progressed to invasive treatment. After the six-month assessment, the study will be 
concluded and enrollment will be terminated. 
 
Study Conduct 
 
 
1. Screening 
 
 
The PI and research staff will assess patients as possible candidates for 
enrollment based on the inclusion criteria described previously. A member of the 
research team - the PI, a Co-investigator, research coordinator, or research nurse will 
obtain the consent from interested patients who met the preliminary inclusion criteria. 
The consent process will take place during the clinic visit. Patients will be given 
adequate time and education about their condition to ask questions about the protocol 
and research study. Those who wish to participate will be informed they are responsible 
for the cost of the hosiery as it may not be covered by insurance (most plans do not 
cover stockings even though they are required prior to preauthorization for ablation 
therapy). Patients would be responsible for this cost whether or not they are enrolled in 
the trial – no additional cost to the patient will result from trial participation. The 
preoperative baseline pain level, using BPI and HRQoL will be recorded at this time. A 
copy of the signed informed consent shall be provided to the patient, a copy will be 

Stocking Protocol 
IRB NUMBER: HSC-1M3S-17-0015 
IRB APPROVAL DATE: 03/02/2017 
 
 
 
placed in the patient’s hospital chart, and a copy will be kept by the research team. 
Medical/surgical history, vital signs measurements, and standard clinical testing will also 
be performed as per the usual practice for assessment and management of CEAP class 
2-5 venous disease. 
 
2. Quality of life assessment - Brief Pain Inventory 
 
 
The impact of pain on patient’s quality of life will be assessed through a brief pain 
inventory (BPI) that should be done at enrollment, at the six week point during 
compression therapy and at the final clinic visit after 90 days of treatment. The BPI will 
be presented as an easy to comprehend questionnaire for the patients to quantify and 
communicate their pain experience and how it is affecting their life. It is designed such 
that patients with 6th-grade education should be able to complete the questionnaire on 
their own. Question and answers will be provided in a check-box format. The BPI that 
will be used on this study will be the short version. Patients with difficulty reading or who 
are physically unable to complete the questionnaire will be assisted by the research 
team based on their verbal responses to the BPI questions. 
 
3. Enrollment 
 
 
After screening for eligibility, if all inclusion/exclusion criteria are met and the 
patient has consented; the patient will be enrolled in the trial. 
 
4. Randomization and Allocation Concealment 
 
Randomization and allocation concealment will be performed by study personnel 
using a restricted-access randomization file.  The sequence will be generated by a UT 

Stocking Protocol 
IRB NUMBER: HSC-1M4S-17-0015 
IRB APPROVAL DATE: 03/02/2017 
 
 
 
statistician in a random permuted block design and copied to a secure drive accessible 
only to unblinded study personnel. At enrollment patients will be assigned a study ID 
number. The laser scan data will be identified by this study number and noted in the 
CRF.  Depending on the group assignment, either an order for a custom pair of 
stockings will be generated and tagged to the scan data – which will then be transmitted 
to the manufacturer – or the appropriate pair of Sigvaris stockings will be procured. 
After two weeks, the stockings as allocated by randomization will be packed in 
unbranded packaging and mailed to the research subject by trackable means (UPS, 
FedEx, US Postal Service, etc.). The clinical personnel who assess the patients will not 
handle the hosiery and will not see it on the patient. The patient will not know whether 
the stockings are custom or off-the-rack, so the double masking will be maintained. 
 
5. Baseline assessment 
 
 
History, physical exam and review of symptoms will conducted at enrollment and 
captured to an electronic case report form that will be implemented at UT in REDCap. 
The examining physician will draw a diagram of the involved veins for comparison with 
the 90-day examination. Pain assessment and HRQoL will be captured as described 
previously. 
 
6. Follow-up 
 
 
After the initiation visit is completed, the follow-up will be: 
 
i. 
Compression therapy per physician directive throughout 90 days with a 
compliance log to be kept bi weekly. 

