NCT02583958Unknown不适用
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
适应症
试验速览
- 阶段
- 不适用
- 试验地点
- 2
- 主要终点
- Relative regression of wound surface area
研究概览
简要总结
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.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 > or equal to 5cm2,
- •Ulcer duration > or equal to 6 months,
- •Ulcer presenting a the surface wound bed covered with 50% or more by sloughy tissue,
- •Moderately or heavily exudative ulcers.
排除标准
- •Clinical infection on the wound bed.
结局指标
主要结局
Relative regression of wound surface area
时间窗: week 20
次要结局
- Percentage of debrided wounds(at each clinical evaluation up to 20 weeks)
- Patient's Quality of Life(at inclusion visit and at week 20 or at the end of study treatment)
- Occurrence of adverse events as assessed by the investigator according to a classification MedDRA(between inclusion and week 20)
研究者
研究点 (2)
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