A Randomized Controlled Multicenter Trial, Examining the Effect of Miro3D Wound Matrix on the Rate of Complete Wound Closure of Chronic Diabetic Foot Ulcers
Reprise Biomedical, Inc.
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.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceMiro3D 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.
- OtherStandard of Care
Standard of care includes sharp debridement, offloading using a protocol-defined device, and appropriate moisture-retentive dressings.
Locations (14)
- Advanced Foot CarePhoenix, Arizona
- West Boca Center for Wound HealingCoconut Creek, Florida
- Solutions Medical ResearchCoral Gables, Florida
- Doctors Research NetworkMiami, Florida
- Barry UniversityTamarac, Florida
- Clinical Trials of New EnglandHyde Park, Massachusetts