NCT00207818已完成1 期
Treatment of Cutaneous Ulcers With a Novel Biological Dressing
CHU de Quebec-Universite Laval2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 1999年9月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- wound closure
研究概览
简要总结
The aim of the study is to evaluate the effect of a biological dressing on the healing process of venous ulcers. The dressing is a reconstructed skin substitute made with the patients own cells.
详细描述
The hypothesis of this trial is that the cutaneous model SASS, a dermal epidermal skin substitute, created by the LOEX could be as high-performant, or even better, than the one's already existent in North America for the wound care. We anticipate showing on 6 patients that ulcer that did not close with conventional treatment, will heal or at least improve with this treatment.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women from 18 to 85 years old
- •Have a venous ulcer or a mixed ulcer
排除标准
- •Diabetes Mental deficiency Hepatitis holder (A-B-C) HIV positive Pregnancy or lactation Corticosteroids therapy Radiotherapy Chemotherapy
结局指标
主要结局
wound closure
次要结局
- % of healing at 6 months of treatment
研究者
研究点 (2)
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