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

NCT07215741 | Active Not Recruiting

• 1 other identifier: REL2501.000-M (07/25)
• Study Type: observational
• Target: 50
• 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 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.

  1-12 weeks

Secondary Outcomes (3)

• Percent area reduction

  1-12 weeks

• Time to closure for the target ulcer

  1-12 weeks

• Adverse events

  1-12 weeks

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

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: December 1, 2025
• Last Updated: October 10, 2025

Record last verified: 2025-09

Locations

US (3)