Using Miro3D Wound Matrix to Heal Complex Wounds

A Clinical Study of Reprise Biomedical's Miro3D Wound Matrix in the Outpatient Management of Wounds and Ulcerations

This study is testing if a new wound treatment made from pig liver can help heal tough wounds and reduce pain for adults with chronic ulcers and other serious skin issues.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Reprise Biomedical, Inc. (industry)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Coconut Creek, Florida and 1 other locations)
• Trial ID: NCT06939673 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the effectiveness of Miro3D Wound Matrix, a biologically derived acellular scaffold made from porcine liver tissue, in healing complex wounds and ulcerations in an outpatient setting. The trial is designed as a post-market, proof-of-concept evaluation, where the Miro3D matrix is applied alongside standard wound care practices. Up to 20 adult participants with chronic wounds such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, or surgical wound dehiscence will be enrolled to assess the matrix's impact on wound closure and pain reduction over a 12-week treatment phase.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older with open wounds or ulcerations that exhibit tunneling or undermining.

Not a fit: Patients with active untreated osteomyelitis, malignancies at the wound site, or those undergoing chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve healing outcomes for patients with difficult-to-treat chronic wounds.

How similar studies have performed: While this approach is innovative, it builds on existing knowledge of biologically derived wound matrices, and similar studies have shown promise in wound healing.

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.

Where this trial is running

Coconut Creek, Florida and 1 other locations

• West Boca Center for Wound Healing — Coconut Creek, Florida, United States (NOT_YET_RECRUITING)
• Barry University Clinical Research — Tamarac, Florida, United States (RECRUITING)

Study contacts

• Principal investigator: Robert J. Snyder, DPM — Barry University
• Study coordinator: Maria Swartz

Conditions: Diabetic Foot Ulcers, Venous Leg Ulcers, Pressure Ulcers, Surgical Wound Dehiscence, Chronic Wounds, Undermined and Tunneling Wounds, Miro3D Wound Matrix, Acellular Wound Matrix