NCT06544564

Human Amniotic Membrane On Venous Leg Ulcers In an Elderly Population

A Multi-Center, Prospective, Randomized Trial Evaluating the Efficacy of Membrane Wrap, A Human Amniotic Membrane on Venous Leg Ulcers in an Elderly Population

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: BioLab Holdings · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to assess the clinical effectiveness of Membrane Wrap, a human amniotic membrane for the management of difficult to heal partial- or full-thickness venous leg ulcers (VLUs)

Detailed description

Multi-center (up to 20 sites), prospective, randomized trial assess the clinical effectiveness of human amniotic membrane(s) for the management of difficult to heal partial- or full-thickness venous leg ulcers (VLUs). The primary objective is to evaluate the effectiveness of Membrane wrap™ versus Standard of Care (SOC) in subject with eligible venous leg ulcers.

Conditions

• Venous Leg Ulcer

Interventions

Type	Name	Description
DEVICE	Membrane Wrap™	Membrane Wrap™
OTHER	Standard of Care	SOC treatment will be defined as: 1) debridement of non-viable, necrotic tissue, 2) application of Biologic as the primary, wound covering, 3) application of a dressing over Biologic that maintains moisture balance, 4) application of a Class 3 high compression system, and 5) wrapping with a covering dressing

Timeline

• Start date: 2025-03-31
• Primary completion: 2025-09-30
• Completion: 2026-09-30
• First posted: 2024-08-09
• Last updated: 2025-07-03

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study