NCT00312364已完成2 期
Safety and Efficacy Study of MRE0094 to Treat Chronic, Neuropathic, Diabetic Foot Ulcers
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 322
- 试验地点
- 126
- 主要终点
- Incidence of complete healing of target ulcer at endpoint or 90 days, whichever is earlier.
研究概览
简要总结
This is a clinical research study of an experimental topical drug for the treatment of chronic, neuropathic, diabetic foot ulcers.
Patients participating in the study may receive an active drug (MRE0094), inactive drug (placebo), or a gel used to treat diabetic foot ulcers currently available for sale in the United States. What treatment a patient will receive is determined by chance (like drawing a number from a hat). All patients will receive additional care for diabetic foot ulcers during the study.
Participation in the study can be up to 4½ months.
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
- Double
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
- •Participants included in the study must:
- •Have type 1 or type 2 diabetes mellitus.
- •Have problems with the nerves in their feet.
- •Have an ulcer on the bottom surface of their foot that has been present for 3 weeks or more and is of sufficient size to qualify for the study.
- •Be able to apply study drug to their ulcer, or have a caregiver do it.
- •Be able to visit the doctor regularly during the 4½ month study.
排除标准
- •Participants may not participate in the study if:
- •Their ulcer is caused by bad blood flow to their foot.
- •Their ulcer is infected.
- •They cannot wear a special boot during the study to take pressure off the ulcer.
- •They have certain other diseases, or are using certain types of drugs.
结局指标
主要结局
Incidence of complete healing of target ulcer at endpoint or 90 days, whichever is earlier.
次要结局
- Time to closure and percent reduction in surface area of the target ulcer.
- Incidence, intensity, and seriousness of adverse events. Changes in irritation scores.
研究者
研究点 (126)
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