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

NCT07116876 | Recruiting

• 1 other identifier: CR-24-002
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

Diabetic Foot Ulcer (DFU); Lower Extremity

Keywords

diabetic foot ulcer; placental membrane; lower extremity wound; decellularized placental membrane; foot diseases; foot ulcer; conventional wound management

Outcome Measures

Primary Outcomes (1)

• Wound Healing

  Proportion of diabetic foot ulcers that have achieved complete wound closure

  12 Weeks

Secondary Outcomes (7)

• Speed of Wound Closure

  12 weeks

• Change in Wound Area

  12 weeks

• Assessment of Wound Closure Rates in Study Participants

  12 weeks

• Infection

  12 weeks

• Reoccurrence

  14 weeks

Study Arms (2)

Arm 1:

OTHER

Matrion

Other: Graft Application

Arm 2

OTHER

Conventional Wound Management

Other: Wound Dressing Material

Interventions

Wound Dressing Material OTHER

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.

Arm 2

Graft Application OTHER

Place the graft on the debrided DFU and secure. Follow with conventional care wound management (dressings and off-loading). Product may be applied weekly.

Also known as: Matrion

Arm 1:

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 and aged between 21 and 80 years at the time of informed consent
• 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.
• Have full-thickness wound of the lower extremity, below the ankle
• Have a single target ulcer
• 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
• 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
• Have an absence of infection based on Infectious Disease Society of America criteria (assessed at BOTH Screening/Visit 1 and Baseline/Visit 2)
• 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
• Have the ability to comply with off-loading 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
• 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)
• 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)
• 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)
• Have a sensitivity to either of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin
• Have a sensitivity to polysorbate 20, N-lauroyl sarcosinate, benzonase or glycerol
• 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 (assessed at BOTH Screening/Visit 1 and Baseline/Visit 2)
• Have the inability to tolerate an off-loading boot
• 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 (assessed at Baseline/Visit 2)
• 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 (18)

Compass Medical Research Center

Tucson, Arizona, 85715, United States

RECRUITING

Bay Area Foot Care

Castro Valley, California, 94546, United States

RECRUITING

Limb Preservaion Platform, Inc.

Fresno, California, 93710, United States

RECRUITING

Center for Clinical Research, Inc

San Francisco, California, 94115, United States

RECRUITING

Bay Area Foot Care

San Francisco, California, 94117, United States

RECRUITING

ILD Research Center

Vista, California, 92081, United States

RECRUITING

Humanity Clinical Research, Corp

Aventura, Florida, 33180, United States

RECRUITING

South Florida Podiatry

Deerfield Beach, Florida, 33442, United States

RECRUITING

Dinamo Research & Diagnostic Center, LLC

Hialeah, Florida, 33015, United States

RECRUITING

Doctors Research Network, Inc.

Miami, Florida, 33156, United States

RECRUITING

Independent Clinical Research

Decatur, Illinois, 62521, United States

RECRUITING

Independent Clinical Research, LLC

Springfield, Illinois, 62704, United States

RECRUITING

US Foot and Ankle Specialists

Raleigh, North Carolina, 27609, United States

RECRUITING

Foot and Ankle Institute of the Carolinas

Rocky Mount, North Carolina, 27804, United States

RECRUITING

Olympus Clinical Research

Katy, Texas, 77450, United States

RECRUITING

Element Research Group

San Antonio, Texas, 78258, United States

RECRUITING

Olympus-Alcanza

Sugar Land, Texas, 77479, United States

RECRUITING

Foot and Ankle Specialists of the Mid-Atlantic

Salem, Virginia, 24175, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Foot Diseases; Foot Ulcer

Interventions

Bandages

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Equipment and Supplies

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 post market, multicenter, randomized, open-label trial designed to evaluate the treatment response of Matrion compared to Conventional Wound Management on the wound healing rate of diabetic foot ulcers. Subjects from each clinical site will be evaluated using protocol-specific eligibility criteria to determine who qualifies for study participation.

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 12, 2025
• Study Start: June 26, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)