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Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers

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

NCT07116876•LifeNet Health

View on ClinicalTrials.gov

Summary

This study will evaluate Matrion™ (LifeNet Health, Inc., Virginia Beach, VA), a placental membrane product, as a treatment for diabetic foot ulcers compared to conventional wound care. Matrion is derived from donated human birth tissue and includes both the amniotic and chorionic layers, along with the trophoblast layer. It is minimally processed using a proprietary decellularization method and terminally sterilized to ensure the membrane is acellular and sterile, making it suitable for surgical applications.

Eligibility

Age

21 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Be male or female and aged between 21 and 80 years at the time of informed consent
•2. Have a diagnosis of Type I or Type II diabetes as defined by the American Diabetes Association and have been on a stable anti-diabetic treatment regimen for at least 30 days before the baseline visit.
•3. Have full-thickness wound of the lower extremity, below the ankle
•4. Have a single target ulcer
•5. Have a wound with an area greater than or equal to 1cm2 and less than 25 cm2 with a depth less than or equal to 9 mm
•6. Have a diabetic foot ulcer that has been present for at least 30 days with a Wagner Classification Grade 1 or 2:
•* Grade 1: superficial diabetic ulcer involving the full skin thickness but not underlying tissues
•* Grade 2: ulcer extension involving ligament, tendon, joint capsule, or fascia, without presence of abscess or osteomyelitis
•7. Have an absence of infection based on Infectious Disease Society of America criteria (assessed at BOTH Screening/Visit 1 and Baseline/Visit 2)
•8. Have an adequate circulation to the affected lower extremity, defined as at least one of the criteria within the previous 60 days:
+7 more criteria

Exclusion Criteria

•1. Be pregnant or lactating
•2. Subjects with a target wound \<30 days old at Screening whose wound area has decreased in size ≥50% between the Screening and Baseline Visits (assessed at Baseline/Visit 2)
•3. Have a circulating hemoglobin A1c exceeding 12% within 90 days of the Screening Visit (assessed at Screening/Visit 1 for subjects with labs collected \<30 days of screening; assessed at Baseline/Visit 2 for subjects with labs collected at screening)
•4. Have a serum creatinine concentration of 3.0 mg/dL or greater within 30 days prior to screening (assessed at Screening/Visit 1 for subjects with labs collected \<30 days of screening; assessed at Baseline/Visit 2 for subjects with labs collected at screening)
•5. Have a sensitivity to either of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin
•6. Have a sensitivity to polysorbate 20, N-lauroyl sarcosinate, benzonase or glycerol
•7. Have the wound treated with biomedical or topical growth factors within the previous 30 days before the Screening Visit
•8. Need for any additional concomitant dressing material other than the ones approved for this study
•9. Have clinical signs of an infection at the study ulcer site (assessed at BOTH Screening/Visit 1 and Baseline/Visit 2)
•10. Have the inability to tolerate an off-loading boot
+10 more criteria

Locations (18)

Compass Medical Research Center

Tucson, Arizona, United States

Bay Area Foot Care

Castro Valley, California, United States

Limb Preservaion Platform, Inc.

Fresno, California, United States

Center for Clinical Research, Inc

San Francisco, California, United States

Bay Area Foot Care

San Francisco, California, United States

ILD Research Center

Vista, California, United States

Humanity Clinical Research, Corp

Aventura, Florida, United States

South Florida Podiatry

Deerfield Beach, Florida, United States

Dinamo Research & Diagnostic Center, LLC

Hialeah, Florida, United States

Doctors Research Network, Inc.

Miami, Florida, United States

Key Dates

Start Date

June 26, 2025

Primary Completion Date

May 1, 2026

Completion Date

June 1, 2026

Last Updated

December 10, 2025

Enrollment

120

ESTIMATED participants

Conditions

Diabetic Foot Ulcer (DFU)Lower Extremity

Interventions

Graft Application

OTHER

Wound Dressing Material

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers

Inclusion Criteria

Exclusion Criteria

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