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

This is an interventional treatment trial for Diabetic Foot Ulcer(s) focused on measuring Patient Read More

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