NCT07078968

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: BioLab Holdings · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Tri-Membrane Wrap™	Membrane Wrap™
DEVICE	Membrane Wrap™	Membrane Wrap™
DEVICE	Membrane Wrap-Hydro™	Membrane Wrap-Hydro™
OTHER	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.

Timeline

• Start date: 2025-04-23
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2025-07-22
• Last updated: 2025-07-22

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study