Miro3D Wound Matrix for Treatment of Diabetic Foot Ulcers
Eligible age
18+ yrs
Accepts
All genders
Locations
8 states
Healthy volunteers
No
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About this study
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.
Sponsor: Reprise Biomedical, Inc.
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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.
Where it's recruiting
Source: ClinicalTrials.gov · NCT07632001 · last updated 2026-06-08