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

April 25, 2018 updated by: Thuasne

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).

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Levallois Perret, France, 92307
        • Thuasne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inpatients or outpatients.
  • Agreeing to wear a multilayer compression system throughout the study period.
  • Presenting with an active venous leg ulcer: Duration between 1-24 months (whether a new ulcer or a recurrent ulcer); Surface area between 2-50 cm2; Venous, superficial or post-thrombotic ulcer confirmed by Doppler ultrasonography (dated within six months).
  • With ankle circumference between 18-25 cm to allow the laying of the compression system.
  • Able to follow the study instructions.
  • Having read the information sheet and dated and signed the informed consent form.
  • Covered by a health insurance system.

Exclusion Criteria:

  • Scheduled surgery for the ulcer during the 16 weeks following inclusion.
  • Clinical superinfected ulcer not controlled oral antibiotics.
  • Malignant ulcer.
  • Ulcer surface totally covered with dry fibrinous tissue or covered with black necrotic plaque on over 10% of its surface.
  • Deep Vein Thrombosis within the last 3 months.
  • Corticosteroids treatment (equivalent to more than 10 mg per day of prednisolone) ongoing or planned during the study.
  • Radiotherapy, chemotherapy or immunosuppressive therapy ongoing or planned during the study.
  • Erysipelas and lymphangitis.
  • Lower extremity arterial disease or microangiopathy (Ankle Brachial Pressure Index <0.8 or> 1.3).
  • Uncontrolled non-insulin dependent diabetes (HbA1c> 8%).
  • Insulin-dependent diabetes.
  • Confined to bed.
  • With any uncontrolled severe and progressive disease.
  • With a known or suspected hypersensitivity to any of the components of the study devices.
  • Who had participated in a previous clinical study within the past 3 months.
  • Pregnant women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Kit Biflex
The Kit Biflex® will be applied according to manufacturer recommendations for 16 weeks or until full healing.
Device: Kit Biflex
Two-layer reusable compression system
ACTIVE_COMPARATOR: Profore
The compression system Profore will be applied according to manufacturer recommendations for 16 weeks or until full healing.
Device: Profore
Four-layer compression system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with complete wound closure (100% re-epithelialisation) over the treatment period
Time Frame: 16 weeks
16 weeks
Nature and frequency of adverse events
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thuasne

Investigators

  • Principal Investigator: Jean-Luc GILLET, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

March 1, 2017

Study Registration Dates

First Submitted

May 23, 2016

First Submitted That Met QC Criteria

May 24, 2016

First Posted (ESTIMATE)

May 25, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2018

Last Update Submitted That Met QC Criteria

April 25, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A00287-40

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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