NCT06697925招募中不适用
Prospective Multicenter Observational Study Evaluating the Durability of Closure for Venous Leg Ulcers Following a Randomized, Controlled, Clinical Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Kerecis Ltd.
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Durability of closure
研究概览
简要总结
The goal of this observational study is to determine the durability of closure for venous leg ulcer subjects that achieved closure in the THOR trial.
详细描述
To determine durability of closure (rate of target wound recurrence) of subjects with a closed venous leg ulcer during the THOR clinical trial comparing subjects treated with Intact Fish Skin Graft (IFSG) plus standard of care (SOC) to subjects treated with SOC alone.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Subjects must have participated in the THOR trial and achieved complete closure by the 12-week endpoint.
排除标准
- •Subjects who did not participate in the THOR trial.
- •Subjects who participated in the THOR trial and did not achieve complete closure.
结局指标
主要结局
Durability of closure
时间窗: 12-month follow-up
To demonstrate durability of closure (rate of target wound recurrence) of subjects with a closed venous leg ulcer during the THOR clinical trial comparing subjects treated with Intact Fish Skin Graft (IFSG) plus standard of care (SOC) to subjects treated with SOC alone.
次要结局
未报告次要终点
研究者
研究点 (1)
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