30 Participants Needed

Miro3D Wound Matrix for Diabetic Foot Ulcers

MS
Overseen ByMaria Swartz
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

In a clinical trial, the Miro3D Wound Matrix (also known as BBGFM) was used to treat diabetic foot ulcers and showed no adverse events related to the treatment, indicating it is generally safe for use in humans.12678

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

RJ

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

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
Any previous infections must have been adequately treated per IDSA guidelines
Must provide written consent for digital imaging
See 6 more

Exclusion Criteria

Exposed internal fixation, implants, or hardware in the wound
Use of investigational drugs or therapies within 30 days prior to screening
Conditions that would compromise study participation or adherence
See 11 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Treatment

Participants receive Miro3D Wound Matrix plus Standard of Care or Standard of Care alone for up to 12 weeks

12 weeks
Weekly visits (in-person)

Crossover

Participants in the SOC arm with unhealed wounds at 12 weeks may crossover to receive Miro3D treatment for an additional 12 weeks

12 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for sustained wound closure and safety

4 weeks
2 visits (in-person)

Treatment Details

Interventions

  • Miro3D Wound Matrix
Trial Overview The study tests if adding Miro3D Wound Matrix to standard care improves healing of diabetic foot ulcers over a period of up to 12 weeks. Patients will either receive Miro3D plus standard care or just standard care, with an option for those in the latter group to switch after 12 weeks if their wound hasn't healed.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Miro3D Wound Matrix plus Standard of Care (SOC)Experimental Treatment2 Interventions
Subjects randomized to this arm receive Miro3D Wound Matrix in combination with standard of care wound treatment. * Miro3D is applied once every 7 days for the first 4 weeks. * If the wound is not healed after 4 weeks, Miro3D is applied biweekly (every 14 days) through week 12 or until healing. * All subjects in this arm are assessed weekly for healing progress, wound measurements, granulation, pain (VAS), and QOL.
Group II: Standard of Care (SOC) AloneActive Control1 Intervention
Subjects in this arm receive standard wound care without Miro3D, including wound cleaning, debridement, offloading, and appropriate dressings. * Healing progress is evaluated weekly over the 12-week treatment period. * Subjects whose wounds remain unhealed at week 12 may elect to crossover to Miro3D treatment, following the same protocol used in Arm 1.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Reprise Biomedical, Inc.

Lead Sponsor

Barry University

Collaborator

Trials
1
Recruited
310+

Findings from Research

The E-Matrix, a novel injectable scaffolding matrix derived from porcine collagen, shows promise in accelerating wound healing for diabetic foot ulcers, mimicking fetal tissue repair mechanisms.
In a pilot study involving six patients, the E-Matrix led to an impressive average wound size reduction of 72% within just 2 weeks after injection, indicating its potential efficacy in treating chronic nonhealing wounds.
Initial report of the use of an injectable porcine collagen-derived matrix to stimulate healing of diabetic foot wounds in humans.Marston, WA., Usala, A., Hill, RS., et al.[2016]
In a randomized controlled trial involving 40 participants, the resorbable glass microfiber matrix (BBGFM) significantly improved healing rates of diabetic foot ulcers (DFUs) at 12 weeks, with 70% of wounds healed compared to only 25% in the standard of care group.
The BBGFM group also showed a greater reduction in wound area (79% vs. 37%) and improved neuropathic scores, indicating better overall outcomes without any adverse events related to the treatment.
A multi-centre, single-blinded randomised controlled clinical trial evaluating the effect of resorbable glass fibre matrix in the treatment of diabetic foot ulcers.Armstrong, DG., Orgill, DP., Galiano, RD., et al.[2022]
In a study involving 73 patients with diabetic foot ulcers, treatment with OASIS Wound Matrix resulted in a higher healing rate (49%) compared to Regranex Gel (28%) after 12 weeks, suggesting its potential effectiveness.
While the difference in healing rates was not statistically significant (P = .055), the results indicate that OASIS Wound Matrix is at least as effective as Regranex for treating full-thickness diabetic foot ulcers.
Randomized clinical trial comparing OASIS Wound Matrix to Regranex Gel for diabetic ulcers.Niezgoda, JA., Van Gils, CC., Frykberg, RG., et al.[2022]

References

Initial report of the use of an injectable porcine collagen-derived matrix to stimulate healing of diabetic foot wounds in humans. [2016]
A multi-centre, single-blinded randomised controlled clinical trial evaluating the effect of resorbable glass fibre matrix in the treatment of diabetic foot ulcers. [2022]
Randomized clinical trial comparing OASIS Wound Matrix to Regranex Gel for diabetic ulcers. [2022]
Human acellular dermal wound matrix for treatment of DFU: literature review and analysis. [2022]
Use of a human acellular dermal wound matrix in patients with complex wounds and comorbidities. [2022]
Safety and Efficacy of an Autologous Blood Clot Product in the Management of Texas 1A or 2A Neuropathic Diabetic Foot Ulcers: A Prospective, Multicenter, Open Label Pilot Study. [2019]
An observational pilot study using a purified reconstituted bilayer matrix to treat non-healing diabetic foot ulcers. [2021]
Cellular versus acellular grafts for diabetic foot ulcers: altering the protocol to improve recruitment to a comparative efficacy trial. [2018]
Three-dimensional human tissue models that incorporate diabetic foot ulcer-derived fibroblasts mimic in vivo features of chronic wounds. [2018]
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