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

NCT07215741 | Completed Results

• 1 other identifier: REL2501.000-M (07/25)
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Wounds; Diabetic Ulcers

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (2)

• Percent Area Reduction for Treated Ulcers Over 12 Weeks

  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

  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.

Study Arms (1)

Retrospective Relese

Retrospective case review to include all subjects that received Relese between May 2023 to April 2025.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive subjects receiving Relese in a real-world setting

You may qualify if:

• Consecutive diabetic subjects that received a Relese product application during treatment between May 2023 and April 2025.

You may not qualify if:

• Subjects not receiving an initial Relese application during treatment.

Sponsors & Collaborators

• StimLabs: lead

Study Sites (3)

Cypress Wound Care

Oklahoma City, Oklahoma, 73103, United States

Location

Premier Foot & Ankle

Denison, Texas, 75020, United States

Location

Premier Foot & Ankle

Frisco, Texas, 75033, United States

Location

Results Point of Contact

• Title: Melissa O'Connor
• Organization: StimLabs

melissa@stimlabs.com

888.346.9802

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 10, 2025
• Study Start: September 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: June 30, 2026
• Results First Posted: June 30, 2026

Record last verified: 2025-09

Locations

US (3)