Miro3D Wound Matrix Study for Diabetic Foot Ulcers

This study is looking at how well a product called Miro3D Wound Matrix helps heal diabetic foot ulcers (sores on the feet common in people with diabetes) and other chronic lower limb wounds. You would receive either Miro3D Wound Matrix along with standard wound care, or standard wound care alone. Miro3D is a special dressing made from pig liver that helps wounds heal. Researchers want to see if adding Miro3D helps wounds close faster or better than standard care alone. To join, you must be at least 18 years old and have a specific type of diabetic foot ulcer or wound between 1 and 20 square centimeters in size. The study plans to enroll 30 people. The main goal is to see how much the wound area shrinks and how much new tissue forms after 4 weeks.

Study design
This is a randomized controlled trial, meaning participants are assigned by chance to one of two groups. It compares Miro3D Wound Matrix plus standard care to standard care alone, and plans to include 30 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary healing outcomes are measured at 4 weeks after you are assigned to a treatment group.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06939686

Miro3D Wound Matrix Study for Diabetic Foot Ulcers and Wound Healing

Recruiting
NAAges 18+InterventionalTreatment
Reprise Biomedical, Inc.
~30 participants
Updated 2025-12-24 on ClinicalTrials.gov
What's tested:Miro3D Wound MatrixStandard of Care (SOC)

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent Area Reduction (PAR) and Granulation Tissue Formation at 4 Weeks
Measured over 4 weeks post-randomization
Diabetic Foot Ulcers (DFUs)
Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
3 sites across 2 states
Florida2
New York1
  • Robert J. Snyder, DPM · PRINCIPAL_INVESTIGATOR · Barry University

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  • Percent Area Reduction (PAR) and Granulation Tissue Formation at 4 Weeks4 weeks post-randomization

    The primary endpoint is the percent area reduction (PAR) and granulation tissue formation of the index wound or ulcer measured at 4 weeks. This serves as a predictor of complete healing by week 12. Wound size is measured manually using a ruler, and depth is assessed with a probe. Granulation is visually assessed by trained clinicians.