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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound Matrix
Other interventionSubjects 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.
Standard of Care Treatment or Standard of Care Treatment plus Miro3D Wound Matrix
Other interventionSubjects 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.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Complex soft tissue wound armActive comparator 1 intervention
Group B: Chronic pressure ulceration armActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 weeksSecondary outcomes
1
Assess frequency of MIRO3D applications over a 12-week treatment period
Frequency of MIRO3D applications
Time frame
12 weeks2
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 weeks3
Assess NPWT use
Frequency of NPWT use
Time frame
12 weeks4
Assess cellular findings from tissue sampling
Prescence of bacteria or fungus, blood vessels and new healing cells on pathology
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov