Case Study Documentation of Subjects With Either Diabetic Foot Ulcers or Venous Stasis Ulcers Being Treated With OASIS
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Healthpoint
- 入组人数
- 13
- 试验地点
- 6
- 主要终点
- Percent Wounds Closed
研究概览
简要总结
OASIS Wound Matrix (Oasis) will be applied to wounds, with sequential biopsy of healing wounds to explore the mechanism of action.
详细描述
Wound types will be Diabetic Foot Ulcers (DFU) and Venous Stasis Ulcers (VSU).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Diabetic foot ulcer (DFU) or venous stasis ulcer (VSU) of the leg, with certain restrictions on size, duration and underlying health
排除标准
- •Contraindications or hypersensitivity to the use of the study medications or their components
研究组 & 干预措施
OASIS Wound Matrix (Oasis)
This is a single arm study with only the test article Oasis used on all subjects
干预措施: OASIS Wound Matrix (Device)
结局指标
主要结局
Percent Wounds Closed
时间窗: baseline and 12 weeks
Wound healing was assessed weekly, spaced 7 +/- 1 day apart, up to 12 weeks or until the wound healed, whichever occurred first. The outcome value was based on the percent of wounds which were closed at the end of the study (at 12 weeks). The percent wounds closed were calculated for each wound type: Diabetic Foot Ulcers (DFU) and Venous Stasis Ulcers (VSU).
Decrease in Wound Area From Baseline After 12 Weeks of Treatment or Until Wound Closure, Whichever Occurred First.
时间窗: Baseline and weekly up to 12 weeks
Wound measurements were made weekly, spaced 7 +/- 1 day apart, up to 12 weeks or until the wound healed, whichever occurred first. The final measurement taken was subtracted from the baseline to assess the decrease in wound area after treatment. Final calculation is mean baseline measurement minus final measurement at 12 weeks (or when wound healed, whichever occurred first)
次要结局
未报告次要终点