Safety and Efficacy Study of MRE0094 to Treat Large, Single or Multiple, Chronic, Neuropathic, Diabetic Foot Ulcers
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 16
- 试验地点
- 19
- 主要终点
- Systemic exposure to topical MRE0094 measured by plasma concentrations of MRE0094.
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. The purpose of the study is to determine the safety of the experimental drug when applied to large, diabetic foot ulcers. The study will also determine if the experimental drug can safely promote healing of diabetic foot ulcers better than standard treatments currently available to doctors.
Patients participating in the study may receive an active drug (MRE0094) or inactive drug (placebo). 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 a large ulcer or multiple ulcers 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 an off-loading device during the study to take pressure off the ulcer.
- •They have certain other diseases, or are using certain types of drugs.
研究组 & 干预措施
1
干预措施: MRE0094 (Drug)
2
干预措施: Vehicle gel (Drug)
结局指标
主要结局
Systemic exposure to topical MRE0094 measured by plasma concentrations of MRE0094.
时间窗: Baseline (Day 1) to endpoint or 90 days, whichever is earlier
Incidence, intensity, and seriousness of adverse events (AEs).
时间窗: Baseline (Day 1) to endpoint or 90 days, whichever is earlier
Changes in irritation scores.
时间窗: From baseline to the various treatment visits
Changes in electrocardiograms (ECGs), vital signs, and clinical laboratory values.
时间窗: Baseline, Day 50, and Day 90 (EGCs); from baseline to the various treatment visits (vital signs and lab values)
次要结局
- Incidence of complete healing of target ulcer(At endpoint or 90 days, whichever is earlier)
- Time to closure and percent reduction in surface area of the target ulcer.(From baseline (Day 1) to the various treatment visits)