Diabetic FootNCT05087758
Matrion™ Decellularized Placental Membrane in Subjects With Diabetic Foot Ulcers
A study testing Matrion and Conventional Care Wound Management in people with Diabetic Foot and Lower Extremity Wound, run by LifeNet Health at 8 sites in United States.
Trial summary
In this study, a novel placental membrane product Matrion™ (LifeNet Health, Inc., Virginia Beach, VA) will be used as a treatment for subjects with diabetic foot ulcers. Matrion is composed of placental membrane derived from donated human birth tissue containing both the innermost amniotic layer and the outermost… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Diabetic Foot, Lower Extremity Wound
- What is being tested?
- Matrion and Conventional Care Wound Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 8 sitesUnited States
- Study dates
- 1 Mar 2022to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be considered eligible to participate in the study, a subject must meet the inclusion criteria listed below:
- Be male or female, between 21 and 80 years of age at the time of consent
- For subjects with 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
- Have a full-thickness wound of the lower extremity
- Have a single target ulcer
- Have a wound with an area greater than or equal to 1 cm2 and less than 25 cm2 and a depth less than or equal to 9 mm
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- 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 including the full skin thickness but not underlying tissue
- Grade 2: ulcer extension involving ligament, tendon, joint capsule, or fascia, without presence of abscess of osteomyelitis
- Have an absence of infection based on Infectious Disease Society of America criteria
- Have an adequate circulation to the affected lower extremity, defined as at least one these criteria:
- Transcutaneous oxygen measurement at the dorsum of the foot greater or equal to 30 mmHg
- Ankle-brachial index (ABI) greater than 0.75
- At least biphasic Doppler arterial waveforms at the dorsalis pedis and posterior tibial arteries
- Have the ability to comply with off-loading (if required for specific wound) 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
- Have provided written authorization for use and disclosure of protected health information
- Have a life expectancy of greater than 6 months
Who cannot join
- To be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below:
- Be pregnant or lactating
- Have a wound that decreased in size ≥50% between the Screening and Baseline Visits
- Have circulating hemoglobin A1c exceeding 12% within 90 days of the Screening Visit
- Have serum creatinine concentrations of 3.0 mg/dL or greater within 30 days prior to screening
- Have a sensitivity to any of the following antibiotics: Lincomycin, Polymyxin B Sulfate, and/or Vancomycin
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- Have a sensitivity to N-Lauroyl Sarcosinate, and/or Benzonase® or Denarase®
- 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
- Have the inability to tolerate off-loading (a surgical shoe, removable cast walker or a total contact cast)
- 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
- Has undergone a revascularization procedure aimed at increasing blood flow in the treatment target limb less than 4 weeks before the baseline visit
- Have serum aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase levels greater than three times the normal upper limit within 30 days prior to screening
- Have evidence of active Charcot disease
- Have undergone treatment with a living skin equivalent within the last 4 weeks before screening
- Have ongoing evidence of peripheral vascular disease, including greater than one nonpalpable pulse on either foot
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Albuquerque Associated Podiatrists
Albuquerque, New Mexico, 87111
Center for Clinical Research, INC
Carmichael, California, 95608
Limb Preservation Platform, INC
Fresno, California, 93710
Doctors Research Network
Miami, Florida, 33143
Purvis-Moyer Foot and Ankle Center
Rocky Mount, North Carolina, 27804
ILD Research Center
San Diego, California, 92130
Center for Clinical Research, INC
San Francisco, California, 94115
Compass Medical Research Center, LLC
Tucson, Arizona, 85715
About this study
Official title: An Open-Label Trial to Assess the Clinical Effectiveness of Matrion™ Decellularized Placental Membrane in Subjects With Diabetic Foot Ulcers
In this study, a novel placental membrane product Matrion™ (LifeNet Health, Inc., Virginia Beach, VA) will be used as a treatment for subjects with diabetic foot ulcers. Matrion is composed of placental membrane derived from donated human birth tissue containing both the innermost amniotic layer and the outermost chorionic layer, inclusive of the trophoblast layer. Matrion is minimally processed and disinfected using a proprietary decellularization technology and terminally sterilized that safely renders the placental membrane acellular and sterile for its intended surgical applications.
