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.
Miro3D Wound Matrix Study for Diabetic Foot Ulcers and Wound Healing
At a glance
Conditions
Where it's being run
3 sites across 2 statesStudy leadership
- Robert J. Snyder, DPM · PRINCIPAL_INVESTIGATOR · Barry University
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- 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.