Miro3D Wound Matrix for Healing Wounds and Ulcers
This study is evaluating how well the Miro3D Wound Matrix helps heal difficult wounds and ulcers like diabetic foot ulcers (DFUs), venous leg ulcers (VLUs), pressure ulcers, and surgical wounds that have opened up (surgical wound dehiscence). Miro3D is a special wound dressing made from pig liver tissue that has been processed to create a scaffold, or support structure, for your body's natural healing. Researchers want to see if using Miro3D with standard wound care helps wounds close and form new tissue. Up to 20 adults with open wounds or ulcers can join. The study will measure how much the wound area shrinks and how much new tissue forms after 4 and 12 weeks of treatment.
- Study design
- This is a post-market, proof-of-concept study, meaning the Miro3D Wound Matrix is already available, and researchers are evaluating its use in real-world settings. It is a single-arm study with up to 20 adult participants.
- What's involved
- You would participate in a screening phase and a 12-week treatment phase. The Miro3D Wound Matrix would be applied along with standard wound care.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your wound healing will be assessed at 4 and 12 weeks after the initial treatment.
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Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care
At a glance
Conditions
Where it's being run
2 sites across 1 statesStudy leadership
- Robert J. Snyder, DPM · PRINCIPAL_INVESTIGATOR · Barry University
Who to contact
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What this trial measures
- Percent Area Reduction (PAR) and Granulation Tissue Formation at 4 and 12 Weeks4 weeks and 12 weeks post-initial treatment
The primary outcome is the measurement of the wound or ulcer's percent area reduction (PAR) and granulation tissue formation at week 4 and week 12. This is used to evaluate healing progression and the effectiveness of Miro3D. Measurements are taken using a ruler for length and width, and a probe for depth. Granulation is assessed visually by the clinical team.