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

RecruitingNAAges 18 Years - anyAllReprise Biomedical, Inc.
NCT06939673 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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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What it tests

  • Acellular Porcine-Derived Wound Matrix
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Where

2 sites
West Boca Center for Wound Healing
Coconut Creek, United States
Barry University Clinical Research
Tamarac, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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