Multicenter, randomised, open-label, parallel group, controlled study to evaluate the efficacy, tollerability and safety of BioFOAM dressing containing larve of Lucilia sericata in patients with chronic, vascular ulcers with/without evident infection versus standard treatment (idrogel.

INTERVENTION: Pharmaceutical Form: Impregnated pad INN or Proposed INN: LarvE BIOFoam dressing Concentration unit: cm2 square centimeter Concentration type: equal Concentration number: 10‐ CONDITION: Patient with venous ulcers or mixed aetiology ulcers containig necrotic tissue ; MedDRA version: 9.1 Level: LLT Classification code 10066677 Term: Chronic leg ulcer PRIMARY OUTCOME: Main Objective: To compare the clinical effectiveness of a larval therapy dressing with a standard debridement technique (hydrogel) in terms of its effect on time to debridement of leg ulcers. Primary end point(s): The time to debridement of the ulcers Secondary Objective: None INCLUSION CRITERIA: Patients are aged 18 years or above and have a sloughy and/or necrotic leg ulcer (slough and/or necrotic tissue estimated to cover a minimum of 25% of the wound) of purely venous or mixed arterial/venous aetiology. Patients have an ulcer with an area of < 5 cm2. People with diabetes mellitus are eligible to participate provided that their blood sugar is well controlled (HbA1c equal to or less than 10%) and they have venous or mixed aetiology ulcers. People with rheumatoid arthritis are eligible to participate provided they have ulcers that are deemed to be venous in origin. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range