RECRUITING

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

Conditions

Diabetic Foot Ulcer (DFU)Lower Extremity diabetic foot ulcer placental membrane lower extremity wound decellularized placental membrane foot diseases foot ulcer conventional wound management

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Open-Label Trial to Assess the Clinical Effectiveness of Matrion Decellularized Placental Membrane Versus Conventional Wound Management in Subjects With Diabetic Foot Ulcers

Quick Facts

Study Start:2025-06-26

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07116876

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Be male or female and aged between 21 and 80 years at the time of consent 2. Have 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. 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 and 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 notunderlying 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	1. Be pregnant or lactating 2. Subjects with a target wound \<30 days old at Screening whose wound 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

Inclusion Criteria

Exclusion Criteria

1. Be male or female and aged between 21 and 80 years at the time of consent
2. Have 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.
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 and 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 notunderlying 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

1. Be pregnant or lactating
2. Subjects with a target wound \<30 days old at Screening whose wound 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

Contacts and Locations

Study Locations (Sites)

Compass Medical Research Center

Tucson, Arizona, 85715

United States

Limb Preservaion Platform, Inc.

Fresno, California, 93710

United States

Center for Clinical Research, Inc

San Francisco, California, 94115

United States

ILD Research Center

Vista, California, 92081

United States

Doctors Research Network, Inc.

Miami, Florida, 33156

United States

Independent Clinical Research, LLC

Springfield, Illinois, 62704

United States

Element Research Group

San Antonio, Texas, 78258

United States

Collaborators and Investigators

Sponsor: LifeNet Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-26

Study Completion Date2026-06

Study Record Updates

Study Start Date2025-06-26

Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Diabetic Foot Ulcer (DFU)
Lower Extremity