Using Miro3D Wound Matrix to Heal Diabetic Foot Ulcers

A Randomized Controlled Trial Evaluating Reprise Biomedical's Miro3D Wound Matrix and Standard of Care Versus Standard of Care Alone in Treating Wagner Grade 1 Diabetic Foot Ulcers and Dehiscence

This study is testing if adding a special wound dressing called Miro3D to regular care can help people with early-stage diabetic foot ulcers heal faster.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Reprise Biomedical, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 3 sites (Coconut Creek, Florida and 2 other locations)
• Trial ID: NCT06939686 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of the Miro3D Wound Matrix in combination with standard care for treating Wagner Grade 1 diabetic foot ulcers. It is a prospective, randomized controlled trial that aims to determine if the addition of this acellular, porcine-derived wound matrix enhances healing outcomes compared to standard care alone. The study will measure early wound healing progress at four weeks and assess complete healing by twelve weeks. The trial is sponsored by Reprise Biomedical, Inc. and conducted at Barry University in Florida.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with Wagner Grade 1 diabetic foot ulcers that have been present for at least four weeks.

Not a fit: Patients with ulcers that do not meet the inclusion criteria or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve healing rates for patients with diabetic foot ulcers, reducing the risk of complications and amputations.

How similar studies have performed: Previous studies have shown promise with advanced biologic matrices in wound healing, suggesting potential for success with this approach.

Eligibility criteria

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.

Where this trial is running

Coconut Creek, Florida and 2 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)
• Icahn School of Medicine at Mount Sinai — New York, New York, United States (Not_yet_recruiting)

Study contacts

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

Conditions Diabetic Foot Ulcers; Chronic Wound of the Lower Limb; Diabetic Foot Ulcer; Chronic Wound Healing; Miro3D Wound Matrix; Acellular Wound Scaffold; Porcine-derived Wound Matrix; Biologic Wound Matrix