Actively Recruiting
Miro3D Randomized Controlled Trial (RCT)
Led by Washington University School of Medicine · Updated on 2026-01-20
70
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Miro3D Randomized Controlled Trial (RCT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women 18 to 90 years old at enrollment
- Ability to sign consent by subject or legally authorized representative
- Have either a soft tissue wound (1 cm x 1 cm minimum, up to 40 cm x 20 cm x 5 cm max) from post-fasciotomy or post-necrotizing skin and soft tissue infection, with complete surgical debridement
- Or have a chronic, complex pressure ulcer (Stage III or higher) in the decubitus or ischial region, not improved by at least 50% area reduction after at least four weeks of documented standard of care treatment with confirmed compliance
- Agree to proper offloading and/or compression of the wound or ulcer throughout the trial
- Provide written informed consent for digital photo imaging
- For those receiving Miro3D plus standard of care, wound must have a clean base free of devitalized tissue or debris at placement
- Subjects receiving negative pressure wound therapy at baseline are eligible; its use during trial is at provider's discretion
You will not qualify if you...
- Pressure ulcers that have reduced by 50% or more after four weeks of standard of care
- Wounds with active invasive infection not controlled
- Wounds with vascular insufficiencies requiring revascularization
- Subjects with no meaningful wound healing potential or conditions compromising ability to complete trial or history of non-adherence
- Currently undergoing chemotherapy
- History of radiation to the area of the wound
- Use of investigational drugs or therapies within 30 days before screening
- On dialysis
- Sensitivity, allergy, or contraindication to Miro3D or negative pressure wound therapy components
- Presence of third-degree burns
- Wounds showing worsening ischemia or gangrene at screening
- Subjects moving toward palliative or comfort care
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
A
Aaron Day, RN
CONTACT
S
Stacey Reese, RN, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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