Actively Recruiting
An Open-Label Trial to Assess the Clinical Effectiveness of Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers
Led by LifeNet Health · Updated on 2025-12-10
120
Participants Needed
18
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating Matrion™, a placental membrane product derived from donated human birth tissue, as a treatment for diabetic foot ulcers (DFU). This study compares Matrion to conventional wound care, focusing on healing outcomes for ulcers in adults aged 21 to 80 years with type I or type II diabetes. Matrion is processed to be acellular and sterile, making it suitable for surgical use in treating wounds. Participants will be randomly assigned to receive either Matrion graft application or conventional wound management. The Matrion graft is applied to the cleaned ulcer and secured, potentially repeated weekly, along with standard dressings and off-loading. The conventional care group will receive moist wound therapy with appropriate gauze dressings changed every 5 to 9 days and off-loading support. Both groups will be monitored over a 12-week period to assess wound healing. During the study, participants will attend regular visits for wound assessment including size, depth, and healing progress. Researchers will track wound closure rates, infection, recurrence, and any adverse events related to treatments. The main outcome is wound healing at 12 weeks, with follow-up evaluations including speed of closure and graft use. Participants must comply with dressing changes and off-loading requirements and will be monitored for safety throughout the trial, which is expected to end by June 2026.
CONDITIONS
Brief Title
Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 21 to 80 years at the time of consent
- Diagnosis of type I or type II diabetes with stable anti-diabetic treatment for at least 30 days
- Full-thickness wound below the ankle on the lower extremity
- Single target ulcer present
- Wound area between 1 cm² and less than 25 cm² with depth up to 9 mm
- Diabetic foot ulcer present for at least 30 days with Wagner Grade 1 or 2
- No infection based on Infectious Disease Society of America criteria at screening and baseline
- Adequate circulation to affected limb by specified measurements within previous 60 days
- Ability to comply with off-loading and dressing change requirements
- Ability to understand and consent to study requirements
- Provided written authorization for use of protected health information
- Life expectancy greater than 6 months
You will not qualify if you...
- Pregnant or lactating
- Wound less than 30 days old with size reduced by 50% or more between screening and baseline
- Hemoglobin A1c over 12% within 90 days before screening
- Serum creatinine 3.0 mg/dL or greater within 30 days prior to screening
- Sensitivity to specific antibiotics or study product components
- Wound treated with biomedical or topical growth factors within 30 days prior to screening
- Need for additional dressing materials not approved in the study
- Signs of infection at ulcer site at screening or baseline
- Unable to tolerate off-loading boot
- Known or suspected immune system disease
- Active or untreated cancer or connective tissue disease
- Treatment with immunosuppressive, chemotherapeutic agents, radiotherapy, or systemic corticosteroids within 30 days before baseline
- Presence of necrosis, purulence, or sinus tracts not removable by debridement
- Revascularization procedure less than 4 weeks before baseline
- Elevated liver enzymes greater than three times normal within 30 days prior to screening
- Active Charcot disease
- Treatment with living skin equivalent within 4 weeks before screening
- Evidence of peripheral vascular disease with multiple nonpalpable pulses
- Any condition placing subject at undue risk or jeopardizing study data quality
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive either the Matrion decellularized placental membrane graft applied weekly on the debrided diabetic foot ulcer or conventional wound management with moist-wound therapy and appropriate dressings changed every 5 to 9 days. Off-loading of the wound is required throughout the treatment.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 18 locations
1
Compass Medical Research Center
Tucson, Arizona, United States, 85715
Actively Recruiting
2
Bay Area Foot Care
Castro Valley, California, United States, 94546
Actively Recruiting
3
Limb Preservaion Platform, Inc.
Fresno, California, United States, 93710
Actively Recruiting
4
Center for Clinical Research, Inc
San Francisco, California, United States, 94115
Actively Recruiting
5
Bay Area Foot Care
San Francisco, California, United States, 94117
Actively Recruiting
6
ILD Research Center
Vista, California, United States, 92081
Actively Recruiting
7
Humanity Clinical Research, Corp
Aventura, Florida, United States, 33180
Actively Recruiting
8
South Florida Podiatry
Deerfield Beach, Florida, United States, 33442
Actively Recruiting
9
Dinamo Research & Diagnostic Center, LLC
Hialeah, Florida, United States, 33015
Actively Recruiting
10
Doctors Research Network, Inc.
Miami, Florida, United States, 33156
Actively Recruiting
11
Independent Clinical Research
Decatur, Illinois, United States, 62521
Actively Recruiting
12
Independent Clinical Research, LLC
Springfield, Illinois, United States, 62704
Actively Recruiting
13
US Foot and Ankle Specialists
Raleigh, North Carolina, United States, 27609
Actively Recruiting
14
Foot and Ankle Institute of the Carolinas
Rocky Mount, North Carolina, United States, 27804
Actively Recruiting
15
Olympus Clinical Research
Katy, Texas, United States, 77450
Actively Recruiting
16
Element Research Group
San Antonio, Texas, United States, 78258
Actively Recruiting
17
Olympus-Alcanza
Sugar Land, Texas, United States, 77479
Actively Recruiting
18
Foot and Ankle Specialists of the Mid-Atlantic
Salem, Virginia, United States, 24175
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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