Miro3D Wound Matrix for Treatment of Diabetic Foot Ulcers

Recruiting now · Not applicable

Conditions studied: Diabetic Foot Ulcers (DFUs), Diabetic Foot, Chronic Wounds

In brief

This study is designed to evaluate whether the Miro3D Wound Matrix, when used in addition to standard of care, improves healing outcomes in patients with chronic diabetic foot ulcers. Diabetic foot ulcers are a common and serious complication of diabetes and may be difficult to heal despite appropriate treatment. Standard of care typically includes regular wound cleaning, debridement (removal of dead tissue), offloading (reducing pressure on the wound), and moisture-balancing dressings. However, some wounds fail to heal with standard treatment alone. Miro3D Wound Matrix is a three-dimensional, acellular scaffold derived from porcine tissue that is intended to support wound healing. This study will compare outcomes in patients treated with Miro3D plus standard of care versus standard of care alone. Approximately 180 adult subjects with non-healing diabetic foot ulcers will be enrolled at multiple clinical sites in the United States. After a two-week screening period, eligible participants will be randomly assigned to receive either Miro3D in addition to standard of care or standard of care alone. Subjects will be followed for up to 12 weeks with weekly clinic visits. The primary objective of the study is to determine whether treatment with Miro3D increases the rate of complete wound closure and improves reduction in wound size compared to standard of care alone. Safety will also be evaluated by monitoring adverse events throughout the study.

Key facts

Study ID: NCT07632001
Run by: Reprise Biomedical, Inc.
People needed: 180
Starts: 2026-06-01
Expected to finish: 2027-05-01
Last updated by the study team: 2026-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subjects 18 years of age or older.
Subject history of Type I or Type II Diabetes Mellitus requiring treatment with oral medications and/or insulin replacement therapy.
A diabetic foot ulcer present for greater than 4 weeks (documented in the medical record) but less than 12 months duration if being treated with active SOC.
Objectively, less than 25% wound area reduction in the two-week screening period prior to randomization.
Study ulcer is a minimum of 1.0cm2 and a maximum of 25 cm2 post-debridement at first treatment visit.
Index ulcer and/or index ulcer limb may have had prior infection, but infection(s) must be adequately treated and controlled as defined by IDSA Guidelines Grade level 1.
The subject is able and willing to follow the protocol requirements.
Subject has signed informed consent.
Subjects with the following ulcer:
A. Presence of a diabetic foot ulcer Wagner 1 or 2 grade at the first screening visit on any aspect of the foot, provided 50% of the wound sits below the level of the malleolus. This includes DFUs as a result of open amputation sites and surgical wound dehiscence as long as all other criteria are met. [NOTE: If two or more DFUs are present with the same grade, the index ulcer is the largest ulcer and the only one evaluated in the study. Index ulcer must be more than 2 cm distant apart.]
Adequate circulation to the affected foot as demonstrated by a dorsum transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg; Toe pressures >50mmHg; an ABI between 0.7 and ≤ 1.3, or TBI of >0.6 within 3 months of the first Screening Visit.
Negative pregnancy test for females of childbearing potential (e.g., not post- menopausal for at least one year or surgically sterile). Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence) starting at Screening and continuing through the duration of their study participation.
The index ulcer has been offloaded with protocol defined offloading device throughout the study run-in period for at least 14 days prior to randomization (Run- in period defined as Screening through TV1/Randomization).
The index ulcer has a clean base and is free of necrotic debris at time of placement of treatment product.

You may not qualify if…

Subject has a known life expectancy of < 1 year.
Index ulcer has been present for >1 year.
Patient does not have adequate 2-week historical data demonstrating < 25% area reduction.
Subject is unable to comply with offloading device.
Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence to medical treatment.
Subject has ulcers that are completely necrotic or fibrotic tissue.
Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
Subject currently being treated for an active malignant disease or subjects with history of malignancy within the ulcer.
The Subject has other concurrent conditions that in the opinion of the Principal Investigator may compromise subject safety.
Known contraindications to acellular dermal matrices or known allergies to any of the Miro3D components.
Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
Index ulcer has reduced in area by ≥25% after 2 weeks of standard of care from the first screening visit (S1) to the TV1/randomization visit.
Subject is pregnant or breastfeeding.
Subjects with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids >10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 30 days prior to randomization visit or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
Index ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, Matristem) including any other CAMP within the last 30 days preceding the first treatment visit.
Affected extremity requiring hyperbaric oxygen during the trial or within 2 weeks of screening visit 1.
Presence of diabetes with poor metabolic control as documented with an HbA1c ≥12.0 within 30 days of randomization (TV1).
Index ulcer and/or index limb with presence of gangrene or unstable ischemia at screening (SV1).
Revascularization surgery on the lower extremity on which the index ulcer is located within 30 days of Screening Visit (SV1).
Index ulcer in the opinion of the Principal Investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a neoplasm of the ulcer.
Any clinically significant finding, in the judgment of the Principal Investigator, that would place the subject at health risk, impact the study, or affect the completion of the study.

Where it is running

Advanced Foot Care — Phoenix, Arizona, United States (enrolling)
Solutions Medical Research — Coral Gables, Florida, United States (enrolling)
Barry University — Tamarac, Florida, United States (enrolling)
ABC Podiatry — Columbus, Ohio, United States (enrolling)
Caring Foot and Ankle Specialists — Houston, Texas, United States (enrolling)
Vital Heart and Vein — Humble, Texas, United States (enrolling)
Mercy Hyperbaric and Wound Care — St Louis, Missouri, United States
St. Louis Foot & Ankle — St Louis, Missouri, United States
Christian Hospital Wound Center — St Louis, Missouri, United States
West Boca Center for Wound Healing — Coconut Creek, Florida, United States
Icahn School of Medicine at Mount Sinai — New York, New York, United States
Doctors Research Network — Miami, Florida, United States
Dynamic Wound Care — Oklahoma City, Oklahoma, United States
Clinical Trials of New England — Hyde Park, Massachusetts, United States

Full record on ClinicalTrials.gov

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