NCT03126396已完成不适用
Assessment of Efficacy, Tolerance and Acceptability of Urgo 310 3166 Dressing in the Treatment of Local Venous or Mixed Leg Ulcers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Efficacy - % of Wound Area Regression (WAR
研究概览
简要总结
Assessment of efficacy & tolerance of Urgo 310 3166 dressing in the treatment of local venous or mixed leg ulcers.
详细描述
Assessment of efficacy, tolerance and acceptability of Urgo 310 3166 dressing in the treatment of local venous or mixed leg ulcers: multicenter trial, conducted in France.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 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 between 3 and 20 cm2
- •Ulcer duration between 3 and 18 months,
- •Ulcer presenting a surface wound bed covered with 50% or more by granulation tissue
- •Moderately or heavily exudative ulcers.
排除标准
- •A. Clinical infection on the wound bed.
结局指标
主要结局
Efficacy - % of Wound Area Regression (WAR
时间窗: at week 12
% of Wound Area Regression (WAR), as a measure of efficacy
次要结局
未报告次要终点
研究者
研究点 (1)
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