Stocking Protocol 
IRB NUMBER: HSC-1M5S-17-0015 
IRB APPROVAL DATE: 03/02/2017 
 
 
 
ii. 
At 6 weeks questionnaire completion via phone. 
 
iii. 
At 90 days clinic follow-up and questionnaire completion 
 
iv. 
At six months after treatment initiation by telephone 
 
7. Termination of enrollment 
 
 
Patient will be considered to have his/her enrollment terminated: 
 
i. 
After completion of the six month telephone survey 
 
ii. 
If any medical/surgical/environmental condition develops that would affect 
or impair primary or secondary outcomes measurements results 
 
iii. 
If the study is terminated 
 
iv. 
If the patient dies 
 
8. Termination of Study 
 
 
i. 
End of study period 
 
ii. 
Unanticipated safety problems that would make continuation unethical 
 
iii. 
If the trial does not look as though it can achieve its enrollment targets 
within two years 
 
 
 
XIII. 
ADVERSE EVENT REPORTING 

Stocking Protocol 
IRB NUMBER: HSC-1M6S-17-0015 
IRB APPROVAL DATE: 03/02/2017 
 
 
 
Patients enrolled in the trial will be instructed to report any unwanted effect at any 
time during the study. For this study, only adverse events that are directly related to the 
use of compression stocking will be reported. Expected adverse effects of compression 
therapy will be described to the patients during the screening/enrollment as well as in 
the informed consent process. Most adverse side effects are minor and may include 
rash, contact dermatitis, discomfort, lack of symptomatic relief, and in rare cases, local 
skin ischemia and breakdown. 
 
Safety monitoring will include assessment of: 
 
 
i. 
Adverse Effects (AE) 
 
ii. 
Vital Signs 
 
iii. 
Wound healing status 
 
iv. 
Pain 
 
v. 
Satisfaction 
 
All parameters will be closely monitored in a continuous manner, as part of our 
standard clinical care. Any abnormalities found will be promptly assessed and described 
in the patient’s medical records. Patients will be instructed to call the clinic if problems 
arise, and will also be assessed at clinic visits. If need be, an immediate unscheduled 
visit shall be arranged if the patient so desires. 
The PI will review AEs as they occur, and requirement for changes to the study 
design or device use will be determined on an ongoing basis. This study does not 
require a DSMB. 
 
 
XIV. 
STATISTICAL ANALYSIS PLAN 

Stocking Protocol 
IRB NUMBER: HSC-1M7S-17-0015 
IRB APPROVAL DATE: 03/02/2017 
 
 
 
A.  Primary Outcomes 
 
 
The trajectory of BPI, HRQoL and Patient Satisfaction scores at 45 and 90 days of 
treatment will be measured by mixed-effects linear models between the groups. 
Appropriate score transformations will be performed as necessary to meet 
distributional assumptions of the tests. Randomization is expected to balance the 
groups with respect to pre-intervention risk factors. 
 
Total time worn over 90 days as reflected in diary entries will be compared by 
Wilcoxon rank-sum test between the two groups.. 
 
A. Secondary Outcomes 
 
 
Additional analyses will be performed to determine whether patient characteristics 
such as calf/ankle ratio and other measurements made using laser scan data show 
differential (interaction) effects in the custom-stocking group vs the off-the-rack 
group. 
 
Progression to ablation will be measured as simple text of proportions (Fisher’s 
Exact test) of those seeking ablative therapy in the custom vs OTR groups. 
 
B. Sample Size Determination 
 
 
C. A sample size of 200 (100 per arm) patients would allow for detection of a difference 
as small as 20% in the proportion of patients with a post-treatment change in QOL. . 
This detection threshold assumes that 30% of the controls experience some positive 
change in HRQoL and 40% of the custom group experience improvement. Larger 

Stocking Protocol 
IRB NUMBER: HSC-1M8S-17-0015 
IRB APPROVAL DATE: 03/02/2017 
 
 
 
differences can be detected with a much smaller sample size, but a larger sample 
will allow us to investigate predictors of improvement such as measurements and 
patient characteristics.3 The relationship between sample size and proportion of 
successes in the custom group is shown in the figure below. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Laser-measuring all subjects (not just those randomized to Custom) will allow us to 
investigate the influence of leg size and shape on likelihood to see improvement in 
HRQoL and satisfaction, and to identify a variety of other patient-specific factors that 
predict improvements in outcome.  Understanding these relationships may allow us 
to tailor therapy towards optimization of predicted outcome, and could, for example, 
help identify a subset of patients for whom progression to ablation therapy may not 
be necessary. 
 
