Assessment of the Efficacy and Safety of a New Wound Dressing in the Local Treatment of Diabetic Foot Ulcers

Inclusion Criteria: * Male or female over 18 years old who has provided his/her written informed consent * Patient covered by the French national insurance system * Patient with Type 1 or Type 2 diabetes mellitus with glycated hemoglobi(HbA1c) levels ≤ 10% (assayed in the previous 3 months. If not available, this assay must be performed during the run-in period) * Inpatient or outpatient who can be monitored by the same investigating team throughout the duration of the study * Patient who agrees to wear the prescribed off-loading system every day, associated with the test dressing * DFU with adequate arterial blood supply in the target limb DFU grade I-C or II-C as defined by the University of Texas Diabetic Wound Classification * Neuropathy confirmed by loss of protective sensation to monofilament test (Semmes-Weinstein 5.07 monofilament) * DFU located on the toe or on the lateral, dorsal or plantar side of the foot * Target DFU surface area between 1 cm² and 30 cm², following debridement DFU duration between 1 and 24 months * No local clinical infection (as defined by IDSA/IWGDF criteria) for any wound (target DFU or not) on lower limbs * DFU adequately debrided Exclusion Criteria: * Pregnant or breast-feeding woman or woman of childbearing potential not using effective means of contraception * Patient who took part in another clinical trial in the previous month or who is to take part in another clinical trial in the 20 weeks following inclusion * Patient with any known intolerance or allergy or reported adverse reaction to one of the components of the trial dressings * Patient who has undergone surgery or surgical revascularization (vascular reconstruction or angioplasty) in the previous 2 months * Patient who has presented an acute ischemic event (Acute Myocardial Infarction (AMI) or stroke) in the 3 months before inclusion * Patient with Severe kidney failure, defined as requirement for dialysis * Patient with a systemic infection not controlled by suitable antibiotic treatment * Patient with known osteomyelitis * Patient with leg ulcer(s), regardless of limb * Patient with wounds other than the target DFU located on the heel or on the interdigital part of the foot * Patient with an active neoplastic condition, treated by radiotherapy, chemotherapy, hormone therapy or immunosuppressant agents * Patient treated for a chronic disease requiring high doses of systemic corticosteroids (≥ 40 mg.d-1 of prednisolone or equivalent) * Patient with a severe illness that might lead to premature withdrawal from the trial * DFU for which surgery or surgical revascularization is planned at any time during the study * Deep DFU defined as stage III or IV (University of Texas Diabetic Wound Classification) * DFU clinically infected as defined by IDSA/IWGDF criteria * DFU with more than 20% of its surface area covered by black necrotic tissue following debridement * DFU located on an amputation stump * DFU with neoplastic component