Miro3D tissue scaffold for complex soft-tissue wounds and pressure ulcers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized controlled trial comparing standard of care (SOC) wound treatment alone versus SOC plus the Miro3D acellular tissue scaffold over a 12-week period. Eligible participants have either complex soft-tissue defects (for example post-fasciotomy or post-necrotizing infection wounds) or chronic Stage III+ pressure ulcers that have not reduced by at least 50% after four weeks of SOC. Outcomes include wound-healing measures (including digital photography and quantitative redness analysis as a surrogate for granulation), time to hospital discharge for acute wounds, and cost-effectiveness parameters, with a planned crossover arm to evaluate delayed scaffold application. The trial collects real-world data to compare healing quality, resource use, and clinical outcomes between the two approaches.

Why it matters

Who can join: the full rules

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.

Where it's running

• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: John Kirby, MD — Washington University School of Medicine
• Study coordinator: Aaron Day, RN
• Email: aaronday@wustl.edu
• Phone: (314) 747-4129

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.