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Miro3D Wound Matrix for Treatment of Diabetic Foot Ulcers (FOCUS 3D)

3 czerwca 2026 zaktualizowane przez: Reprise Biomedical, Inc.

A Randomized Controlled Multicenter Trial, Examining the Effect of Miro3D Wound Matrix on the Rate of Complete Wound Closure of Chronic Diabetic Foot Ulcers

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

This is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate the safety and effectiveness of the Miro3D Wound Matrix in the treatment of chronic, non-healing diabetic foot ulcers (DFUs).

Diabetic foot ulcers represent a significant clinical and economic burden and are associated with increased risk of infection, hospitalization, and amputation. Despite adherence to standard of care (SOC), including offloading, debridement, infection control, and moisture management, a substantial proportion of DFUs fail to achieve complete healing. This study aims to assess whether adjunctive treatment with Miro3D Wound Matrix can improve healing outcomes compared to SOC alone.

Miro3D Wound Matrix is a sterile, acellular, three-dimensional scaffold derived from porcine liver tissue. The matrix is designed to provide a structural environment that supports tissue regeneration and wound healing. The product is applied topically to the wound following appropriate wound bed preparation.

Approximately 180 adult subjects with Wagner Grade 1 or 2 diabetic foot ulcers will be enrolled across up to 20 clinical sites in the United States. Subjects must have ulcers present for at least 4 weeks but less than 12 months and must demonstrate less than 25% reduction in wound area during a two-week screening period under standard of care.

Following screening, eligible subjects will be randomized in a 1:1 ratio to one of two treatment arms: treatment with Miro3D Wound Matrix in addition to standard of care, or standard of care alone.

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

Subjects will be evaluated at weekly intervals for up to 12 weeks. At each visit, assessments will include wound measurement, photographic documentation, infection status, pain assessment using the Numeric Pain Rating Scale (NPRS), and monitoring of adverse events. At select sites, additional exploratory imaging assessments may be performed, including near-infrared tissue oxygenation and fluorescence imaging.

The primary endpoints of the study are complete wound closure at 12 weeks, defined as full re-epithelialization without drainage or need for dressing, with closure confirmed at a single healing confirmation visit conducted two weeks after complete closure is initially documented, and percentage area reduction of the target ulcer over the study period. Secondary endpoints include change in pain associated with the ulcer and the incidence and frequency of adverse events. Exploratory endpoints will assess spatial and temporal changes in tissue oxygenation and fluorescence imaging characteristics at technology-enabled sites.

The study will use a Bayesian adaptive statistical framework, incorporating prior information and observed data to estimate treatment effects. Interim analyses may be conducted to evaluate efficacy, safety, and sample size assumptions.

This study is intended to generate clinical evidence supporting the use of Miro3D Wound Matrix as an adjunctive therapy for improving healing outcomes in patients with chronic diabetic foot ulcers.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

180

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Stany Zjednoczone
    • Arizona
      • Phoenix, Arizona, Stany Zjednoczone, 85032
        • Rekrutacyjny
        • Advanced Foot Care
        • Główny śledczy:
          • Jaminelli Banks
        • Kontakt:
    • Florida
      • Coconut Creek, Florida, Stany Zjednoczone, 33073
        • Jeszcze nie rekrutacja
        • West Boca Center for Wound Healing
        • Kontakt:
        • Główny śledczy:
          • Eric Lullove
      • Coral Gables, Florida, Stany Zjednoczone, 33134
      • Miami, Florida, Stany Zjednoczone, 33156
        • Jeszcze nie rekrutacja
        • Doctors Research Network
        • Kontakt:
        • Główny śledczy:
          • Maria Surprenant
      • Tamarac, Florida, Stany Zjednoczone, 33321
        • Rekrutacyjny
        • Barry University
        • Kontakt:
        • Główny śledczy:
          • Cherison Cuffy
    • Massachusetts
      • Hyde Park, Massachusetts, Stany Zjednoczone, 02136
        • Jeszcze nie rekrutacja
        • Clinical Trials of New England
        • Kontakt:
        • Główny śledczy:
          • Michael Lowney
    • Missouri
      • St Louis, Missouri, Stany Zjednoczone, 63128
        • Jeszcze nie rekrutacja
        • Mercy Hyperbaric and Wound Care
        • Kontakt:
        • Główny śledczy:
          • Amy Couch
      • St Louis, Missouri, Stany Zjednoczone, 63128
        • Jeszcze nie rekrutacja
        • St. Louis Foot & Ankle
        • Kontakt:
        • Główny śledczy:
          • Raymond Abdo
      • St Louis, Missouri, Stany Zjednoczone, 63136
        • Jeszcze nie rekrutacja
        • Christian Hospital Wound Center
        • Kontakt:
        • Główny śledczy:
          • Bradley Freeman
    • New York
      • New York, New York, Stany Zjednoczone, 10029
        • Jeszcze nie rekrutacja
        • Icahn School of Medicine at Mount Sinai
        • Główny śledczy:
          • John Lantis
        • Kontakt:
    • Ohio
      • Columbus, Ohio, Stany Zjednoczone, 43213
        • Rekrutacyjny
        • ABC Podiatry
        • Główny śledczy:
          • Richard Schilling
        • Kontakt:
    • Oklahoma
      • Oklahoma City, Oklahoma, Stany Zjednoczone, 73159
    • Texas
      • Houston, Texas, Stany Zjednoczone, 77035
      • Humble, Texas, Stany Zjednoczone, 77338

