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.
Who can participate
Age range18 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Men or women 18-90 years of age at enrollment.
✓. Ability to sign consent by subject or LAR.
✓. Wounds in one of the two arms:
✓. Subjects must agree to proper offloading and/or compression of the wound or ulcer throughout the trial.
✓. Written informed consent is required for digital photo imaging.
✓. 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.
✓. 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
✕. The PAR of the pressure ulcer arm has reduced by 50% or more after four (4) weeks of SOC.
✕. Wounds with active invasive infection not yet controlled in the opinion of a trial investigator.
✕. Wounds with vascular insufficiencies requiring revascularization.
✕. 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.
✕
What they're measuring
1
Rate of change defined as Percentage Area Reduction or PAR at four weeks after placement or not of the MIRO3D.