Prospective, randomised, multi-centre, blind-observer, controlled, parallel-group study comparing the efficacy and the safety of DERMAGEN® versus conventionnal treatment in the treatment of diabetic neuropthic foot ulcer

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 388

Inclusion Criteria

•Female or male patient aged = 18
•Patient with documented and stable* type I or II diabetes mellitus
•With diagnosis of neuropathic foot ulcer located on the plantar surface of the forefoot
•Ulcer with a surface area comprised between 1 and 15 cm2 included (after mechanical debridement of the ulcer)
•Palpable pulse evidenced on both feet (presence of dorsalis pedis pulse and posterior tibial pulse) or in absence of one pulse, a Systolic Pressure Index (SPI) by Doppler > 0.9 on the target limb
•Presence of diabetic foot ulcer for at least 4 weeks prior to enrolment
•Patient’s ulcer extending through the dermis without exposure of muscle, tendon, bone, or joint capsule
*means confirmed by HbA1C at least every 4 months

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

Exclusion Criteria

•Typical Charcot’s foot
•Decrease or increase in the size of the ulcer by 50% or more during the run-in period
•Presence of osteitis (eq Br osteomyelitis) at the inclusion visit (evidenced with a radiological lesion facing the wound (bone erosion or disappearance of the cortical bone))
•Clinical evidence of Pedis grade 3, or 4 infection at the inclusion visit
•Patient who cannot have an off-loading method
•Patient with working activity who cannot be on sick-leave during the study period.
•Patient presenting a known allergy to collagen, streptomycin, penicillin and/or products of bovine origin
•Dialysed patient
•Patient suffering from a psychiatric disorder not treated
•Clinical evidence of gangrene on any part of the affected foot
•Patient receiving corticosteroids, NSAIDs, immunosuppressive or cytotoxic agents, all systemic agents that can affect wound repair or any treatment that might interfere with the assessment of the study treatment

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of DERMAGEN® versus the conventional treatment (sterile saline-moistened gauze) for the treatment of patients with diabetic neuropathic foot ulcer. ;Secondary Objective: To evaluate the safety of DERMAGEN®;Primary end point(s): Healing rate (complete wound closure) at week 12

Secondary Outcome Measures

Name	Time	Method

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