Retrospective, Multi-center Real-world Study of StimLabs Human Placental Membrane Tissue to Treat Hard-to-Heal Wounds

N/AActive Not RecruitingNCT07215741

StimLabs50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Wounds Diabetic Ulcers

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Consecutive diabetic subjects that received a Relese product application during treatment between May 2023 and April 2025. Exclusion Criteria: * Subjects not receiving an initial Relese application during treatment.

Locations (3)

Cypress Wound Care

Oklahoma City, Oklahoma, United States

Premier Foot & Ankle

Denison, Texas, United States

Premier Foot & Ankle

Frisco, Texas, United States

Outcomes

Primary Outcomes

The proportion of target ulcers achieving complete wound closure during the observational period

Determine the percent (%) of target ulcers achieving complete wound closure at 12 weeks.

Time frame: 1-12 weeks

Secondary Outcomes

Percent area reduction

Percent Area Reduction (PAR) will be calculated from Treatment Visit 1 to Treatment Visit 12.

Time frame: 1-12 weeks

Time to closure for the target ulcer

Time to closure (days) will be determined from the first product application to the date when the wound is first documented as fully closed.

Time frame: 1-12 weeks

Adverse events

Incidence of adverse events will be evaluated weekly.

Time frame: 1-12 weeks

Data from ClinicalTrials.gov

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