AzTrials
AzTrials

Diabetic Foot Ulcer (DFU)NCT07116876

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

A study testing Graft Application and Wound Dressing Material in people with Diabetic Foot Ulcer (DFU) and Lower Extremity, run by LifeNet Health at 17 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 21 to 80 years
Conditions the study is for
Diabetic Foot Ulcer (DFU), Lower Extremity
What is being tested?
Graft Application and Wound Dressing Material
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
17 sitesUnited States
Study dates
26 Jun 2025to 30 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 this study, a subject must meet the inclusion criteria listed below:
  • Be male or female and aged between 21 and 80 years at the time of informed consent
  • 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.
  • Have full-thickness wound of the lower extremity, below the ankle
  • Have a single target ulcer
  • 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
Show all 18Show fewer
  • 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
  • Have an absence of infection based on Infectious Disease Society of America criteria (assessed at BOTH Screening/Visit 1 and Baseline/Visit 2)
  • 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
  • Have the ability to comply with off-loading 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
  • 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)
  • 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)
  • 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)
  • Have a sensitivity to either of the following antibiotics: lincomycin, gentamicin, polymyxin B, or vancomycin
Show all 21Show fewer
  • Have a sensitivity to polysorbate 20, N-lauroyl sarcosinate, benzonase or glycerol
  • 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 (assessed at BOTH Screening/Visit 1 and Baseline/Visit 2)
  • Have the inability to tolerate an off-loading boot
  • 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 (assessed at Baseline/Visit 2)
  • 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 (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)
  • Have 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

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Humanity Clinical Research, Corp

    Aventura, Florida, 33180

  • Bay Area Foot Care

    Castro Valley, California, 94546

  • Independent Clinical Research

    Decatur, Illinois, 62521

  • Limb Preservaion Platform, Inc.

    Fresno, California, 93710

  • Dinamo Research & Diagnostic Center, LLC

    Hialeah, Florida, 33015

  • Olympus Clinical Research

    Katy, Texas, 77450

  • Doctors Research Network, Inc.

    Miami, Florida, 33156

  • US Foot and Ankle Specialists

    Raleigh, North Carolina, 27609

  • Foot and Ankle Institute of the Carolinas

    Rocky Mount, North Carolina, 27804

  • Foot and Ankle Specialists of the Mid-Atlantic

    Salem, Virginia, 24175

  • Element Research Group

    San Antonio, Texas, 78258

  • Center for Clinical Research, Inc

    San Francisco, California, 94115

  • Bay Area Foot Care

    San Francisco, California, 94117

  • Independent Clinical Research, LLC

    Springfield, Illinois, 62704

  • Olympus-Alcanza

    Sugar Land, Texas, 77479

  • Compass Medical Research Center

    Tucson, Arizona, 85715

  • ILD Research Center

    Vista, California, 92081

Other trials in United States

About this study

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

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.

Being tested
Graft Application, Wound Dressing Material
Keywords
diabetic foot ulcer, placental membrane, lower extremity wound, decellularized placental membrane, foot diseases, foot ulcer, conventional wound management
Medical subject headings
Diabetic Foot, Foot Diseases, Foot Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Graft ApplicationOther

    Also called Matrion

    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 MaterialOther

    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.

Study groups in NCT07116876
Study groupRoleWhat they receive
Arm 1:OtherMatrion
Receives: Other: Graft Application
Arm 2OtherConventional Wound Management
Receives: Other: Wound Dressing Material

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Wound Healing

    Proportion of diabetic foot ulcers that have achieved complete wound closure

    Measured: 12 Weeks

Secondary outcomes (7)

  1. Speed of Wound Closure

    Time to wound closure measured from the baseline visit to the termination visit

    Measured: 12 weeks

  2. Change in Wound Area

    Change in wound area over time

    Measured: 12 weeks

  3. Assessment of Wound Closure Rates in Study Participants

    Number of subjects with a healed wound

    Measured: 12 weeks

  4. Infection

    Rate of wound infection

    Measured: 12 weeks

  5. Reoccurrence

    Rate of re-occurrence of wound during follow-up period

    Measured: 14 weeks

  6. Grafts Used

    Average number of Matrion grafts used per subject

    Measured: 12 weeks

  7. 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.

  1. First posted12 Aug 2025
  2. Study start26 Jun 2025
  3. Primary completion15 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

Resources

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 post market, multicenter, randomized, open-label trial designed to evaluate the treatment response of Matrion compared to Conventional Wound Management on the wound healing rate of diabetic foot ulcers. Subjects from each clinical site will be evaluated using protocol-specific eligibility criteria to determine who qualifies for study participation.
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07116876
Sponsor's protocol ID
CR-24-002
Status last verified
Sep 2026
First submitted
7 Aug 2025
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Graft Application and Wound Dressing Material in people with Diabetic Foot Ulcer (DFU) and Lower Extremity, run by LifeNet Health at 17 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: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 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?

This study is still under way. Results are not available in the source record yet.

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?

On the ClinicalTrials.gov record for NCT07116876.

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 14 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in