Using Miro3D Wound Matrix to Heal Diabetic Foot Ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Barry University Clinical Research
  Tamarac, Florida, United States Recruiting
• West Boca Center for Wound Healing
  Coconut Creek, Florida, United States Not yet 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
• Email: mswartz@barry.edu
• Phone: 954-721-4806

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Miro3D Wound Matrix for Diabetic Foot Ulcers

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  Recruiting ConvaTec Inc. · Ashton-under-Lyne, England · NCT07438951

• Using Miro3D Wound Matrix to Heal Complex Wounds

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  Recruiting Reprise Biomedical, Inc. · Coconut Creek, Florida and 1 other locations · NCT06939673

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• Tropocells autologous platelet-rich fibrin for healing mild-to-moderate neuroischemic diabetic foot ulcers

  This will test whether Tropocells autologous platelet-rich fibrin (PRF) helps close mild-to-moderate neuroischemic diabetic foot ulcers in adults with type 1 or type 2 diabetes.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.