Active — Not RecruitingNot Applicable

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

United States500 participantsStarted 2025-04-23

Plain-language summary

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.

Who can participate

SexALL

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Inclusion criteria

✓. Subject had the presence of diabetic foot ulcers, Venous insufficiency ulcers, pressure ulcers and/or post-operative wounds
✓. 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.
✓. Subjects should have been treated from January 2022 to present day.

Exclusion criteria

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

What they're measuring

Frequency of wound closure by or on week 16

Timeframe: 16 weeks

Trial details

NCT IDNCT07078968

SponsorBioLab Holdings

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-10

View on ClinicalTrials.gov More Venous Leg Ulcer (VLU) trials