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Miro3D for Complex Wounds and Pressure Ulcers

This study is looking at how well Miro3D Wound Matrix helps heal complex wounds and pressure ulcers. Miro3D is a special 3D framework made of collagen protein that provides structure and protection to help wounds heal. You could be eligible if you are between 18 and 90 years old and have certain soft tissue wounds or pressure ulcers (Stage III or greater). The study compares standard wound care alone to standard care plus Miro3D. Researchers will measure the percentage of wound area reduction after four weeks to see if Miro3D is effective. The current status of this study is unclear.

Study design
This is a randomized controlled trial, meaning participants will be assigned by chance to receive either standard care or standard care plus Miro3D. The study plans to enroll 70 participants.
What's involved
Participants will receive either standard of care treatment or standard of care treatment plus Miro3D Wound Matrix. The study will last for twelve weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 4 weeks after Miro3D placement, and the study evaluates outcomes over a twelve-week timeframe.

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NCT07347106

Miro3D Randomized Controlled Trial (RCT)

Recruiting
NAAges 18–90InterventionalTreatment
Washington University School of Medicine
~70 participants
Updated 2026-08-25 on ClinicalTrials.gov
What's tested:Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound Matrix

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of change defined as Percentage Area Reduction or PAR at four weeks after placement or not of the MIRO3D.
Measured over 4 weeks

Conditions

Wound

Explore related trials

Pressure SoreSoft Tissue Wound

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

  • John Kirby, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Aaron Day, RN
[email protected]
(314) 747-4129
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Subjects who meet any of the following criteria will be excluded from trial participation:

What this trial measures

  • Rate of change defined as Percentage Area Reduction or PAR at four weeks after placement or not of the MIRO3D.4 weeks

    Rate of change