XV. ETHICS 

Stocking Protocol 
IRB NUMBER: HSC-1M9S-17-0015 
IRB APPROVAL DATE: 03/02/2017 
 
 
 
A. Informed Consent Process 
 
 
All eligible patients who meet the inclusion criteria will be consented, if willing, 
after an in-depth description of the study, the study device and potential adverse effects, 
the risks and benefits, follow-up routine, enrollment and termination processes. The 
importance of follow-up will be emphasized; however, the patient will retain the right to 
voluntarily withdraw from the study at any point. It will also be stressed that patient 
confidentiality will be kept at all times during study through de-identification of data. 
 
Information will be stated clearly in a written consent form that will be designed at 
a 6th grade level of understanding. Information will also be presented verbally. A 
member of the research team, either the PI, Co-PI, or co-investigators will obtain the 
consent of the patient or other the legally authorized representative of the patient. The 
consent process will take place during the enrollment clinic visit. The member of the 
team who is obtaining the written consent will describe the research project in its 
entirety and answer the questions of the patient and/or family members should they ask 
any. Sufficient time will be provided to the patient to review the study before making an 
informed decision to participate or decline. Should they decide to participate a copy of 
the signed consent form will be given to the patient and the process will be documented 
in the patients’ medical records and/or study documentation 
 
B. Privacy and Confidentiality 
 
 
The study will be conducted in compliance with all HIPAA guidelines to protect 
patient confidentiality. All sensitive information or patient identifiers will be stored in form 
of a patient linkage file that will link the patient study/trial number to their clinical records 

Stocking Protocol 
IRB NUMBER: HSC-2M0S-17-0015 
IRB APPROVAL DATE: 03/02/2017 
 
 
 
and secured on the Zone 100 drive on specific networked computers of our department. 
Data capture will be performed in REDCap software hosted at the UT-Houston School 
of Biomedical Informatics in a Zone 100 server room. Access to any data pertaining to 
the study will be restricted to approved research team members, the FDA, institutional 
review boards of the University of Texas. 
 
C. Risk/Benefit 
 
 
Risks to participants 
 
There is a small increased risk to the patients by participating in the study in addition to 
a possible chance of breach in patient confidentiality as the study involves evaluation of 
an FDA class one medical device. As detailed in the informed consent, the subjects are 
at some risk of developing adverse events described above, as well as currently 
unknown risks. The devices (stockings) to be used are considered low-risk devices by 
the FDA. In addition, there is risk of an unintentional disclosure of personal health 
information. 
 
Benefits to participants 
 
The patients may receive no direct benefit from participation the study. However, if the 
custom-fitted stockings are superior, the patients in this treatment group will have had 
the benefit of early access to them. 
 
XVI. 
STUDY TIMELINE 
 
 
Considering our group’s monthly average for the given procedures and the 

Stocking Protocol 
IRB NUMBER: HSC-2M1S-17-0015 
IRB APPROVAL DATE: 03/02/2017 
 
 
 
enrollment rates, we estimate recruitment of our sample size will take 2 years. Once the 
follow-up of all enrolled participants is finished, data will be analyzed and published. The 
following is a chronological estimate of the stages: 
 
Stage 1: Patient screening and enrollment    0 - 2 years 
 
Stage 2: Follow-up 
(0.5 – 2.5 years) six months after enrollment 
Stage 3: Data collection and analysis 
1 year 
Stage 4: Presentation and publication period (at the end of data analysis) 
 
 
 
 
XVII. DATA SAFETY MONITORING 
 
 
Given the low risk of these commercially available class-1 devices, DSMB oversight is 
not required. 
 
XVIII. CONFLICT OF INTEREST 
 
 
There is no relationship between the PI or any other research staff member and the 
sponsor. 
 
XIX. 
FUTURE PUBLICATION AND PRESENTATION 
 
 
The results of this study will be analyzed and published after the approval of 
the principal investigator and biostatistician in a peer-reviewed scientific journal and/or 
presented at an international/national scientific conference or meeting regardless of 
outcome. The publication will acknowledge members of the study research group for 
their contributions and will maintain patient data protection. 

Stocking Protocol 
IRB NUMBER: HSC-2M2S-17-0015 
IRB APPROVAL DATE: 03/02/2017 
 
 
 
 
 
 
 
XX. 
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research in palliative care: recommendations of an Expert Working Group of the European 
Association of Palliative Care. J Pain Symptom Manage. 2002; 23 (3): 239–55. 
3. Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.) Hillsdale, 
NJ: Lawrence Earlbaum Associates.