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临床试验/DRKS00009329
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

发起方
aboratoires URGO

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