Diabetic neuropathic foot ulcer MedDRA version: 12.0 Level: LLT Classification code 10012664 Term: Diabetic foot ulcer
Conditions
Interventions
Product Name: DERMAGEN
Product Code: DERMAGEN
Pharmaceutical Form: Living tissue equivalent
INN or Proposed INN: Human foreskin fibroblasts
Current Sponsor code: DERMAGEN
Concentration unit: U unit(s)
Sponsors
Laboratoires Genevrier
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To evaluate the safety of DERMAGEN®;Primary end point(s): Healing rate (complete wound closure) at week 12;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. | — |
Countries
Czech Republic, Poland
Outcome results
None listed