DRKS00009329招募中未知
Assessment of efficacy and safety for a new wound dressing URGO 310 3166 in the local treatment of venous or mixed leg ulcers: a european, randomised clinical trial - CLEANER
aboratoires URGO0 个研究点目标入组 220 人开始时间: 2015年11月9日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 220
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
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one(—)
- 性别
- All
入选标准
- •Patient over 18 years old who has provided his/her written informed consent,
- •Patient who can be monitored by the same investigation team throughout the whole duration of the study,
- •Patient who agrees to wear an effective venous compression system every day, associated with the trial dressing,
- •Leg ulcer with an Ankle Brachial Pressure Index (ABPI) not less than 0.7 and not more than 1.3,
- •Ulcer area Superior or equal to 5 cm2,
- •Ulcer duration Superior or equal to 6 months,
- •Ulcer presenting a the surface wound bed covered with 50% or more by sloughy tissue,
- •Moderately or heavly exudative ulcers.
排除标准
- •Clinical infection on the wound bed
研究者
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