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Matrion™ Decellularized Placental Membrane in Subjects With Diabetic Foot Ulcers

NCT05087758 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2025-04-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • LifeNet Health

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2024-12-31
Completion
2025-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05087758 on ClinicalTrials.gov