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Matrion for Diabetic Foot Ulcers

This study is testing a product called Matrion, made from donated human birth tissue, to see if it helps heal diabetic foot ulcers (DFUs) better than standard wound care. Matrion is a special membrane that has been processed to be sterile and free of cells. Researchers will compare Matrion application to traditional wound dressings. You may be able to join if you are between 21 and 80 years old, have type 1 or type 2 diabetes, and have been on a stable diabetes treatment for at least 30 days. The main goal is to see how well wounds heal after 12 weeks. The study plans to enroll 120 people, but its current status is unclear.

Study design
This interventional study plans to enroll 120 participants to compare Matrion graft application with conventional wound management. It is not specified if the study is randomized or blinded.
What's involved
If you receive Matrion, it will be applied weekly to your wound. If you receive conventional care, your wound will be debrided and covered with a dressing for 5 to 9 days until your next visit.
Compensation
Not stated in the trial record.
Follow-up
Wound healing will be measured at 12 weeks.

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NCT07116876

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

Recruiting
NAAges 21–80InterventionalTreatment
LifeNet Health
~120 participants
Updated 2025-12-10 on ClinicalTrials.gov
What's tested:Graft ApplicationWound Dressing Material

At a glance

Recruiting sites
18 of 18 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Wound Healing
Measured over 12 Weeks

Conditions

Diabetic Foot Ulcer (DFU)
Lower Extremity

Explore related trials

Diabetic foot ulcer

Where it's being run

18 sites across 7 states
California5
Florida4
Texas3
Illinois2
North Carolina2
Arizona1
Virginia1

Who to contact

Heather Kimbriel
[email protected]
520-526-2325
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
Transcutaneous oxygen measurement at the dorsum of the foot greater or equal to 30 mm Hg
Ankle-brachial index (ABI) ranging from 0.8 to 1.2
At least biphasic Doppler arterial waveforms at the dorsalis pedis and posterior tibial arteries 9. Have the ability to comply with off-loading and dressing change requirements 10. Have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an institutional review board (IRB), and agree to abide by the study restrictions and return to the site for the required assessments 11. Have provided written authorization for use and disclosure of protected health information 12. Have a life expectancy of greater than 6 months

What this trial measures

  • Wound Healing12 Weeks

    Proportion of diabetic foot ulcers that have achieved complete wound closure