Randomized Clinical Trial (RCT) to Compare the Efficacy of Coban 2 Versus SSB in the Treatment of Venous Leg Ulcers

Study Overview
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Brief Summary
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The study purpose is to compare healing rates, cost effectiveness, quality of life and safety of 12 week compression therapy for the treatment of venous leg ulcers with the 3M™ Coban™ 2 Layer Compression System versus short-stretch compression bandage.

Official Title
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Randomized Controlled Clinical Study to Assess the Clinical Efficacy of the 3M™ Coban™ 2 Layer Compression System Compared to a Short-stretch Compression Bandage in the Treatment of Venous Leg Ulcers

Conditions
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Venous Ulcer

Intervention / Treatment
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* Device: Coban 2
* Device: SSB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females, age 18 years or older Subjects having a venous leg ulcer (stage C6 according CEAP classification, venous pathology proved by the presence of reflux (Pr)), which is at least 1 cm in any dimension but not larger than 10 cm in any dimension and has at least 5 cm distance to additional ulcers. Subjects who are co-operative, willing to give written informed consent prior to study entry, and willing to comply with the study protocol. Subjects who are able to understand and answer questionnaire items. Subjects who can walk (with or without a walking aid). Subjects who have an ABPI (ankle brachial pressure index) of treated leg greater or equal to 0,8 as measured within four weeks prior to enrollment. Subjects with venous incompetence as defined by reflux longer than 1,0 second in at least one of the following sites: groin [femoral vein, junction of GSV], mid thigh medial [GSV], hollow of the knee [popliteal vein, junction of SSV], mid calf [SSV] in the standing position, measured by Doppler, preferably by duplex within the last 12 month without following active treatment of venous reflux. Exclusion Criteria: Subjects with an ABPI < 0.8 as measured within four weeks prior to enrollment. Subjects whose condition, in the opinion of the investigator, does not require or allow for compression therapy. Subjects where the potential study ulcer is infected, i.e. showing signs of clinical infection (not contamination) as evidenced by purulent, malodorous, or recent increase in drainage and/or peri-wound erythema or elevated temperature. Subjects receiving any systemic antibiotics. Subjects with diagnosed cancerous ulceration. Subjects with diabetic foot ulcers (do not exclude diabetics). Subjects with circumferential wounds. Subjects who started or significantly changed treatment with mood altering substances (e.g. antidepressant drugs) within two weeks prior to enrollment. Subjects who are participating in any prospective clinical study that can potentially interfere with this study. Subjects who are, in the opinion of the clinical investigator, unsuitable for enrollment in this study, for reasons not specified in the exclusion criteria. Subjects with known allergies against the following products: Coban 2 Layer Compression System, Rosidal K, Rosidal soft, Tegaderm Foam, Cavilon NSBF

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Coban 2 Layer Compression System | Device: Coban 2<br>* Bandages will be changed after a wear time of seven days, or in case of product or non-product related reason, which would require a dressing or bandage change.<br>* Other names: Coban 2 Layer Compression System;|
| Active Comparator: 2<br>Short-Stretch Bandage | Device: SSB<br>* Bandages will be changed after a wear time of seven days, or in case of product or non-product related reason, which would require a dressing or bandage change.<br>* Other names: Rosidal soft;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - venous leg ulcer healing |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - wound size reduction - HRQoL - treatment-cost based on material consumption and visit costs - sub-bandage pressure measurements - AE/SAE |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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compression therapy, venous leg ulcer, sub bandage pressure