Matrion™ Decellularized Placental Membrane in Subjects With Diabetic Foot Ulcers

NCT05087758 | Completed

• 1 other identifier: CR-21-001
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Diabetic Foot; Lower Extremity Wound

Keywords

diabetic foot ulcer; placental membrane; lower extremity wound; decellularized placental membrane

Outcome Measures

Primary Outcomes (1)

• Wound Healing

  Proportion of chronic DFUs that have achieved complete wound closure

  12 weeks

Secondary Outcomes (6)

• Speed of Wound Closure

  12 weeks

• Wound Area

  12 weeks

• Infection

  12 weeks

• Reoccurrence

  6 months post termination visit

• Grafts Used

  12 weeks

Study Arms (2)

Matrion decellularized placental membrane

EXPERIMENTAL

Matrion placental membrane graft will be use to treat subjects diagnosed with a diabetic foot ulcer.

Other: Matrion

Conventional Care Wound Management

ACTIVE COMPARATOR

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

Interventions

Matrion OTHER

Decellularized placental membrane applied to Wagner 1 and 2 diabetic foot ulcers

Matrion decellularized placental membrane

Conventional Care Wound Management OTHER

Advanced wound care with debridement and dressings

Conventional Care Wound Management

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LifeNet Health: lead

Study Sites (8)

Compass Medical Research Center, LLC

Tucson, Arizona, 85715, United States

Location

Center for Clinical Research, INC

Carmichael, California, 95608, United States

Location

Limb Preservation Platform, INC

Fresno, California, 93710, United States

Location

ILD Research Center

San Diego, California, 92130, United States

Location

Center for Clinical Research, INC

San Francisco, California, 94115, United States

Location

Doctors Research Network

Miami, Florida, 33143, United States

Location

Albuquerque Associated Podiatrists

Albuquerque, New Mexico, 87111, United States

Location

Purvis-Moyer Foot and Ankle Center

Rocky Mount, North Carolina, 27804, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 10, 2021
• First Posted: October 21, 2021
• Study Start: March 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: February 28, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)