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

• 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.