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

BioLab Holdings

Status: Active, not recruiting

Conditions: Pressure Ulcer (PU); Venous Leg Ulcer (VLU); Diabetic Foot Ulcer (DFU)

Treatments: Device: Membrane Wrap™; Device: Tri-Membrane Wrap™; Other: Standard of Care; Device: Membrane Wrap-Hydro™

Study type: Observational

Funder types: Industry

Identifiers

NCT07078968

RWE-001-25

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 500 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

500 participants in 2 patient groups

Group 1 Amniotic Membrane

Description:

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

Treatment:

Device: Membrane Wrap-Hydro™

Device: Tri-Membrane Wrap™

Device: Membrane Wrap™

Group 2 SOC

Description:

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.

Treatment:

Other: Standard of Care