EVALUATION OF THE EFFICACY AND TOLERANCE OF VASHE SOLUTION VERSUS SALINE SOLUTION IN THE TREATMENT OF VENOUS OR MIXED LEG ULCERS PRESENTING INFLAMMATORY SIGNS SUGGESTING HEAVY BACTERIAL LOAD

This study is carried out in United States of America in around 10 investigator sites. A total of 102 patients meeting the eligibility criteria will be included

Inclusion criteria

• Adult patient, at least 18 years of age or older who has provided free, written, and informed consent,
• Patient who has already worn compression therapy in the past and agrees to wear the two-layer compression system during the whole treatment period,
• Patient presenting a venous or mixed leg ulcer predominantly of venous origin (ABPI between ≥0.8≤1.3,
• Leg ulcer presenting at least 3 inflammatory signs (e.g pain, erythema...)
• Target leg ulcer located at least 3 cm from the edge of another wound.

Exclusion criteria

• Pregnant or breastfeeding patient,
• Patient already participating in another clinical trial, except observational trial
• Patient with epifascial arterial bypass (superficial arterial bypass)
• Patient suffering from phlegmatia coerulea dolens, septic phlebitis, acute deep vein thrombosis (DVT), defined as the first 10 days from onset of symptoms, or any DVT for which compression is considered by the Investigator to be contraindicated.
• Patient receiving or having received systemic antibiotics within the ten days prior to inclusion in the investigation, regardless of therapeutic class or indication,
• Cancerous wound.