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

3. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

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 studie

Intervenční

Zápis (Odhadovaný)

180

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Přístroj: 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.
Jiný: Standard of Care
Standard of care includes sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings.
Aktivní komparátor: 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.
Jiný: Standard of Care
Standard of care includes sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Proportion of Participants Achieving Complete Wound Closure of the Target Diabetic Foot Ulcer at 12 Weeks
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Mean Change From Baseline in Ulcer-Associated Pain Score Assessed by Numeric Pain Rating Scale (NPRS)
Časové okno: 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
Časové okno: 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

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change From Baseline in Tissue Oxygenation (StO₂) Values at Technology-Enabled Sites
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Reprise Biomedical, Inc.

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. června 2026

Primární dokončení (Odhadovaný)

1. března 2027

Dokončení studie (Odhadovaný)

1. května 2027

Termíny zápisu do studia

První předloženo

15. května 2026

První předloženo, které splnilo kritéria kontroly kvality

3. června 2026

První zveřejněno (Aktuální)

8. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

8. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

3. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • RB-FOCUS3D-DFU
  • IRB Tracking Number: 20261327 (Jiný identifikátor: WCG)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ano

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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