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 Venous Leg Ulcers
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Incidence of complete healing of the target ulcer within the 8-week treatment period.
研究概览
简要总结
This is a Phase II, randomized, controlled, two-center pilot study designed to assess the safety and efficacy of MEBO in the treatment of 14 subjects with VLUs. 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 (7 subjects per treatment arm).
详细描述
To assess the safety and efficacy of MEBO in the treatment of 14 subjects with VLUs. 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 (7 subjects per treatment arm).
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 —（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.
- •A full-thickness VLU that has been open continuously for ≥4 weeks and ≤1 year.
排除标准
- •Ulcer of a non-venous hypertensive pathophysiology.
- •Known or suspected allergy to any of the components of MEBO.
- •Malignancy on target ulcer limb.
- •Received another investigational device or drug within 30 days of enrollment.
- •Non-compliance in the screening or run-in period.
研究组 & 干预措施
MEBO Wound Ointment (MEBO)
Topical application once a day
干预措施: MEBO Wound Ointment (MEBO) (Drug)
Standard of Care
Application of Profore multilayer compression bandage system
干预措施: Standard of Care (Procedure)
结局指标
主要结局
Incidence of complete healing of the target ulcer within the 8-week treatment period.
时间窗: 8 week treatment period
次要结局
未报告次要终点