Evaluation of the efficacy (reduction of inflammatory signs suggesting a local infection) and tolerance (emergence and nature of adverse event) of Vashe solution vs Saline solution in the treatment of venous or mixed leg ulcers presenting inflammatory signs suggesting heavy bacterial load
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...)
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.
Parallel
Saline solution
Devicerandomization to saline solution group for local management of venous or mixed leg ulcers
Vashe solution
Devicerandomisation to Vashe solution group for local management of venous or mixed leg ulcers
clinical success at week 4
Clinical success at Week 4, defined as a clinical score ≤ 1.
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