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

Venous Leg Ulcer Clinical Trial

— COMPULCE  

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 Details — Status: Terminated

Administrative data

• NCT number: NCT02782689
• Other study ID #: 2014-A00287-40
• Status: Terminated
• Phase: N/A
• First received: May 23, 2016
• Last updated: April 25, 2018
• Start date: June 2014
• Est. completion date: March 2017

Study information

• Verified date: April 2018
• Source: Thuasne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 92
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Device:
• Kit Biflex
Two-layer reusable compression system
• Profore
Four-layer compression system

Locations

Country	Name	City	State
France	Thuasne	Levallois Perret

Sponsors (1)

Lead Sponsor	Collaborator
Thuasne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with complete wound closure (100% re-epithelialisation) over the treatment period		16 weeks
Primary	Nature and frequency of adverse events		16 weeks