EUCTR2009-015749-22-DE进行中（未招募）1 期
A prospective, monocentric clinical trial with adalimumab for topical treatment in chronic wounds - ADATOP
niversity of Leipzig0 个研究点目标入组 18 人开始时间: 2010年9月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
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
- •- at least one chronic wound without signs of infection
- •- age >=50 years
- •- at least 6 months peristence without significant recovery despite optimal wound care, the wound must measure between 2.24cm2 and 64cm2
- •- written informed consent
- •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 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- pregnant and nursing women,
- •- pre-existing severe hepatic or renal insufficiency
- •- pre-existing of hepatitis
- •- chronic severe focus of infection
- •- severe wound infection
- •- known hypersensitivity to Adalimumab or other components of the IMP
- •- signs of latent or active tuberculosis
- •- decompensated cardiac insufficiency (NYHA III/IV)
- •- lack of treatment compliance
- •- active demyelinating or other neurological disorder
- •- malignant or lymphoproliferative disorder
- •- known autoimmune disorder
- •- consumption of other immunosuppresive drugs
- •- women of child bearing potential (< 2 years after last menstruation)
- •- concurrent participation in other studys
- •- individuals dependent on investigator
研究者
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