Matrion™ Decellularized Placental Membrane in Subjects With Diabetic Foot Ulcers

Completed · Not applicable

Conditions studied: Diabetic Foot, Lower Extremity Wound

In brief

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.

Key facts

Study ID: NCT05087758
Run by: LifeNet Health
People needed: 108
Starts: 2022-03-01
Expected to finish: 2025-02-28
Last updated by the study team: 2025-04-02

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

To be considered eligible to participate in the study, a subject must meet the inclusion criteria listed below:
Be male or female, between 21 and 80 years of age at the time of consent
For subjects with a diagnosis of Type I or Type II diabetes as defined by the American Diabetes Association, have been on a stable anti-diabetic treatment for at least 30 days before the baseline visit
Have a full-thickness wound of the lower extremity
Have a single target ulcer
Have a wound with an area greater than or equal to 1 cm2 and less than 25 cm2 and a depth less than or equal to 9 mm
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 including the full skin thickness but not underlying tissue
Grade 2: ulcer extension involving ligament, tendon, joint capsule, or fascia, without presence of abscess of osteomyelitis
Have an absence of infection based on Infectious Disease Society of America criteria
Have an adequate circulation to the affected lower extremity, defined as at least one these criteria:
Transcutaneous oxygen measurement at the dorsum of the foot greater or equal to 30 mmHg
Ankle-brachial index (ABI) greater than 0.75
At least biphasic Doppler arterial waveforms at the dorsalis pedis and posterior tibial arteries
Have the ability to comply with off-loading (if required for specific wound) and dressing change requirements
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
Have provided written authorization for use and disclosure of protected health information
Have a life expectancy of greater than 6 months

You may not qualify if…

To be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below:
Be pregnant or lactating
Have a wound that decreased in size ≥50% between the Screening and Baseline Visits
Have circulating hemoglobin A1c exceeding 12% within 90 days of the Screening Visit
Have serum creatinine concentrations of 3.0 mg/dL or greater within 30 days prior to screening
Have a sensitivity to any of the following antibiotics: Lincomycin, Polymyxin B Sulfate, and/or Vancomycin
Have a sensitivity to N-Lauroyl Sarcosinate, and/or Benzonase® or Denarase®
Have the wound treated with biomedical or topical growth factors within the previous 30 days before the screening visit
Need for any additional concomitant dressing material other than the ones approved for this study
Have clinical signs of an infection at the study ulcer site
Have the inability to tolerate off-loading (a surgical shoe, removable cast walker or a total contact cast)
Have a known or suspected disease of the immune system
Have an active or untreated malignancy or active, uncontrolled connective tissue disease
Had a treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before the baseline visit
Have presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement
Has undergone a revascularization procedure aimed at increasing blood flow in the treatment target limb less than 4 weeks before the baseline visit
Have serum aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase levels greater than three times the normal upper limit within 30 days prior to screening
Have evidence of active Charcot disease
Have undergone treatment with a living skin equivalent within the last 4 weeks before screening
Have ongoing evidence of peripheral vascular disease, including greater than one nonpalpable pulse on either foot
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

Where it is running

Compass Medical Research Center, LLC — Tucson, Arizona, United States
Center for Clinical Research, INC — Carmichael, California, United States
Limb Preservation Platform, INC — Fresno, California, United States
ILD Research Center — San Diego, California, United States
Center for Clinical Research, INC — San Francisco, California, United States
Doctors Research Network — Miami, Florida, United States
Albuquerque Associated Podiatrists — Albuquerque, New Mexico, United States
Purvis-Moyer Foot and Ankle Center — Rocky Mount, North Carolina, United States

Full record on ClinicalTrials.gov

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