A Retrospective, Single-center Case Series of StimLabs Dehydrated Human Umbilical Cord Particulate Used for Treatment in Acute and Chronic Wounds
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 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
The purpose of this observational case series is to assess the use of Corplex P as a resorbable particulate device used to cover, protect, and provide a moist wound environment when added to the standard of care treatment of hard-to-heal wounds.
详细描述
This is a retrospective, single-center observational case series to assess real-world outcomes of StimLabs dehydrated human umbilical cord particulate used in the management of hard-to-heal wounds, including acute and chronic ulcers. This case series will include real-world data from up to 10 subjects at one participating site. The Corplex P product has been utilized in a variety of patients attending wound clinics for management of partial and full-thickness wounds, pressure ulcers, venous leg ulcers (VLU), diabetic foot ulcers (DFUs), chronic vascular ulcers, and surgical wounds. The device is intended to cover, protect, and provide a moist wound environment. Medical records will be reviewed for subjects who received the Corplex P product, and data will be collected from baseline, first presentation, treatment, and follow up data. Data summaries will review wound closure, percent are reduction in wound size over treatment time, number of device applications required during treatment, time to wound closure, and adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •All consecutive subjects that received a Corplex P device application during wound management in the following retrospective cohort between February 2024 and November 2025.
排除标准
- •Subjects not receiving an initial Corplex P application during treatment
研究组 & 干预措施
Retrospective Corplex P
Retrospective case review of subjects receiving Corplex P
干预措施: Corplex P is used to cover, protect, and provide a moist wound environment (Device)
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.
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)