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Clinical Study to Assess Efficacy and Safety of a New Compression System in the Management of Venous Leg Ulcers — COMPULCE  

Venous Leg Ulcer Clinical Trial

Official title:
Evaluation of Efficacy and Safety of the 2-layer Compression System Kit Biflex® Versus the 4-layer Compression System PROFORE® in the Management of Venous Leg Ulcers (Stage C6).

Clinical Trial Summary

The primary objective of this study is to demonstrate the non-inferiority of the 2-layer compression system Kit Biflex® with regard of the 4-layer compression system PROFORE® in the treatment of venous leg ulcers in terms of complete healing at 16 weeks.

Clinical Trial Description

This trial is a multicentre, randomized, comparative, open label clinical study conducted in vascular medicine centres in France, with 2 parallel groups of 100 patients each. The study will be conducted in patients suffering from venous leg ulcer (stage C6 of the CEAP classification for chronic venous disorders).

The patients will be randomised at the inclusion: they will receive with either Kit Biflex® or the reference device (Profore®) for maximum 16 weeks (or until full healing).

Investigator assessments are planned every 4 weeks +/- 3 days, for 16 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02782689
Study type Interventional
Source Thuasne
Contact
Status Terminated
Phase N/A
Start date June 2014
Completion date March 2017
View Details
See also
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