An interventional study of 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 in Wound, sponsored by Washington University School of Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
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.
Acellular tissue scaffolds, such as Miro3D, were developed to aid in the management of complex tissue defect wounds and ulcerations by providing a structural matrix that supports cellular infiltration and tissue regeneration. However, high-quality prospective data remain limited, particularly regarding soft tissue deficits and pressure ulcerations. This prospective RCT is designed to evaluate the efficacy and outcomes of subjects randomized to receive either SOC alone or SOC with the addition of tissue scaffolding techniques (Miro3D) over a twelve (12)-week timeframe.
The trial will investigate two categories of complex wounds: soft tissue wounds, including post-fasciotomy wounds and wounds resulting from necrotizing skin and soft tissue infection (NSSTI), and chronic pressure ulcerations, with a focus on decubitus and ischial pressure ulcers. The trial aims to generate real-world data, including cost-effectiveness parameters, and features a crossover arm to evaluate the impact of delayed wound bed preparation and the application of tissue scaffolds.
Additionally, the trial will evaluate healing quality using digital wound photography and mathematical analysis of wound redness as a surrogate marker for granulation tissue formation. Time to hospital discharge will also be tracked for acute wounds to assess cost and resource utilization. By analyzing the effectiveness of Miro3D in combination with SOC, this trial seeks to provide meaningful insights into optimizing wound management strategies.
5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.
This study's planned enrollment of 70 is above the median of 52 across 3,239 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
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Subjects must fulfill all the following inclusion criteria to qualify for enrollment:
Wounds in one of the two arms:
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from trial participation:
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.
Other: Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound Matrix
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.
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.
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.
Rate of change defined as Percentage Area Reduction or PAR at four weeks after placement or not of the MIRO3D.
Rate of change
Time frame: 4 weeks
Assess frequency of MIRO3D applications over a 12-week treatment period
Frequency of MIRO3D applications
Time frame: 12 weeks
Assess cost of care, including operating room time and time to hospital discharge for acute wounds
Cost of care (dollars as units of cost)
Time frame: 12 weeks
Assess NPWT use
Frequency of NPWT use
Time frame: 12 weeks
Assess cellular findings from tissue sampling
Prescence of bacteria or fungus, blood vessels and new healing cells on pathology
Time frame: 12 weeks
Assess antibiotic use
Frequency of antibiotic use
Time frame: 12 weeks
Assess pain
Subject-reported pain scores using Likert Scale, 0=No Pain - 10=Worst Possible Pain
Time frame: 12 weeks
Assess subject-reported ability to move to self-care
Patients will report if they are able to change their dressing on their own without anyone's assistance versus others having to assist (including if home health was able to be stopped) and when this occurred in their treatment course.
Time frame: 12 weeks
Plan to share: No
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