Miro3D Wound Matrix for Wounds and Ulcers

Overseen By Maria Swartz

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Reprise Biomedical, Inc.

Must not be taking: Investigational drugs

Disqualifiers: Osteomyelitis, Chemotherapy, Dialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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 from porcine (pig) liver tissue. It is processed to remove all cells, creating a clean scaffold that can support the body's natural healing process. The goal of this study is to see how effective Miro3D is when used alongside standard wound care for helping wounds close and reducing pain and discomfort. The study is designed as a post-market, proof-of-concept trial, meaning the product is already commercially available, and researchers are evaluating how it works in real-world clinical settings. A total of up to 20 adult participants will be enrolled. Participants may have wounds such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, or surgical wound dehiscence. These wounds may be complex in nature, including tunneling or undermining, which often makes them more difficult to treat. Participants will receive standard wound care along with weekly Miro3D applications for the first 4 weeks. If the wound is not fully healed after 4 weeks, Miro3D will then be applied every 2 weeks until healing is achieved or up to 12 weeks total. Throughout the study, participants will return weekly for wound assessments and to complete brief questionnaires about their pain levels and quality of life. The main goals of the study are: 1. To measure how much the wound size shrinks (known as percent area reduction or PAR). 2. To evaluate how much healthy granulation tissue (new tissue) forms in the wound. 3. To compare healing outcomes when Miro3D is used weekly versus every two weeks. 4. To understand how the treatment affects patients' quality of life, including pain, mobility, and emotional wellbeing. Each participant will be closely monitored by the clinical team throughout the 12-week study period. If a wound heals earlier, the participant will finish the study at that time. If the wound does not heal, the participant may return to their regular physician for follow-up care.

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 joining the study.

What data supports the effectiveness of the treatment Miro3D Wound Matrix for wounds and ulcers?

Research on similar treatments, like the SIS Wound Matrix and injectable porcine collagen-derived matrix, shows they can improve healing in chronic ulcers and diabetic foot wounds, suggesting that advanced wound matrices can be effective in promoting wound healing. ^{1 2 3 4 5}

Is the Miro3D Wound Matrix safe for use in humans?

The Miro3D Wound Matrix, evaluated under different names, has been tested in clinical trials for various types of wounds and ulcers. In these studies, including one with a similar product called BBGFM, no adverse events related to the treatment were reported, suggesting it is generally safe for use in humans. ^{4 6 7 8 9}

How is the Miro3D Wound Matrix treatment different from other treatments for wounds and ulcers?

The Miro3D Wound Matrix is unique because it likely involves a three-dimensional structure that can better conform to complex wound shapes, potentially improving healing in wounds that are irregular or deep. This is different from traditional flat wound dressings, which may not fit as well in such wounds. ^{4 10 11 12 13}

Research Team

Robert J. Snyder, DPM

Principal Investigator

Barry University

Eligibility Criteria

Adults with difficult wounds like diabetic foot ulcers, venous leg ulcers, pressure sores, or surgical wound separation can join this study. The trial is for those who are receiving outpatient care and have complex wounds that may be tunneling or undermining.

Inclusion Criteria

Other wounds must be ≥2 cm away from the study wound

Previous infections must be adequately treated and controlled (per IDSA guidelines)

Must have a stable living environment for wound care adherence

Exclusion Criteria

Exposed hardware, implants, or fixation devices in the study wound

Use of investigational drugs or therapies within 30 days before screening

Conditions that significantly impair study adherence or known history of medical non-compliance

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly Miro3D applications for the first 4 weeks, followed by bi-weekly applications if the wound is not healed, up to 12 weeks total

12 weeks

Weekly visits for wound assessments and questionnaires

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Miro3D Wound Matrix

Trial Overview The Miro3D Wound Matrix, a biologic dressing from pig liver tissue designed to aid natural healing, is being tested. Participants will get standard care plus weekly Miro3D applications for up to 12 weeks while their wound size reduction and tissue health are monitored.

