Actively Recruiting
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
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 consent
- Diagnosed with Type I or Type II diabetes, on stable anti-diabetic treatment for at least 30 days before baseline
- Full-thickness wound below the ankle on the lower extremity
- Single target ulcer present
- Wound area greater than or equal to 1 cm2 and less than 25 cm2 with depth less than or equal to 9 mm
- Diabetic foot ulcer present for at least 30 days with Wagner Classification Grade 1 or 2
- No infection of the wound based on Infectious Disease Society of America criteria at screening and baseline
- Adequate circulation to the affected lower extremity as shown by specific oxygen, ankle-brachial index, or Doppler criteria within 60 days
- Ability to comply with off-loading and dressing change requirements
- Ability to understand study requirements and provide written informed consent
- Provided authorization for use and disclosure of protected health information
- Life expectancy greater than 6 months
You will not qualify if you...
- Pregnant or lactating
- Target wound less than 30 days old at screening with wound area decreased by 50% or more between screening and baseline
- Hemoglobin A1c greater than 12% within 90 days of screening
- Serum creatinine 3.0 mg/dL or greater within 30 days prior to screening
- Sensitivity to lincomycin, gentamicin, polymyxin B, or vancomycin
- Sensitivity to polysorbate 20, N-lauroyl sarcosinate, benzonase, or glycerol
- Wound treated with biomedical or topical growth factors within 30 days before screening
- Need for dressing materials not approved in the study
- Signs of infection at ulcer site at screening and baseline
- Unable to tolerate off-loading boot
- Known or suspected immune system disease
- Active or untreated cancer or uncontrolled connective tissue disease
- Treatment with immunosuppressive or chemotherapeutic agents, radiotherapy, or systemic corticosteroids less than 30 days before baseline
- Presence of necrosis, pus, or sinus tracts that cannot be removed by debridement at baseline
- Revascularization procedure less than 4 weeks before baseline
- Liver enzyme levels more than three times normal upper limit within 30 days prior to screening
- Active Charcot disease
- Treatment with living skin equivalent within 4 weeks before screening
- Evidence of peripheral vascular disease including more than one nonpalpable pulse on either foot
- Any condition judged by the investigator to pose undue risk or affect data quality
AI-Screening
AI-Powered Screening
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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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