Retrospective, Multi-center Real-world Study of StimLabs Human Placental Membrane Tissue to Treat Hard-to-Heal Wounds
- Conditions
- Chronic WoundsDiabetic Ulcers
- Registration Number
- NCT07215741
- Lead Sponsor
- StimLabs
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Consecutive diabetic subjects that received a Relese product application during treatment between May 2023 and April 2025.
- Subjects not receiving an initial Relese application during treatment.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of target ulcers achieving complete wound closure during the observational period 1-12 weeks Determine the percent (%) of target ulcers achieving complete wound closure at 12 weeks.
- Secondary Outcome Measures
Name Time Method Percent area reduction 1-12 weeks Percent Area Reduction (PAR) will be calculated from Treatment Visit 1 to Treatment Visit 12.
Time to closure for the target ulcer 1-12 weeks Time to closure (days) will be determined from the first product application to the date when the wound is first documented as fully closed.
Adverse events 1-12 weeks Incidence of adverse events will be evaluated weekly.
Trial Locations
- Locations (2)
Cypress Wound Care
🇺🇸Oklahoma City, Oklahoma, United States
Premier Foot & Ankle
🇺🇸Frisco, Texas, United States
Cypress Wound Care🇺🇸Oklahoma City, Oklahoma, United States