NCT07364630

A Multicenter, Prospective, Controlled Modified Multi-Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers.

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: BioLab Holdings · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a multicenter, prospective, controlled modified multi-platform trial assessing the efficacy of human placental membrane products and standard of care in the management of nonhealing diabetic foot ulcers and venous leg ulcers.

Detailed description

This study follows a rescue design: patients in the SOC arm who fail to heal during the BIOCAMP Prospective Modified Dual Platform Multicenter Randomized Controlled Clinical Trial will enter the Rescue trial and receive one of the study products. Patients enrolled in this trial must still meet medical necessity criteria for cellular, acellular, matrix-like, products (CAMPs) recently published by the Medicare Administrative Contractor's (MAC) in their local coverage determinations (LCD).

Conditions

• Diabetic Foot Ulcer
• Foot Ulcer Chronic
• DFU
• Ulcer Foot
• Venous Leg Ulcer (VLU)
• Venous Leg Ulcer
• Venous Ulcer
• Leg Ulcers
• Ulcer

Interventions

Type	Name	Description
OTHER	Tri-Membrane Wrap™ DFU	Participants will receive weekly applications of Tri-Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHER	Membrane Wrap™ DFU	Participants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHER	Membrane Wrap-Lite™ DFU	Participants will receive weekly applications of Membrane Wrap-Lite™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHER	Membrane Wrap-Hydro™ DFU	Participants will receive weekly applications of Membrane Wrap-Hydro™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHER	Tri-Membrane Wrap™ VLU	Participants will receive weekly applications of Tri-Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHER	Membrane Wrap™ VLU	Participants will receive weekly applications of Membrane Wrap™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHER	Membrane Wrap-Lite™ VLU	Participants will receive weekly applications of Membrane Wrap-Lite™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.
OTHER	Membrane Wrap-Hydro™ VLU	Participants will receive weekly applications of Membrane Wrap-Hydro™ and Standard of Care until ulcer closure, or a maximum of 12 weeks, whichever occurs first.

Timeline

• Start date: 2026-01-02
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2026-01-23
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States