NCT01891760已完成3 期
A Prospective, Multi-center, Longitudinal, Cohort Study of Dermagraft in Subjects With Venous Leg Ulcers: A Long-term Follow-up to the DEVO-Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 56
- 主要终点
- The incidence of study ulcer recurrence
研究概览
简要总结
- Observe the long-term (1-year) outcomes of Dermagraft, compared with conventional treatment of four-layer compression bandaging therapy alone, in subjects who completed the ABH-Dermagraft-001-08 study.
- Study Hypothesis: N/A (Long-term follow-up study)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Subject has completed study ABH-Dermagraft-001-08
- •Subject understands study requirements
- •Subject is available to participate in the 1 year-long observational follow-up.
排除标准
- •Subject who withdrew or was terminated from ABH-Dermagraft-001-08 before completion
- •Subject is not available for the 1 year-long observational period.
- •Subject has any condition(s) which seriously compromises the subject's ability to complete the study
结局指标
主要结局
The incidence of study ulcer recurrence
时间窗: 1 year
次要结局
- Incidence of complete study ulcer healing(1 year)
- Incidence of study ulcer infection-related events(1 year)
- Time to study ulcer recurrence(1 year)
- Change in ulcer size(1 year)
- Time to study ulcer healing(1 year)
研究者
研究点 (56)
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