- Conditions
- Diabetic Foot, Lower Extremity Wound
- Being tested
- Matrion, Conventional Care Wound Management
- Keywords
- diabetic foot ulcer, placental membrane, lower extremity wound, decellularized placental membrane
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MatrionOther
Decellularized placental membrane applied to Wagner 1 and 2 diabetic foot ulcers
Conventional Care Wound ManagementOther
Advanced wound care with debridement and dressings
| Study group | Role | What they receive |
|---|---|---|
| Matrion decellularized placental membrane | Experimental | Matrion placental membrane graft will be use to treat subjects diagnosed with a diabetic foot ulcer. Receives: Other: Matrion |
| Conventional Care Wound Management | Active comparator | Currently accepted standard of care wound management including Conventional care dressings will be utilized in subjects with a diabetic foot ulcer diagnosis. Receives: Other: Conventional Care Wound Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing
Proportion of chronic DFUs that have achieved complete wound closure
Measured: 12 weeks
Secondary outcomes (6)
Speed of Wound Closure
Time to wound closure measured from the baseline visit to the termination visit
Measured: 12 weeks
Wound Area
Change in wound area over time
Measured: 12 weeks
Infection
Rate of wound infection
Measured: 12 weeks
Reoccurrence
Rate of reoccurrence of wound post treatment
Measured: 6 months post termination visit
Grafts Used
Average number of Matrion grafts used per subject
Measured: 12 weeks
Incidence of Treatment Emergent Adverse Events
Collection of adverse events, including changes in vital signs, ABI, and physical exams
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start1 Mar 2022
- Primary completion31 Dec 2024
- Study completion28 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic FootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a multicenter, randomized, controlled, open-label trial designed to evaluate the safety and efficacy of Matrion on the wound healing rate of diabetic foot ulcers.
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeNet Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087758
- Sponsor's protocol ID
- CR-21-001
- Status last verified
- Mar 2025
- First submitted
- 10 Oct 2021
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Trial to Assess the Clinical Effectiveness of Matrion™ Decellularized Placental Membrane in Subjects With Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT05087758
- Acronym / sponsor ID
- CR-21-001
- Conditions
- Diabetic Foot, Lower Extremity Wound
- Keywords
- diabetic foot ulcer, placental membrane, lower extremity wound, decellularized placental membrane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- LifeNet HealthIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 28 Feb 2025 (actual)
- First posted
- 21 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, a novel placental membrane product Matrion™ (LifeNet Health, Inc., Virginia Beach, VA) will be used as a treatment for subjects with diabetic foot ulcers. Matrion is composed of placental membrane derived from donated human birth tissue containing both the innermost amniotic layer and the outermost chorionic layer, inclusive of the trophoblast layer. Matrion is minimally processed and disinfected using a proprietary decellularization technology and terminally sterilized that safely renders the placental membrane acellular and sterile for its intended surgical applications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study is a multicenter, randomized, controlled, open-label trial designed to evaluate the safety and efficacy of Matrion on the wound healing rate of diabetic foot ulcers.
| Arm | Type | Receives |
|---|---|---|
| Matrion decellularized placental membrane | Experimental | Other: MatrionMatrion placental membrane graft will be use to treat subjects diagnosed with a diabetic foot ulcer. |
| Conventional Care Wound Management | Active comparator | Other: Conventional Care Wound ManagementCurrently accepted standard of care wound management including Conventional care dressings will be utilized in subjects with a diabetic foot ulcer diagnosis. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- To be considered eligible to participate in the study, a subject must meet the inclusion criteria listed below:
- Be male or female, between 21 and 80 years of age at the time of consent
- For subjects with 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
- Have a full-thickness wound of the lower extremity
- Have a single target ulcer
Key exclusion criteria (21 listed)
- To be eligible for entry into the study, the subject must not meet any of the exclusion criteria listed below:
- Be pregnant or lactating
- Have a wound that decreased in size ≥50% between the Screening and Baseline Visits
- Have circulating hemoglobin A1c exceeding 12% within 90 days of the Screening Visit
- Have serum creatinine concentrations of 3.0 mg/dL or greater within 30 days prior to screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MatrionDecellularized placental membrane applied to Wagner 1 and 2 diabetic foot ulcers | Other | Matrion decellularized placental membrane |
| Conventional Care Wound ManagementAdvanced wound care with debridement and dressings | Other | Conventional Care Wound Management |
Primary outcome
Wound Healing
Time frame: 12 weeks
Proportion of chronic DFUs that have achieved complete wound closure
6 secondary outcomes
Speed of Wound Closure
Time frame: 12 weeks
Wound Area
Time frame: 12 weeks
Infection
Time frame: 12 weeks
Reoccurrence
Time frame: 6 months post termination visit
Grafts Used
Time frame: 12 weeks
Incidence of Treatment Emergent Adverse Events
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Diabetic Foot
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Matrion and Conventional Care Wound Management in people with Diabetic Foot and Lower Extremity Wound, run by LifeNet Health at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Healing (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.