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

Launched by REPRISE BIOMEDICAL, INC. · Apr 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new wound dressing called Miro3D Wound Matrix to see how well it helps heal tough wounds and ulcers in patients receiving outpatient care. Miro3D is made from pig liver tissue that has been processed to create a clean support structure for the body's natural healing process. The trial aims to find out how effective Miro3D is when used alongside regular wound care, with a focus on how much the wounds shrink, the formation of healthy new tissue, and how the treatment affects patients’ pain and overall quality of life.

To participate, individuals must be 18 or older, have an open wound or ulcer (especially with tunneling or undermining), and be able to follow wound care instructions. The study will involve around 20 adults who will receive standard wound care plus Miro3D applications for the first four weeks, followed by additional treatments every two weeks if needed, up to a total of 12 weeks. Participants will visit the clinic weekly for assessments and to share their experiences regarding pain and daily life. This study is important because it aims to improve healing outcomes for people with challenging wounds and to help enhance their overall well-being during the treatment process.

Gender

ALL

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.