Miro3D Wound Matrix for Diabetic Foot Ulcers
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are using investigational drugs or therapies, you must stop them at least 30 days before screening.
What data supports the effectiveness of the treatment Miro3D Wound Matrix for diabetic foot ulcers?
Research on similar treatments, like the injectable porcine collagen-derived matrix, shows promising results in healing diabetic foot ulcers, with a 72% reduction in wound size in a pilot study. Additionally, a study on a resorbable glass microfiber matrix showed that 70% of treated diabetic foot ulcers healed compared to 25% with standard care, suggesting that advanced wound matrices can significantly improve healing.12345
Is the Miro3D Wound Matrix safe for use in humans?
How does the Miro3D Wound Matrix treatment differ from other treatments for diabetic foot ulcers?
The Miro3D Wound Matrix is unique because it uses a resorbable glass microfiber matrix, which significantly improves wound healing compared to standard care. In a study, 70% of wounds treated with this matrix healed in 12 weeks, compared to only 25% with standard care, showing its effectiveness in promoting faster and more complete healing.12459
What is the purpose of this trial?
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 diabetic foot ulcers (DFUs) and wound dehiscence in an outpatient setting. The trial is sponsored by Reprise Biomedical, Inc. and aims to explore whether the addition of Miro3D-a three-dimensional, acellular porcine-derived wound matrix-enhances wound healing outcomes compared to SOC alone.Purpose of the Study: The primary purpose of the study is to determine whether applying Miro3D in combination with SOC leads to improved healing of diabetic foot ulcers compared to SOC alone. Specifically, the study seeks to assess early wound healing progress at four weeks (as measured by percent area reduction and granulation tissue formation) as a predictor of complete healing by twelve weeks.Key Question the Study Seeks to Answer: Does the addition of Miro3D to standard wound care improve the healing rate and overall wound outcomes for patients with Wagner Grade 1 diabetic foot ulcers or dehisced wounds compared to standard care alone?Study Design Overview: Subjects who meet inclusion/exclusion criteria will be randomized into one of two groups:1. Miro3D + SOC arm - receiving Miro3D weekly for 4 weeks, then biweekly if needed, for up to 12 weeks.2. SOC alone (control) arm - receiving SOC without Miro3D. If the wound remains unhealed at 12 weeks in the SOC alone arm, participants may "crossover" to receive Miro3D treatment under the same schedule for an additional 12 weeks.Primary Endpoint:1. Percent Area Reduction (PAR) and granulation tissue formation at 4 weeks, serving as predictors for wound healing at 12 weeks.Secondary Endpoints:1. Quality of Life (QOL) improvements, including pain, mobility, and emotional well-being, assessed using a validated Wound/Ulcer-QOL tool.2. Pain levels using a Visual Analog Scale (VAS) at each visit.Population: Approximately 30 adult subjects (15 per arm) with Wagner Grade 1 diabetic foot ulcers or dehisced wounds will be enrolled. Subjects must have adequate blood flow, demonstrate wound size criteria, and commit to offloading and follow-up care.Follow-Up: Subjects will be followed weekly through the 12-week study period. Healed subjects will undergo confirmation visits at 2 and 4 weeks post-closure. Subjects in the crossover arm will be followed for an additional 12 weeks if their wound was unhealed at the primary endpoint.Statistical Considerations: Data will be summarized using descriptive statistics, including wound measurements, infection status, and healing rates. Comparative analysis will be conducted between treatment groups and schedules (weekly vs. biweekly Miro3D application). Adverse events (AEs), serious adverse events (SAEs), and device-related events will also be documented.This study aims to generate clinical evidence supporting the use of Miro3D as a beneficial adjunct to standard wound care in promoting early and complete healing of diabetic foot ulcers.
Research Team
Robert J. Snyder, DPM
Principal Investigator
Barry University
Eligibility Criteria
This trial is for adults with Wagner Grade 1 diabetic foot ulcers or dehisced wounds. Participants must have good blood flow, meet wound size requirements, and be committed to offloading and follow-up care. It's not clear who can't join because the exclusion criteria are not provided.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Miro3D Wound Matrix plus Standard of Care or Standard of Care alone for up to 12 weeks
Crossover
Participants in the SOC arm with unhealed wounds at 12 weeks may crossover to receive Miro3D treatment for an additional 12 weeks
Follow-up
Participants are monitored for sustained wound closure and safety
Treatment Details
Interventions
- Miro3D Wound Matrix
Find a Clinic Near You
Who Is Running the Clinical Trial?
Reprise Biomedical, Inc.
Lead Sponsor
Barry University
Collaborator