DRKS00000583进行中（未招募）2 期
A prospective, monocentric clinical trial with adalimumab for topical treatment in chronic wounds - ADATOP
niversität Leipzig0 个研究点目标入组 4 人开始时间: 2010年11月3日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 50 Years 至 one（—）
- 性别
- All
入选标准
- •at least one chronic wound without signs of infection. At the time point of study inclusion the wound must measure between 2,25 cm2 and 64 cm2.
- •- age =50 years
- •- at least 6 months existence without significant recovery although optimal wound care
- •- written informed consent
排除标准
- •- pregnancy and nursing women,
- •- presence of severe hepatic insufficiency or renal insufficiency
- •- presence of hepatitis
- •- chronic severe focus of infection
- •- severe wound infection
- •- known hypersensitivity to Adalimumab or other components of IMP
- •- signs of latent or active tuberculosis
- •- clinically decompensated heart failure (NYHA III/IV),
- •- inusfficient compliance
- •- active demyelinating or other neurological disorder
- •- malignant or lymphoproliferative disorder
- •- known autoimmune disorder
- •- intake of other immunodepressive drugs
- •- women of child bearing potential (< 2 years after last menstruation)
- •- concurrent participation in other clinical trials
- •- persons dependent on investigator
研究者
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