NCT01154374已完成2 期
A Phase II, Randomized, Controlled, Two-Center Pilot Study of the Safety and Efficacy of Topically Applied MEBO® Wound Ointment Compared to Standard of Care in Subjects With Diabetic Foot Ulcers
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- The incidence of complete healing of the target ulcer.
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with diabetic foot ulcers (DFUs).
详细描述
This is a phase II, randomized, controlled, two-center pilot study designed to assess the safety and efficacy of MEBO in the treatment of subjects with DFUs. Subjects meeting entry criteria will be randomly assigned in a 1:1 ratio for up to 8 weeks of treatment with either MEBO or SOC.
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
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female ≥18 years of age
- •Able and willing to provide informed consent
- •Able and willing to comply with protocol visits and procedures
- •Target ulcer duration of ≥4 weeks
排除标准
- •Ulcer of a non-diabetic pathophysiology
- •Known or suspected allergies to any of the components of MEBO
- •Malignancy on target ulcer foot
- •Non-compliance in the screening or run-in period
研究组 & 干预措施
MEBO Wound Ointment
Experimental
Topical application twice daily
干预措施: MEBO Wound Ointment (Drug)
Standard of Care (sterile saline moistened gauze)
Active Comparator
Topical application twice daily
干预措施: Standard of Care (sterile saline moistened gauze) (Procedure)
结局指标
主要结局
The incidence of complete healing of the target ulcer.
时间窗: 8 weeks of treatment period
次要结局
- Time required to achieve complete healing (days).(8 weeks treatment period)
- Absolute and percentage change in ulcer surface area from baseline to endpoint.(8 weeks treatment period)
研究者
研究点 (2)
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