Real-world Study of StimLabs Human Placental Membrane Tissue to Treat Hard-to-Heal Wounds

StimLabs23 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 Percentage of Treated Target Ulcers Achieving Complete Wound Closure During the Observational Period

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.

Time frame: 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.

Secondary Outcomes

Percent Area Reduction for Treated Ulcers Over 12 Weeks

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

Time frame: 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

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

Time frame: 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.

Data from ClinicalTrials.gov

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