Miro3D Randomized Controlled Trial (RCT)
Sponsor: Washington University School of Medicine • ClinicalTrials.gov ID: NCT07347106
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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.
Interventions
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Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound Matrix
(Other)
Subjects with lower extremity three-dimensional tissue defects, including those resulting from elevated calf intra-compartmental hypertension treated with decompressive fasciotomies or serious NSSTIs of the foot or lower extremities (including the pelvis as part of the lower extremity). These defects must have been controlled with surgical debridement. Subjects will be randomized to either SOC alone or SOC plus the application of Miro3D tissue scaffolding.
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Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound Matrix
(Other)
Subjects with complex pressure ulcerations, particularly decubitus or ischial pressure ulcerations (Stage III or greater). These subjects will be randomized to either SOC alone or SOC plus Miro3D tissue scaffolding.
Eligibility criteria
Conditions
Locations
- Washington University School of Medicine — St Louis, Missouri, United States
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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