NCT01082445已完成3 期
Effects of Prolonged N-acetylcysteine Administration on Foot Ulcer Oxygenation in Diabetic Patients
University of Turin, Italy1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Tissue oxygenation improvement
研究概览
简要总结
The purpose of this study is to determine whether N-acetylcysteine is effective in the treatment or prevention of the foot ulcers in diabetic patients.
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
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 45 and 70 years.
- •Type 1 or 2 diabetes mellitus with foot ulcer (grade 0 stage C according to Texas University Classification).
- •Written informed consent.
排除标准
- •N-acetylcysteine assumption in the 6 months previous to the study.
- •Hypersensibility to acetylcysteine.
- •Neoplasms, severe systemic, hepatic, pulmonary, cardiovascular or renal diseases.
- •Psychiatric diseases or drug abuse problems.
研究组 & 干预措施
N-acetylcysteine
Experimental
50 patients that receive 600 mg of acetylcysteine for 3 times a day.
干预措施: N-acetylcysteine (Drug)
Placebo
Placebo Comparator
50 subjects taking placebo pills 3 times a day
干预措施: Placebo (Drug)
结局指标
主要结局
Tissue oxygenation improvement
时间窗: Basal (time 0) and after 3 months of treatment/observation
次要结局
- Improvement of the endothelial function(Basal (time 0) and after 3 months of treatment/observation)
- Oxidation status reduction(Basal (time 0) and after 3 months of treatment/observation)
研究者
Valentino Martina
Aggregated Professor
University of Turin, Italy
研究点 (1)
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