EUCTR2009-014276-22-PL进行中（未招募）不适用
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
aboratoires Genevrier0 个研究点目标入组 388 人开始时间: 2009年10月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 388
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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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 ulcerDiabetic neuropathic foot ulcerMedDRA version: 12.0Level: LLTClassification code 10012664Term: Diabetic foot ulcerEUCTR2009-014276-22-CZaboratoires Genevrier388
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