Status:
RECRUITING
Miro3D Wound Matrix Study for Diabetic Foot Ulcers and Wound Healing
Lead Sponsor:
Reprise Biomedical, Inc.
Collaborating Sponsors:
Barry University
Icahn School of Medicine at Mount Sinai
Conditions:
Diabetic Foot Ulcers (DFUs)
Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is a prospective, randomized controlled trial designed to evaluate the effectiveness of Miro3D Wound Matrix plus Standard of Care (SOC) compared to SOC alone in treating Wagner Grade 1 diab...
Detailed Description
This prospective, randomized controlled trial evaluates the clinical effectiveness of Reprise Biomedical's Miro3D Wound Matrix in conjunction with standard of care (SOC) compared to SOC alone in treat...
Eligibility Criteria
Inclusion
- Must be at least 18 years of age and capable of providing informed consent.
- Must have a full- or partial-thickness Wagner Grade 1 ulcer or wound on the foot; if involving the malleolus, no more than 50% of the wound may be above the midpoint of the medial malleolus.
- Index wound/ulcer must be between 1 cm² and 20 cm² post-debridement.
- Wound/ulcer must have been present for at least 4 weeks prior to screening.
- Adequate circulation must be documented by one of the following: ABI between 0.7-1.2, TBI ≥ 0.7, TCPO2 ≥ 40 mmHg, or triphasic/biphasic Doppler waveforms.
- Other wounds, if present, must be at least 2 cm from the index wound/ulcer.
- Any previous infections must have been adequately treated per IDSA guidelines.
- Subjects must agree to proper offloading and/or compression, have a stable living environment, and be able to attend follow-up visits.
- Must provide written consent for digital imaging.
- For Miro3D arm: Index wound/ulcer must have a clean base free of devitalized tissue or debris at the time of product placement.
Exclusion
- Index wound/ulcer has reduced ≥30% after two weeks of SOC from screening to baseline.
- Poorly controlled diabetes (HbA1c ≥ 12%).
- Active, untreated or uncontrolled osteomyelitis.
- Malignancy or vasculitis at the wound site.
- Undergoing chemotherapy.
- On dialysis.
- Use of investigational drugs or therapies within 30 days prior to screening.
- Conditions that would compromise study participation or adherence.
- Known sensitivity to porcine materials.
- Third-degree burns.
- Worsening ischemia or gangrene at screening.
- History of radiation to the wound site.
- Exposed internal fixation, implants, or hardware in the wound.
- Patient is transitioning to palliative or comfort care.
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06939686
Start Date
November 1 2024
End Date
July 31 2026
Last Update
December 24 2025
Active Locations (3)
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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
3
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029