Miro3D Wound Matrix for Treatment of Diabetic Foot Ulcers

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.