Miro3D Randomized Controlled Trial (RCT)
ConditionWound
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorWashington University School of Medicine
About this trial
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.
Eligibility criteria
Qualifiers
Men or women 18-90 years of age at enrollment.
Ability to sign consent by subject or LAR.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound Matrix
- Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound Matrix
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov