Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers
NCT ID: NCT07116876
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2025-06-26
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1:
Matrion
Graft Application
Place the graft on the debrided DFU and secure. Follow with conventional care wound management (dressings and off-loading). Product may be applied weekly.
Arm 2
Conventional Wound Management
Wound Dressing Material
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.
Interventions
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Graft Application
Place the graft on the debrided DFU and secure. Follow with conventional care wound management (dressings and off-loading). Product may be applied weekly.
Wound Dressing Material
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Have full-thickness wound of the lower extremity, below the ankle
4. Have a single target ulcer
5. 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
6. 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
7. Have an absence of infection based on Infectious Disease Society of America criteria (assessed at BOTH Screening/Visit 1 and Baseline/Visit 2)
8. 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
9. Have the ability to comply with off-loading and dressing change requirements
10. 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
11. Have provided written authorization for use and disclosure of protected health information
12. Have a life expectancy of greater than 6 months
Exclusion Criteria
2. 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)
3. 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)
4. 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)
5. Have a sensitivity to either of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin
6. Have a sensitivity to polysorbate 20, N-lauroyl sarcosinate, benzonase or glycerol
7. Have the wound treated with biomedical or topical growth factors within the previous 30 days before the Screening Visit
8. Need for any additional concomitant dressing material other than the ones approved for this study
9. Have clinical signs of an infection at the study ulcer site (assessed at BOTH Screening/Visit 1 and Baseline/Visit 2)
10. Have the inability to tolerate an off-loading boot
11. Have a known or suspected disease of the immune system
12. Have an active or untreated malignancy or active, uncontrolled connective tissue disease
13. Had a treatment with immunosuppressive or chemotherapeutic agents, radiotherapy or systemic corticosteroids less than 30 days before the Baseline Visit
14. Have presence of necrosis, purulence, or sinus tracts that cannot be removed by debridement (assessed at Baseline/Visit 2)
15. Has undergone a revascularization procedure aimed at increasing blood flow in the treatment target limb less than 4 weeks before the Baseline Visit
16. Have serum aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase levels greater than three times the normal upper limit within 30 days prior to screening (assessed at Screening/Visit 1 if subject had labs collected \<30 days of screening; assessed at Baseline/Visit 2 if subject had labs collected at screening)
17. Have active Charcot disease
18. Have undergone treatment with a living skin equivalent within the last 4 weeks before screening
19. Have ongoing evidence of peripheral vascular disease, including greater than one nonpalpable pulse on either foot
20. 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
21 Years
80 Years
ALL
No
Sponsors
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LifeNet Health
INDUSTRY
Responsible Party
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Locations
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Compass Medical Research Center
Tucson, Arizona, United States
Bay Area Foot Care
Castro Valley, California, United States
Limb Preservaion Platform, Inc.
Fresno, California, United States
Center for Clinical Research, Inc
San Francisco, California, United States
Bay Area Foot Care
San Francisco, California, United States
ILD Research Center
Vista, California, United States
Humanity Clinical Research, Corp
Aventura, Florida, United States
South Florida Podiatry
Deerfield Beach, Florida, United States
Dinamo Research & Diagnostic Center, LLC
Hialeah, Florida, United States
Doctors Research Network, Inc.
Miami, Florida, United States
Independent Clinical Research
Decatur, Illinois, United States
Independent Clinical Research, LLC
Springfield, Illinois, United States
US Foot and Ankle Specialists
Raleigh, North Carolina, United States
Foot and Ankle Institute of the Carolinas
Rocky Mount, North Carolina, United States
Olympus Clinical Research
Katy, Texas, United States
Element Research Group
San Antonio, Texas, United States
Olympus-Alcanza
Sugar Land, Texas, United States
Foot and Ankle Specialists of the Mid-Atlantic
Salem, Virginia, United States
Countries
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Facility Contacts
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Other Identifiers
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CR-24-002
Identifier Type: -
Identifier Source: org_study_id
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