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria

  1. Subjects 18 years of age or older.
  2. Subject history of Type I or Type II Diabetes Mellitus requiring treatment with oral medications and/or insulin replacement therapy.
  3. 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.
  4. Objectively, less than 25% wound area reduction in the two-week screening period prior to randomization.
  5. Study ulcer is a minimum of 1.0cm2 and a maximum of 25 cm2 post-debridement at first treatment visit.
  6. 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.
  7. The subject is able and willing to follow the protocol requirements.

  8. 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.]

  9. 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.
  10. 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.
  11. 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).
  12. The index ulcer has a clean base and is free of necrotic debris at time of placement of treatment product.

Exclusion Criteria

  1. Subject has a known life expectancy of < 1 year.
  2. Index ulcer has been present for >1 year.
  3. Patient does not have adequate 2-week historical data demonstrating < 25% area reduction.
  4. Subject is unable to comply with offloading device.
  5. 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.
  6. Subject has ulcers that are completely necrotic or fibrotic tissue.
  7. Subject has major uncontrolled medical disorders such as serious cardiovascular, renal, liver or pulmonary disease, lupus, palliative care or sickle cell anemia.
  8. Subject currently being treated for an active malignant disease or subjects with history of malignancy within the ulcer.
  9. The Subject has other concurrent conditions that in the opinion of the Principal Investigator may compromise subject safety.
  10. Known contraindications to acellular dermal matrices or known allergies to any of the Miro3D components.
  11. Concurrent participation in another clinical trial that involves an investigational drug or device that would interfere with this study.
  12. 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.
  13. Subject is pregnant or breastfeeding.
  14. 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.
  15. 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.
  16. Affected extremity requiring hyperbaric oxygen during the trial or within 2 weeks of screening visit 1.
  17. Presence of diabetes with poor metabolic control as documented with an HbA1c ≥12.0 within 30 days of randomization (TV1).
  18. Index ulcer and/or index limb with presence of gangrene or unstable ischemia at screening (SV1).
  19. Revascularization surgery on the lower extremity on which the index ulcer is located within 30 days of Screening Visit (SV1).
  20. 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.
  21. 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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Miro3D Wound Matrix Plus Standard of Care
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.
Urządzenie: Miro3D Wound Matrix
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.
Inny: Standard of Care
Standard of care includes sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings.
Aktywny komparator: Standard of Care Alone
Participants will receive standard of care alone, including sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings.
Inny: Standard of Care
Standard of care includes sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Proportion of Participants Achieving Complete Wound Closure of the Target Diabetic Foot Ulcer at 12 Weeks
Ramy czasowe: Up to 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
Ramy czasowe: Baseline through 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Mean Change From Baseline in Ulcer-Associated Pain Score Assessed by Numeric Pain Rating Scale (NPRS)
Ramy czasowe: Baseline through 12 weeks
Ulcer-associated pain will be assessed using the Numeric Pain Rating Scale (NPRS), a patient-reported scale ranging from 0 (no pain) to 10 (worst possible pain).
Baseline through 12 weeks
Number of Participants Experiencing Treatment-Emergent Adverse Events
Ramy czasowe: Up to 12 weeks
Treatment-emergent adverse events will be collected and coded throughout the study period and summarized by treatment group.
Up to 12 weeks

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Change From Baseline in Tissue Oxygenation (StO₂) Values at Technology-Enabled Sites
Ramy czasowe: Baseline through 12 weeks
Exploratory assessment of change from baseline in tissue oxygenation (StO₂) values measured using imaging technology at technology-enabled study sites. Outcome data will include longitudinal changes in measured StO₂ values collected during the study period.
Baseline through 12 weeks
Change From Baseline in Fluorescence Imaging Signal Values at Technology-Enabled Sites
Ramy czasowe: Baseline through Week 12
Exploratory assessment of change from baseline in fluorescence imaging signal values measured using imaging technology at technology-enabled study sites. Outcome data will include longitudinal changes in measured fluorescence imaging signal values collected during the study period.
Baseline through Week 12

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Reprise Biomedical, Inc.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 marca 2027

Ukończenie studiów (Szacowany)

1 maja 2027

Daty rejestracji na studia

Pierwszy przesłany

15 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

8 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

8 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • RB-FOCUS3D-DFU
  • IRB Tracking Number: 20261327 (Inny identyfikator: WCG)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Opis planu IPD

At this time, the sponsor has not made a final determination regarding the sharing of individual participant data. Any future decision to share de-identified data will be made in accordance with applicable regulatory requirements, data privacy considerations, and sponsor policies, and may depend on the nature of future scientific collaborations and publication plans.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Tak

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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