Status:
RECRUITING
Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care
Lead Sponsor:
Reprise Biomedical, Inc.
Conditions:
Diabetic Foot Ulcers (DFUs)
Venous Leg Ulcers (VLUs)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This clinical study is being conducted to evaluate how well the Miro3D Wound Matrix helps heal difficult wounds and ulcerations in an outpatient care setting. Miro3D is a biologic wound dressing made ...
Detailed Description
This clinical study is a prospective, post-market, proof-of-concept trial evaluating the safety and effectiveness of Miro3D Wound Matrix, a biologically derived, acellular scaffold developed by Repris...
Eligibility Criteria
Inclusion
- Age 18 or older and able to provide informed consent.
- Has an open wound or ulceration, preferably with tunneling or undermining.
- If multiple wounds/ulcerations are present, only one will be selected for Miro3D treatment.
- Other wounds must be ≥2 cm away from the study wound.
- Wound should be debrided with a clinical goal of healing, even if some infection remains.
- Previous infections must be adequately treated and controlled (per IDSA guidelines).
- Willing and able to comply with offloading and/or compression requirements.
- Must have a stable living environment for wound care adherence.
- Study wound must have a clean base free of devitalized tissue or debris at the time of Miro3D placement.
- Provides consent for digital photo documentation.
Exclusion
- Active, untreated osteomyelitis.
- Malignancy or vasculitis at the wound site.
- Undergoing chemotherapy.
- On dialysis.
- Use of investigational drugs or therapies within 30 days before screening.
- Conditions that significantly impair study adherence or known history of medical non-compliance.
- Known sensitivity to porcine materials.
- Third-degree burns.
- Worsening ischemia or gangrene at screening.
- Prior radiation to the study wound site.
- Exposed hardware, implants, or fixation devices in the study wound.
- Receiving palliative or comfort care.
Key Trial Info
Start Date :
February 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06939673
Start Date
February 29 2024
End Date
December 31 2025
Last Update
December 24 2025
Active Locations (2)
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1
West Boca Center for Wound Healing
Coconut Creek, Florida, United States, 33073
2
Barry University Clinical Research
Tamarac, Florida, United States, 33321