Miro3D Wound Matrix for Treatment of Diabetic Foot Ulcers

NCT07632001 | Recruiting FDA Device

• 2 other identifiers: RB-FOCUS3D-DFUIRB Tracking Number: 20261327
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 14

Brief Summary

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.

Conditions

Diabetic Foot Ulcers (DFUs); Diabetic Foot; Chronic Wounds

Keywords

Miro3D; Wound Matrix; Extracellular Matrix; Acellular Dermal Matrix; Diabetic Foot Ulcer; Chronic Wound Healing; Advanced Wound Care; Randomized Controlled Trial; Wound Closure; Tissue Regeneration; Offloading; Debridement

Outcome Measures

Primary Outcomes (2)

• Proportion of Participants Achieving Complete Wound Closure of the Target Diabetic Foot Ulcer at 12 Weeks

  Complete wound closure is defined as full re-epithelialization of the target ulcer without drainage or need for dressing, with closure confirmed at a single healing confirmation visit conducted approximately two weeks after complete closure is initially documented.

  Up to 12 weeks

• Mean Percentage Reduction in Target Ulcer Surface Area From Baseline to 12 Weeks

  Percentage area reduction (PAR) is defined as the percent change in surface area of the target ulcer from baseline, as measured by digital planimetry.

  Baseline through 12 weeks

Secondary Outcomes (2)

• Mean Change From Baseline in Ulcer-Associated Pain Score Assessed by Numeric Pain Rating Scale (NPRS)

  Baseline through 12 weeks

• Number of Participants Experiencing Treatment-Emergent Adverse Events

  Up to 12 weeks

Other Outcomes (2)

• Change From Baseline in Tissue Oxygenation (StO₂) Values at Technology-Enabled Sites

  Baseline through 12 weeks

• Change From Baseline in Fluorescence Imaging Signal Values at Technology-Enabled Sites

  Baseline through Week 12

Study Arms (2)

Miro3D Wound Matrix Plus Standard of Care

EXPERIMENTAL

Participants will receive Miro3D Wound Matrix in addition to standard of care, including sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings.

Device: Miro3D Wound Matrix; Other: Standard of Care

Standard of Care Alone

ACTIVE COMPARATOR

Participants will receive standard of care alone, including sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings.

Other: Standard of Care

Interventions

Miro3D Wound Matrix DEVICE

Miro3D Wound Matrix is a sterile, acellular, three-dimensional scaffold derived from porcine liver tissue and applied topically to the wound following appropriate wound bed preparation to support tissue regeneration and healing.

Miro3D Wound Matrix Plus Standard of Care

Standard of Care OTHER

Standard of care includes sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings.

Miro3D Wound Matrix Plus Standard of Care; Standard of Care Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Reprise Biomedical, Inc.: lead

Study Sites (14)

Advanced Foot Care

Phoenix, Arizona, 85032, United States

RECRUITING

West Boca Center for Wound Healing

Coconut Creek, Florida, 33073, United States

NOT YET RECRUITING

Solutions Medical Research

Coral Gables, Florida, 33134, United States

RECRUITING

Doctors Research Network

Miami, Florida, 33156, United States

NOT YET RECRUITING

Barry University

Tamarac, Florida, 33321, United States

RECRUITING

Clinical Trials of New England

Hyde Park, Massachusetts, 02136, United States

NOT YET RECRUITING

Mercy Hyperbaric and Wound Care

St Louis, Missouri, 63128, United States

NOT YET RECRUITING

St. Louis Foot & Ankle

St Louis, Missouri, 63128, United States

NOT YET RECRUITING

Christian Hospital Wound Center

St Louis, Missouri, 63136, United States

NOT YET RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

NOT YET RECRUITING

ABC Podiatry

Columbus, Ohio, 43213, United States

RECRUITING

Dynamic Wound Care

Oklahoma City, Oklahoma, 73159, United States

NOT YET RECRUITING

Caring Foot and Ankle Specialists

Houston, Texas, 77035, United States

RECRUITING

Vital Heart and Vein

Humble, Texas, 77338, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Foot

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Erin Badali

CONTACT

763-284-6785; ebadali@reprisebio.com

Greg Smock

CONTACT

763-284-6780; gsmock@reprisebio.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: (Not required since fully open-label)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio to receive either Miro3D Wound Matrix in addition to standard of care or standard of care alone, with both groups followed concurrently for evaluation of wound healing outcomes over a 12-week treatment period.

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: June 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

US (14)