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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 fo venous leg ulcers

Recruiting
Conditions
treatment of venous leg ulcer
10047043
10057165
Registration Number
NL-OMON31099
Lead Sponsor
3M Deutschland GmbH, Medical Markets Laboratory
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
60
Inclusion Criteria

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.

Exclusion Criteria

Subjects with an ABPI < 0.8 as measured within four weeks prior enrollment

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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