New wound patch could speed healing of diabetic foot sores

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Must be at least 18 years of age and capable of providing informed consent. 2. Must have a full- or partial-thickness Wagner Grade 1 ulcer or wound on the foot; if involving the malleolus, no more than 50% of the wound may be above the midpoint of the medial malleolus. 3. Index wound/ulcer must be between 1 cm² and 20 cm² post-debridement. 4. Wound/ulcer must have been present for at least 4 weeks prior to screening. 5. Adequate circulation must be documented by one of the following: ABI between 0.7-1.2, TBI ≥ 0.7, TCPO2 ≥ 40 mmHg, or triphasic/biphasic Doppler waveforms. 6. Other wounds, if present, must be at least 2 cm from the index wound/ulcer. 7. Any previous infections must have been adequately treated per IDSA guidelines. 8. Subjects must agree to proper offloading and/or compression, have a stable living environment, and be able to attend follow-up visits. 9. Must provide written consent for digital imaging. 10. For Miro3D arm: Index wound/ulcer must have a clean base free of devitalized tissue or debris at the time of product placement. Exclusion Criteria: 1. Index wound/ulcer has reduced ≥30% after two weeks of SOC from screening to baseline. 2. Poorly controlled diabetes (HbA1c ≥ 12%). 3. Active, untreated or uncontrolled osteomyelitis. 4. Malignancy or vasculitis at the wound site. 5. Undergoing chemotherapy. 6. On dialysis. 7. Use of investigational drugs or therapies within 30 days prior to screening. 8. Conditions that would compromise study participation or adherence. 9. Known sensitivity to porcine materials. 10. Third-degree burns. 11. Worsening ischemia or gangrene at screening. 12. History of radiation to the wound site. 13. Exposed internal fixation, implants, or hardware in the wound. 14. Patient is transitioning to palliative or comfort care.