Matrion™ Decellularized Placental Membrane in Subjects With Diabetic Foot Ulcers

Study Overview
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Brief Summary
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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.

Official Title
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An Open-Label Trial to Assess the Clinical Effectiveness of Matrion™ Decellularized Placental Membrane in Subjects With Diabetic Foot Ulcers

Conditions
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Diabetic Foot, Lower Extremity Wound

Intervention / Treatment
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* Other: Matrion
* Other: Conventional Care Wound Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study is a multicenter, randomized, controlled, open-label trial designed to evaluate the safety and efficacy of Matrion on the wound healing rate of diabetic foot ulcers.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Matrion decellularized placental membrane<br>Matrion placental membrane graft will be use to treat subjects diagnosed with a diabetic foot ulcer. | Other: Matrion<br>* Decellularized placental membrane applied to Wagner 1 and 2 diabetic foot ulcers<br>|
| Active Comparator: Conventional Care Wound Management<br>Currently accepted standard of care wound management including Conventional care dressings will be utilized in subjects with a diabetic foot ulcer diagnosis. | Other: Conventional Care Wound Management<br>* Advanced wound care with debridement and dressings<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Healing | Proportion of chronic DFUs that have achieved complete wound closure | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speed of Wound Closure | Time to wound closure measured from the baseline visit to the termination visit | 12 weeks | 
| Wound Area | Change in wound area over time | 12 weeks | 
| Infection | Rate of wound infection | 12 weeks | 
| Reoccurrence | Rate of reoccurrence of wound post treatment | 6 months post termination visit | 
| Grafts Used | Average number of Matrion grafts used per subject | 12 weeks | 
| Incidence of Treatment Emergent Adverse Events | Collection of adverse events, including changes in vital signs, ABI, and physical exams | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetic foot ulcer, placental membrane, lower extremity wound, decellularized placental membrane