Participant Groups

Group I: Miro3D Wound Matrix plus Standard of Care (SOC) Experimental Treatment 1 Intervention

Participants in this single-arm study will receive Miro3D Wound Matrix in addition to standard wound care procedures. Miro3D is applied directly to the debrided wound bed. It will be applied once every 7 days for the first 4 weeks. If the wound has not closed by then, Miro3D will be applied every 14 days through week 12 or until wound closure, whichever comes first. Standard care includes debridement, dressing changes, offloading and/or compression, and infection management as needed. Weekly evaluations are performed to track healing progress.

Who Is Running the Clinical Trial?

Reprise Biomedical, Inc.

Lead Sponsor

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 study of 20 patients with chronic nonhealing lower-extremity ulcers, the synthetic hybrid-scale fiber matrix led to a 100% closure rate for venous leg ulcers and a 94% closure rate for diabetic foot ulcers, demonstrating its efficacy in treating difficult-to-heal wounds.

Overall, 96% of the complex chronic ulcers treated with this matrix closed successfully, highlighting its potential as a critical solution for patients who have not responded to other advanced therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Synthetic Hybrid-Scale Fiber Matrix for the Treatment of Complex Lower-Extremity Wounds. Husain, K., Malik, A., Kirchens, J.[2023]

In a study of 22 patients with hard-to-heal vascular leg ulcers, the advanced flowable wound matrix (FWM) treatment was well tolerated and resulted in a high healing rate, with 85% of ulcers healing within 12 weeks.

FWM treatment also significantly reduced the need for amputations compared to standard wound care, indicating its effectiveness in managing complex wound cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a flowable wound matrix to treat lower limb vascular ulcers. Florio, A., Sallustro, M.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 130 adults with Stage III or IV pressure ulcers, the Oasis® Wound Matrix (SIS) treatment led to a 55% rate of 90% reduction in ulcer size, compared to 38% with standard care, indicating its effectiveness in promoting wound healing.

While the complete healing rate was 40% for the SIS group versus 29% for standard care, the difference was not statistically significant, suggesting that while SIS may enhance healing, it may not guarantee complete healing compared to standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An extracellular matrix graft (Oasis® wound matrix) for treating full-thickness pressure ulcers: A randomized clinical trial. Brown-Etris, M., Milne, CT., Hodde, JP.[2019]

In a 16-week study involving 168 patients, the human acellular dermal matrix DermACELL showed a significantly higher healing rate for diabetic foot ulcers compared to conventional care (67.9% vs 48.1%).

DermACELL also demonstrated a greater average reduction in wound area compared to both conventional care and another acellular dermal matrix, Graftjacket, indicating its potential as an effective treatment option for these ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healing Rates in a Multicenter Assessment of a Sterile, Room Temperature, Acellular Dermal Matrix Versus Conventional Care Wound Management and an Active Comparator in the Treatment of Full-Thickness Diabetic Foot Ulcers. Walters, J., Cazzell, S., Pham, H., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Initial report of the use of an injectable porcine collagen-derived matrix to stimulate healing of diabetic foot wounds in humans. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Personalized prediction of chronic wound healing: an exponential mixed effects model using stereophotogrammetric measurement. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Synthetic Hybrid-Scale Fiber Matrix for the Treatment of Complex Lower-Extremity Wounds. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Use of a flowable wound matrix to treat lower limb vascular ulcers. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Characterization of the local wound environment following treatment of chronic leg ulcers with SIS wound matrix. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Can traumacel be used in the treatment of chronic wounds? [2004]

7. England pubmed.ncbi.nlm.nih.gov

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]

8. United States pubmed.ncbi.nlm.nih.gov

Alternative Wound Management: Translating Science into Practice. [2023]

9. England pubmed.ncbi.nlm.nih.gov

An extracellular matrix graft (Oasis® wound matrix) for treating full-thickness pressure ulcers: A randomized clinical trial. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Use of 3D photography in complex-wound assessment. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Healing Rates in a Multicenter Assessment of a Sterile, Room Temperature, Acellular Dermal Matrix Versus Conventional Care Wound Management and an Active Comparator in the Treatment of Full-Thickness Diabetic Foot Ulcers. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

The clinical effectiveness in wound healing with extracellular matrix derived from porcine urinary bladder matrix: a case series on severe chronic wounds. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Use of a human acellular dermal wound matrix in patients with complex wounds and comorbidities. [2022]