ISRCTN86386707已完成不适用
An open, randomized, (out-patient) clinical study into the effectiveness, durability and cost efficiency of Tiscover® (cultured, autologous skin) for chronic leg wounds (ulcera cruris)
VU University Medical Centre (VUMC) (Netherlands)0 个研究点目标入组 100 人开始时间: 2006年1月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Ulcus cruris venosum, ulcus cruris arterio(lo)scleroticum and ulcers of mixed origin
- •2. Non-vital ulcers which exist for at least 5 months and which do not respond to adequate compression therapy and local wound treatment
- •3. Ulcers between 5 and 100 square cm
- •4. Signed informed consent
- •5. Ankle/arm index >0.7
排除标准
- •1. Diabetic foot ulcers
- •2. Serious co-morbidity which decreases the life expectancy to less than 2 years
- •3. Use of high doses of corticosteroids and/or cytostatic drugs (>20 mg/day)
- •4. Diagnosed Penicillin allergy
- •5. Serious infection of the ulcer bed at time t = 0
- •6. Disturbances of psychiatric nature where the following of medical advice becomes a problem
- •7. Declining clinical treatment and/or follow up visits
研究者
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