NCT07347106 Miro3D Randomized Controlled Trial (RCT)
| NCT ID | NCT07347106 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington University School of Medicine |
| Condition | Wound |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-11-11 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2025-11-11 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
John Kirby, MD
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT07347106 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Wound. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07347106 currently recruiting?
Yes, NCT07347106 is actively recruiting participants. Contact the research team at aaronday@wustl.edu for enrollment information.
Where is the NCT07347106 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT07347106 clinical trial?
NCT07347106 is sponsored by Washington University School of Medicine. The principal investigator is John Kirby, MD at Washington University School of Medicine. The trial plans to enroll 70 participants.