A Retrospective, Multi-center Real-world Study of StimLabs Human Placental Membrane Tissue Used for Treatment in Hard-to-Heal Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- StimLabs
- 入组人数
- 23
- 试验地点
- 5
- 主要终点
- The proportion of target ulcers achieving complete wound closure during the observational period
研究概览
简要总结
This is a retrospective, multi-center observational study to assess real-world outcomes of StimLabs human placental membrane tissue used in the treatment of hard-to-heal wounds, including chronic ulcers, diabetic foot ulcers (DFUs), and venous leg ulcers (VLUs). The collection of retrospective real-world data provides a broad range of experiences related to patient healthcare and treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Consecutive diabetic subjects that received a Relese product application during treatment between May 2023 and April 2025.
排除标准
- •Subjects not receiving an initial Relese application during treatment.
结局指标
主要结局
The proportion of target ulcers achieving complete wound closure during the observational period
时间窗: 1-12 weeks
Determine the percent (%) of target ulcers achieving complete wound closure at 12 weeks.
The Percentage of Treated Target Ulcers Achieving Complete Wound Closure During the Observational Period
时间窗: Data were collected retrospectively from health registries, for up to 12 weeks after the procedure, hence timeframe may exceed the study duration in this outcome measure.
Determine the percent (%) of target ulcers achieving complete wound closure at 12 weeks through the observational period. Target ulcers were defined as all eligible ulcers treated during the observational period. Multiple target ulcers from a single participant were permitted and analyzed individually.
次要结局
- Percent area reduction(1-12 weeks)
- Time to closure for the target ulcer(1-12 weeks)
- Adverse events(1-12 weeks)
- Percent Area Reduction for Treated Ulcers Over 12 Weeks(Data were collected retrospectively from health registries, for up to 12 weeks after the procedure, hence timeframe may exceed the study duration in this outcome measure.)
- Time to Closure for the Treated Target Ulcers(Data were collected retrospectively from health registries, for up to 12 weeks after the procedure, hence timeframe may exceed the study duration in this outcome measure.)