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RECRUITING

NCT07347106

Miro3D Randomized Controlled Trial (RCT)

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-01

Completion Date

2028-07

Last Updated

2026-01-20

Healthy Volunteers

Conditions

Wound

Interventions

OTHER

Standard 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.

OTHER

Standard 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.

Inclusion Criteria: * Subjects must fulfill all the following inclusion criteria to qualify for enrollment: 1. Men or women 18-90 years of age at enrollment. 2. Ability to sign consent by subject or LAR. 3. Wounds in one of the two arms: * A. Soft tissue wounds with a minimum size of 1 cm x 1 cm surface area and a maximum size of 40 cm L x 20 cm W x 5 cm D, resulting from either post-fasciotomy or post-NSSTI, including the pelvis with the lower extremity. Fasciotomies must have undergone complete debridement and, in the opinion of a trial investigator, be appropriate for wound healing but not ready for primary closure at randomization. * B. Chronic, complex pressure ulcers classified as Stage III or higher, located in the decubitus or ischial region, that have not achieved at least a 50% reduction in ulcer area despite receiving documented SOC treatment for a minimum of four (4) weeks, with confirmed patient compliance. 4. Subjects must agree to proper offloading and/or compression of the wound or ulcer throughout the trial. 5. Written informed consent is required for digital photo imaging. 6. For the Miro3D plus SOC arm, the wound or ulcer must have a clean base that is free of devitalized tissue or debris at the time of Miro3D placement. 7. Subjects receiving NPWT at baseline are eligible for enrollment. The use of NPWT during the trial will be at the discretion of the treating provider. Exclusion Criteria: * Subjects who meet any of the following criteria will be excluded from trial participation: 1. The PAR of the pressure ulcer arm has reduced by 50% or more after four (4) weeks of SOC. 2. Wounds with active invasive infection not yet controlled in the opinion of a trial investigator. 3. Wounds with vascular insufficiencies requiring revascularization. 4. Trial investigator deems the subject has no meaningful wound healing potential (e.g., advanced cancer, severe malnutrition) and/or has conditions that seriously compromise the subject's ability to complete the trial or a known history of non-adherence to medical care. 5. Undergoing chemotherapy. 6. History of radiation to the area of the index wound or ulcer, regardless of time since last radiation treatment. 7. Use of investigational drugs or therapies within thirty (30) days before screening. 8. On dialysis. 9. Sensitivity, allergy, or contraindication to Miro3D and/or NPWT or its components. 10. Presence of third-degree burns. 11. Index wound or ulcer exhibiting worsening ischemia or gangrene at screening. 12. Subjects moving toward palliative or comfort care.

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States