Miro3D for Wounds
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this research study is to evaluate the outcomes for patients managed with standard of care (SOC) wound treatments and those managed with standard of care treatment and tissue scaffolds, specifically Miro 3D. Tissue scaffolds like Miro 3D are 3-dimentional frameworks for collagen protein that provide structure and protection to help wounds heal.
Who Is on the Research Team?
John Kirby, MD
Principal Investigator
Washington University School of Medicine
Are You a Good Fit for This Trial?
The Miro3D RCT is for men and women aged 18-90 with certain types of wounds, such as post-surgery or chronic pressure ulcers that haven't healed well. Participants must be able to consent, have a wound size within specified limits, comply with treatment protocols like offloading/compression, and allow digital photos. Those with clean wound bases are eligible for the trial arm using Miro3D plus standard care.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Miro3D Wound Matrix
Trial Overview
This study compares standard wound care treatments to those same treatments combined with a tissue scaffold called Miro3D. The goal is to see if adding Miro3D improves healing in difficult-to-heal wounds by providing structure and protection through a collagen framework.
How Is the Trial Designed?
2
Treatment groups
Active Control
The complex soft tissue wound arm will include consented subjects who have three-dimensional tissue defects, either elevated calf intra-compartmental hypertension treated with fasciotomy or serious infections of the foot or lower extremity that have been controlled with surgical debridement. Subjects will be randomized to either SOC alone or SOC plus Miro3D.
The chronic pressure ulceration arm will include consented subjects with three-dimensional tissue deficits resulting from Stage III or greater pressure ulcerations, either a decubitus or ischial pressure ulcer that has been present and treated with SOC for at least four (4) weeks. Subjects will be randomized to SOC plus Miro3D or SOC alone.
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Who Is Running the Clinical Trial?
Washington University School of Medicine
Lead Sponsor
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