A REAL WORLD DATA COLLECTION OF HUMAN AMNIOTIC MEMBRANE(S) ON DIABETIC FOOT ULCERS, VENOUS LEG ULCERS, PRESSURE ULCERS AND POST OPERATIVE WOUNDS

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

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-23

Study Completion Date

2025-10-31

Brief Summary

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This study is designed to evaluate the effectiveness of Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ compared to the effectiveness of Standard of Care alone though a retrospective data collection.

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Detailed Description

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This is a retrospective multi-center study collecting real world evidence on the use of Tri-Membrane Wrap™, Membrane Wrap™, Membrane Wrap-Hydro™ and Standard of Care alone in subjects with eligible DFUs, VLUs, PUs, and post operative wounds that have not healed with conventional therapy for greater than or equal to 4 weeks.

Conditions

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Venous Leg Ulcer (VLU) Diabetic Foot Ulcer (DFU) Pressure Ulcer (PU)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1 Amniotic Membrane

De-Identified subject data will be extracted from investigators' medical records for subjects who received Tri-Membrane Wrap™, Membrane Wrap™, Membrane Wrap-Hydro™ plus SOC in subjects with eligible DFUs, VLUs, PUs and post operative wounds

Tri-Membrane Wrap™

Intervention Type DEVICE

Membrane Wrap™

Intervention Type DEVICE

Membrane Wrap™

Membrane Wrap-Hydro™

Intervention Type DEVICE

Membrane Wrap-Hydro™

Group 2 SOC

De-identified subject data will be extracted from investigators' medical records who were treated with only Standard of Care with eligible DFUs, VLUs, PUs and post operative wounds. Subjects in the SOC may have received hyperbaric or wound vac therapies as part of their treatments.

Standard of Care

Intervention Type OTHER

Basic care involves debridement, along with local wound care depending on the wound needs. Debridement involves removal of fibrin and devitalized tissue from the base and the borders of the ulcer which is necessary in all treatment plans to reduce the risk of infection and promote healing.

Interventions

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Tri-Membrane Wrap™

Membrane Wrap™

Intervention Type DEVICE

Membrane Wrap™

Intervention Type DEVICE

Membrane Wrap-Hydro™

Intervention Type DEVICE

Standard of Care

Basic care involves debridement, along with local wound care depending on the wound needs. Debridement involves removal of fibrin and devitalized tissue from the base and the borders of the ulcer which is necessary in all treatment plans to reduce the risk of infection and promote healing.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Subject had the presence of diabetic foot ulcers, Venous insufficiency ulcers, pressure ulcers and/or post-operative wounds
2. Subject has retrospectively been treated with Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ or Subject has retrospectively been treated with Standard of Care only.
3. Subjects should have been treated from January 2022 to present day.

Exclusion Criteria

1. Subjects that did not have a wound closure verification appointment.
2. Any subject who received any product other than Tri-Membrane Wrap™, Membrane Wrap™ and Membrane Wrap-Hydro™ during their treatment time.

Eligible Sex

ALL

Accepts Healthy Volunteers

No