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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how effectively the Miro3D Wound Matrix, a specialized wound dressing made from pig liver tissue, aids in healing stubborn wounds and ulcers. The trial will assess whether using Miro3D alongside regular wound care accelerates wound closure and reduces pain. Individuals with difficult-to-heal wounds, such as diabetic foot ulcers or pressure sores, may qualify if their wounds are complex, featuring tunnels or pockets. Participants will receive the Miro3D treatment weekly for the first month, then every two weeks if necessary, while also reporting on their pain and quality of life. The study seeks to determine how quickly wounds shrink, the extent of new healthy tissue formation, and how these factors enhance daily life. As an unphased trial, this study provides a unique opportunity to contribute to understanding how Miro3D can improve wound healing and quality of life.

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 prior data suggests that the Miro3D Wound Matrix is safe for treating wounds and ulcers?

Research shows that the Miro3D Wound Matrix is generally well-tolerated by patients. Studies have confirmed that it is a sterile, single-use bandage made from pig liver tissue. This material is treated to remove cells, leaving a clean structure that aids natural healing.

In previous studies, participants did not report significant side effects from using the Miro3D Wound Matrix. It has been successfully used to treat various wounds, such as ulcers and surgical wounds. Its availability on the market also suggests it is safe to use.

Overall, existing research and current use indicate that the Miro3D Wound Matrix is safe. Participants in new trials will still be monitored closely to ensure their safety, but past evidence is reassuring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for wounds and ulcers, which typically involves debridement, dressing changes, and infection management, the Miro3D Wound Matrix offers a novel approach by providing a 3D-structured scaffold that supports tissue regeneration directly within the wound. Researchers are excited about this treatment because it not only complements standard practices but potentially accelerates healing by creating a conducive environment for new tissue growth. This innovative application method, which involves applying the matrix directly to the wound bed, could lead to faster and more effective wound closure compared to traditional methods alone.

What evidence suggests that the Miro3D Wound Matrix is effective for healing wounds and ulcers?

A previous study showed that the Miro3D Wound Matrix helps wounds heal effectively. It creates a supportive structure from pig liver tissue, aiding the body's natural healing process. Research has shown that Miro3D can accelerate healing in wounds such as diabetic foot ulcers when combined with regular treatment. Patients treated with Miro3D often experienced reduced wound size and improved appearance. These findings suggest that Miro3D could be effective for wounds and ulcers that are difficult to heal. Participants in this trial will receive the Miro3D Wound Matrix alongside standard wound care procedures to further evaluate its effectiveness. ^{1 2 3 6 7}

Who Is on the Research Team?

Robert J. Snyder, DPM

Principal Investigator

Barry University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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 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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06939686

Miro3D Wound Matrix Study for Diabetic Foot Ulcers and ... This study is designed to evaluate whether the addition of Miro3D to SOC accelerates healing and improves outcomes in Wagner Grade 1 DFUs, a common clinical ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06939673/study-of-miro3d-wound-matrix-for-healing-wounds-and-ulcers-in-outpatient-care

Study of Miro3D Wound Matrix for Healing Wounds and ... This clinical study is being conducted to evaluate how well the Miro3D Wound Matrix helps heal difficult wounds and ulcerations in an ...

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K221520.pdf

K221520.pdf - accessdata.fda.gov The study results indicated that Miro3D performed comparably to MiroDerm in all aspects evaluated. MR compatibility was not evaluated. VIII.

4. withpower.com withpower.com/trial/miro3d-wound-matrix-for-diabetic-foot-ulcers-25f2b

Miro3D Wound Matrix for Diabetic Foot Ulcers This study is a prospective, randomized controlled trial designed to evaluate the effectiveness of Miro3D Wound Matrix plus Standard of Care (SOC) compared ...

5. jwc-woundcentral.com jwc-woundcentral.com/content/practice/use-of-three-dimensional-acellular-collagen-matrix-in-deep-or-tunnelling-diabetic-foot-ulcers-a-retrospective-case-series

Use of three-dimensional acellular collagen matrix in deep ... Additional 3D-ACM was applied as needed. Results: In total, 11 patients with 13 wounds were treated. Improved wound appearance and reduced size ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/K240753.pdf

April 19, 2024 Reprise Biomedical, Inc. Kathy Herzog Sr ... The Miro3D Fibers Wound Matrix is a sterile, single use, non-crosslinked acellular wound dressing that is derived from porcine liver tissue. The ...

7. reprisebio.com reprisebio.com/miro3d/

Miro3D® Wound Matrix Miro3D wound matrix is indicated for the management of wounds, including: partial and full-thickness wounds; pressure ulcers; venous ulcers; chronic vascular ...