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

December 9, 2025 updated by: LifeNet Health

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Recruiting
        • Compass Medical Research Center
        • Principal Investigator:
          • Sarah Ducharme, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Wayne McLeod, FNP
    • California
      • Castro Valley, California, United States, 94546
        • Recruiting
        • Bay Area Foot Care
        • Principal Investigator:
          • Alexander Reyzelman, DPM
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Mher Vartivarian, DPM
        • Sub-Investigator:
          • Monara Dini, DPM
        • Sub-Investigator:
          • Charles Parks, DPM
      • Fresno, California, United States, 93710
        • Recruiting
        • Limb Preservaion Platform, Inc.
        • Principal Investigator:
          • Shawn Cazzell, DPM
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Theodore Torio, PA-C
      • San Francisco, California, United States, 94115
        • Recruiting
        • Center for Clinical Research, Inc
        • Principal Investigator:
          • Alexander Reyzelman, DPM
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Mher Vartivarian, DPM
        • Sub-Investigator:
          • Monara Dini, DPM
        • Sub-Investigator:
          • Charles Parks, DPM
      • San Francisco, California, United States, 94117
        • Recruiting
        • Bay Area Foot Care
        • Principal Investigator:
          • Alexander Reyzelman, DPM
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Mher Vartivarian, DPM
        • Sub-Investigator:
          • Monara Dini, DPM
        • Sub-Investigator:
          • Charles Parks, DPM
      • Vista, California, United States, 92081
        • Recruiting
        • ILD Research Center
        • Principal Investigator:
          • Dean Vayser, DPM
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Khen Rhem, DPM
    • Florida
      • Aventura, Florida, United States, 33180
      • Deerfield Beach, Florida, United States, 33442
        • Recruiting
        • South Florida Podiatry
        • Contact:
        • Principal Investigator:
          • Jay Seidel, MD
      • Hialeah, Florida, United States, 33015
        • Recruiting
        • Dinamo Research & Diagnostic Center, LLC
        • Principal Investigator:
          • Ramon Sastre, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Martin J Sueiro, MD
        • Sub-Investigator:
          • Luisisney Pedroso, APRN
      • Miami, Florida, United States, 33156
        • Recruiting
        • Doctors Research Network, Inc.
        • Principal Investigator:
          • Jason Hanft, DPM
        • Sub-Investigator:
          • Maria Surprenant, DPM
        • Contact:
        • Contact:
    • Illinois
      • Decatur, Illinois, United States, 62521
        • Recruiting
        • Independent Clinical Research
        • Contact:
        • Sub-Investigator:
          • Grant W Gonzalez, DPM
        • Contact:
        • Principal Investigator:
          • John M Sigle, DPM
        • Sub-Investigator:
          • Zachary K Janes, DPM
      • Springfield, Illinois, United States, 62704
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Recruiting
        • US Foot and Ankle Specialists
        • Contact:
        • Principal Investigator:
          • Alan Boehm, DPM
        • Sub-Investigator:
          • Kirk Woelffer, DPM
        • Sub-Investigator:
          • Jordan Meyers, DPM
        • Sub-Investigator:
          • Patrick Dougherty, DPM
        • Sub-Investigator:
          • Douglas Smith, DPM
      • Rocky Mount, North Carolina, United States, 27804
        • Recruiting
        • Foot and Ankle Institute of the Carolinas
        • Principal Investigator:
          • Peter Moyer, DPM
        • Contact:
    • Texas
    • Virginia
      • Salem, Virginia, United States, 24175
        • Recruiting
        • Foot and Ankle Specialists of the Mid-Atlantic
        • Principal Investigator:
          • Nathan Young, DPM
        • Sub-Investigator:
          • Ivan Rubiano, DPM
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Charles Zelen, DPM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

To be considered eligible to participate in this study, a subject must meet the inclusion criteria listed below:

  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:

    • 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

Exclusion Criteria:

To be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below:

  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
  11. Have a known or suspected disease of the immune system
  12. Have an active or untreated malignancy or active, uncontrolled connective tissue disease
  13. Had a treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before the Baseline Visit
  14. Have presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement (assessed at Baseline/Visit 2)
  15. Has undergone a revascularization procedure aimed at increasing blood flow in the treatment target limb less than 4 weeks before the Baseline Visit
  16. Have serum aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase levels greater than three times the normal upper limit within 30 days prior to screening (assessed at Screening/Visit 1 if subject had labs collected <30 days of screening; assessed at Baseline/Visit 2 if subject had labs collected at screening)
  17. Have active Charcot disease
  18. Have undergone treatment with a living skin equivalent within the last 4 weeks before screening
  19. Have ongoing evidence of peripheral vascular disease, including greater than one nonpalpable pulse on either foot
  20. Have the presence of any condition that in the opinion of the investigator places the subject at undue risk or potentially jeopardizes the quality of the data to be generated

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Arm 1:
Matrion
Other: Graft Application
Place the graft on the debrided DFU and secure. Follow with conventional care wound management (dressings and off-loading). Product may be applied weekly.
Other Names:
  • Matrion
Other: Arm 2
Conventional Wound Management
Other: Wound Dressing Material
The wound will be debrided and undergo a moist-wound therapy and will be covered with a gauze that is appropriate for the type of wound (moist or dry). Dressings will cover each wound wound for at least 5 days, but no more than 9 days, (7 days +/- 2 days) until the next study visit. Off-loading of the wound is required.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound Healing
Time Frame: 12 Weeks
Proportion of diabetic foot ulcers that have achieved complete wound closure
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speed of Wound Closure
Time Frame: 12 weeks
Time to wound closure measured from the baseline visit to the termination visit
12 weeks
Infection
Time Frame: 12 weeks
Rate of wound infection
12 weeks
Grafts Used
Time Frame: 12 weeks
Average number of Matrion grafts used per subject
12 weeks
Incidence of Treatment Emergent Adverse Events
Time Frame: 12 weeks
Collection of adverse events, including changes in vital signs, ABI, and physical exams
12 weeks
Assessment of Wound Closure Rates in Study Participants
Time Frame: 12 weeks
Number of subjects with a healed wound
12 weeks
Reoccurrence
Time Frame: 14 weeks
Rate of re-occurrence of wound during follow-up period
14 weeks
Change in Wound Area
Time Frame: 12 weeks
Change in wound area over time
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LifeNet Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

August 7, 2025

First Submitted That Met QC Criteria

August 7, 2025

First Posted (Actual)

August 12, 2025

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-24-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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