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

Study Overview
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Brief Summary
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The main purpose of this trial is to demonstrate that the new dressing is more effective than the current dressing in the local treatment of chronic foot ulcers in diabetic patients.

Official Title
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Assessment of the Efficacy and Safety of a New Wound Dressing in the Local Treatment of Diabetic Foot Ulcers: a Prospective, Randomised, Controlled, Double-blind, European Multicentre Clinical Trial

Conditions
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Diabetic Foot Ulcer(s)

Intervention / Treatment
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* Device: Urgo 310 3113
* Device: Placebo URGO 310 3113 dressing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: URGO 310 3113 dressing - new<br>flexible, conformable, non-adhesive and non-occlusive lipido-colloid matrix that does not adhere to the wound. | Device: Urgo 310 3113<br>* URGO 310 3113 dressing may be changed every 2 to 4 days, and left in place for up to 7 days, depending on the level of exudate and the wound condition<br>|
| Placebo Comparator: URGO 310 3113 dressing<br>flexible, conformable, non-adhesive and non-occlusive lipido-colloid matrix that does not adhere to the wound. | Device: Placebo URGO 310 3113 dressing<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of complete wound closure |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete wound closure |  |  | 
| Change in wound surface area |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient