NCT06939673 Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 20 participants in total. It began in 2024-02-29 with a primary completion date of 2025-12-31.

Brief Summary

This clinical study is being conducted to evaluate how well the Miro3D Wound Matrix helps heal difficult wounds and ulcerations in an outpatient care setting. Miro3D is a biologic wound dressing made from porcine (pig) liver tissue. It is processed to remove all cells, creating a clean scaffold that can support the body's natural healing process. The goal of this study is to see how effective Miro3D is when used alongside standard wound care for helping wounds close and reducing pain and discomfort. The study is designed as a post-market, proof-of-concept trial, meaning the product is already commercially available, and researchers are evaluating how it works in real-world clinical settings. A total of up to 20 adult participants will be enrolled. Participants may have wounds such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, or surgical wound dehiscence. These wounds may be complex in nature, including tunneling or undermining, which often makes them more difficult to treat. Participants will receive standard wound care along with weekly Miro3D applications for the first 4 weeks. If the wound is not fully healed after 4 weeks, Miro3D will then be applied every 2 weeks until healing is achieved or up to 12 weeks total. Throughout the study, participants will return weekly for wound assessments and to complete brief questionnaires about their pain levels and quality of life. The main goals of the study are: 1. To measure how much the wound size shrinks (known as percent area reduction or PAR). 2. To evaluate how much healthy granulation tissue (new tissue) forms in the wound. 3. To compare healing outcomes when Miro3D is used weekly versus every two weeks. 4. To understand how the treatment affects patients' quality of life, including pain, mobility, and emotional wellbeing. Each participant will be closely monitored by the clinical team throughout the 12-week study period. If a wound heals earlier, the participant will finish the study at that time. If the wound does not heal, the participant may return to their regular physician for follow-up care.

Eligibility Criteria

Inclusion Criteria: 1. Age 18 or older and able to provide informed consent. 2. Has an open wound or ulceration, preferably with tunneling or undermining. 3. If multiple wounds/ulcerations are present, only one will be selected for Miro3D treatment. 4. Other wounds must be ≥2 cm away from the study wound. 5. Wound should be debrided with a clinical goal of healing, even if some infection remains. 6. Previous infections must be adequately treated and controlled (per IDSA guidelines). 7. Willing and able to comply with offloading and/or compression requirements. 8. Must have a stable living environment for wound care adherence. 9. Study wound must have a clean base free of devitalized tissue or debris at the time of Miro3D placement. 10. Provides consent for digital photo documentation. Exclusion Criteria: 1. Active, untreated osteomyelitis. 2. Malignancy or vasculitis at the wound site. 3. Undergoing chemotherapy. 4. On dialysis. 5. Use of investigational drugs or therapies within 30 days before screening. 6. Conditions that significantly impair study adherence or known history of medical non-compliance. 7. Known sensitivity to porcine materials. 8. Third-degree burns. 9. Worsening ischemia or gangrene at screening. 10. Prior radiation to the study wound site. 11. Exposed hardware, implants, or fixation devices in the study wound. 12. Receiving palliative or comfort care.

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