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Completed

NCT Number: NCT07215741

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

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.

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Key information

Conditions

Chronic Wounds Diabetic Ulcers

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cypress Wound Care, Oklahoma City, Oklahoma, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The Percentage of Treated Target Ulcers Achieving Complete Wound Closure During the Observational Period

    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.

    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.

Secondary outcomes

  1. Percent Area Reduction for Treated Ulcers Over 12 Weeks

    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.

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

  2. Time to Closure for the Treated Target Ulcers

    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 (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.

Sponsors and collaborators

Lead sponsor

StimLabs

Industry

Registry information

Official study title

A Retrospective, Multi-center Real-world Study of StimLabs Human Placental Membrane Tissue Used for Treatment in Hard-to-Heal Wounds

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 10, 2025
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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