NCT05087758

Matrion™ Decellularized Placental Membrane in Subjects With Diabetic Foot Ulcers

An Open-Label Trial to Assess the Clinical Effectiveness of Matrion™ Decellularized Placental Membrane in Subjects With Diabetic Foot Ulcers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: LifeNet Health · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In this study, a novel placental membrane product Matrion™ (LifeNet Health, Inc., Virginia Beach, VA) will be used as a treatment for subjects with diabetic foot ulcers. Matrion is composed of placental membrane derived from donated human birth tissue containing both the innermost amniotic layer and the outermost chorionic layer, inclusive of the trophoblast layer. Matrion is minimally processed and disinfected using a proprietary decellularization technology and terminally sterilized that safely renders the placental membrane acellular and sterile for its intended surgical applications.

Conditions

• Diabetic Foot
• Lower Extremity Wound

Interventions

Type	Name	Description
OTHER	Matrion	Decellularized placental membrane applied to Wagner 1 and 2 diabetic foot ulcers
OTHER	Conventional Care Wound Management	Advanced wound care with debridement and dressings

Timeline

• Start date: 2022-03-01
• Primary completion: 2024-12-31
• Completion: 2025-02-28
• First posted: 2021-10-21
• Last updated: 2025-04-02

Locations

8 sites across 1 country: United States