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

NCT02782689 | Terminated

• 1 other identifier: 2014-A00287-40
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Venous Leg Ulcer

Outcome Measures

Primary Outcomes (2)

• Percentage of patients with complete wound closure (100% re-epithelialisation) over the treatment period

  16 weeks

• Nature and frequency of adverse events

  16 weeks

Study Arms (2)

Kit Biflex

EXPERIMENTAL

The Kit Biflex® will be applied according to manufacturer recommendations for 16 weeks or until full healing.

Device: Kit Biflex

Profore

ACTIVE COMPARATOR

The compression system Profore will be applied according to manufacturer recommendations for 16 weeks or until full healing.

Device: Profore

Interventions

Kit Biflex DEVICE

Two-layer reusable compression system

Kit Biflex

Profore DEVICE

Four-layer compression system

Profore

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Thuasne: lead

Study Sites (1)

Thuasne

Levallois-Perret, 92307, France

Location

MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jean-Luc GILLET, MD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2016
• First Posted: May 25, 2016
• Study Start: June 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: April 26, 2018

Record last verified: 2018-04

Locations

FR (1)