NCT01629199已完成3 期
The Clinical Trial for Evaluation of Efficacy and Safety of rhEGF(Recombinant Human Epidermal Growth Factor) in Diabetic Foot Ulcer Patients With Uncontrolled Diabetes Mellitus.
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- At 12 weeks, wound closure rate of diabetic foot ulcers
研究概览
简要总结
The purpose of this clinical trial is to evaluate the safety and efficacy of rhEGF (recombinant human Epidermal Growth Factor) in diabetic foot ulcer patients with uncontrolled diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
rhEGF(recombinant human Epidermal Growth Factor)
Experimental
BID
干预措施: rhEGF(recombinant human Epidermal Growth Factor) (Drug)
placebo
Placebo Comparator
BID
干预措施: placebo of rhEGF(recombinant human Epidermal Growth Factor) (Drug)
结局指标
主要结局
At 12 weeks, wound closure rate of diabetic foot ulcers
时间窗: 12 weeks from the start day of treatment (But, the study can be finished before 12 weeks)
次要结局
- Time to reach complete wound closure(12weeks)
- average size reduction of diabetic ulcer(12 week)
研究者
研究点 (1)
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