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

NCT ID: NCT07215741

Last Updated: 2025-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Wounds Diabetic Ulcers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Retrospective Relese

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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StimLabs

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cypress Wound Care

Oklahoma City, Oklahoma, United States

Site Status

Premier Foot & Ankle

Denison, Texas, United States

Site Status

Premier Foot & Ankle

Frisco, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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REL2501.000-M (07/25)

Identifier Type: -

Identifier Source: org_study_id

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