A Clinical Study to Assess a Compression Device in Patients With Venous Leg Ulcers
NCT ID: NCT02561013
Last Updated: 2015-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2015-09-30
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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3M™ Coban™ Custom Fit Compression System
3M™ Coban™ Custom Fit Compression System will be custom-fitted at first subject visit and will thereafter be applied and removed daily by the study subject. It will be worn throughout the day by the study subject and removed before bedtime. It will provide therapeutic compression for edema control to help in the healing of venous leg ulcers.
3M™ Coban™ Custom Fit Compression System
3M Coban™ Fit is a compression system that consists of two components: 1. A Compression Stocking and 2. Coban™ Fit Sleeve.
The stocking provides compression to the foot and improves wearing comfort in the calf area under the sleeve. The compression sleeve is intended to provide the therapeutic compression to the calf, with the initial fitting to be done by a health-care professional. The compression sleeve is customized according to the anatomy of the patient's leg; both components are designed to be used together.
Profore
Profore multi-layer compression bandaging system will be applied at the first subject visit and will be worn by the study subject continuously for 7 days, at which time it will be replaced with a new system, or, in the case of a product or non-product reason, replaced before 7 days. It will provide therapeutic compression for edema control to help in the healing of venous leg ulcers
Profore
PROFORE is a multi-layer compression bandaging system developed to apply sustained graduated compression for the management of venous leg ulcers and associated conditions. Multi-layer compression bandaging is the first choice in treatment for venous leg ulcers.
Interventions
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3M™ Coban™ Custom Fit Compression System
3M Coban™ Fit is a compression system that consists of two components: 1. A Compression Stocking and 2. Coban™ Fit Sleeve.
The stocking provides compression to the foot and improves wearing comfort in the calf area under the sleeve. The compression sleeve is intended to provide the therapeutic compression to the calf, with the initial fitting to be done by a health-care professional. The compression sleeve is customized according to the anatomy of the patient's leg; both components are designed to be used together.
Profore
PROFORE is a multi-layer compression bandaging system developed to apply sustained graduated compression for the management of venous leg ulcers and associated conditions. Multi-layer compression bandaging is the first choice in treatment for venous leg ulcers.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Does the subject have an active venous leg ulceration? If multiple ulcers are present, the investigator will need to select a single ulcer of the study leg that is \> 2cm apart from any other ulcer?
3. Does the subject have an ulcer size between 1cm2 and 12cm2?
4. Does the subject have an ABPI between 0.8 and 1.3 that was taken within the past 28 days?
5. Is the subject ambulatory?
6. Is the subject or family member willing to self-manage the venous leg ulcer therapy at home in collaboration with the medical staff, including the ability to properly readjust the closure straps as indicated by tension indicators, and apply new dressings when needed?
7. Is the subject able to understand questionnaire items and action items (e.g., Subject Diary)?
8. Is the subject willing to give written informed consent, including permission to take photographs of the study leg?
Exclusion Criteria
2. Does the subject have decompensated heart insufficiency NYHA Class IV, ACC.AHA Stage D?
3. Does the subject have septic phlebitis?
4. Does the subject have severe deep vein thrombosis (phlegmasia cerulea dolens) and other conditions contraindicated according to established guidelines and local procedures?
5. Does the subject have known hypersensitivity to any of the component materials?
6. Does the subject have a suspected clinical infection of the ulcer or any other systemic infection (requiring antibiotics)?
7. Is the subject scheduled for surgery for the ulcer during the 12 weeks following inclusion?
8. Does the subject have a hospital stay planned for the 12 weeks following inclusion?
9. Does the subject have a suspected or confirmed cancerous ulceration?
10. Does the subject have severe peripheral sensitive neuropathy?
11. Is the subject participating in any other prospective study interfering with this study?
12. Does the subject have any medical condition which in the professional opinion of the investigator disqualifies the subject from enrollment into the study?
13. Does the subject have a history of noncompliance to therapies?
21 Years
ALL
No
Sponsors
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3M
INDUSTRY
Responsible Party
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Principal Investigators
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Patrick J Parks, MD, PhD
Role: STUDY_DIRECTOR
3M Critical & Chronic Care Division
Locations
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Institute for Advanced Wound Care
Montgomery, Alabama, United States
HealthEast Care System
Saint Paul, Minnesota, United States
Jobst Vascular Institute
Toledo, Ohio, United States
Lawson Health Research Institute
London, Ontario, Canada
Calea Ltd
Mississauga, Ontario, Canada
Countries
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Other Identifiers
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05-013293
Identifier Type: -
Identifier Source: org_study_id