RecruitingNot ApplicableNCT07347106

Miro3D Randomized Controlled Trial (RCT)

A Prospective, Randomized Controlled Trial of Miro3D Wound Matrix With Standard of Care Versus Standard of Care Alone in Treating Acute Soft Tissue Wounds and Chronic Pressure Ulcerations

Sponsor

Washington University School of Medicine

Enrollment

70 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Wound

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound Matrix and Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound Matrix for people with wound. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 90 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERStandard of Care Treatment or Standard of Care Treatment plus Miro3D Wound Matrix

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.

OTHERStandard of Care Treatment or Standard of Care Treatment plus Miro3D Wound Matrix

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.