Miro3D Wound Matrix for Diabetic Foot Ulcers

(STRIDDDE Trial)

Recruiting at 2 trial locations

Overseen By Maria Swartz

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Reprise Biomedical, Inc.

Must not be taking: Investigational drugs

Disqualifiers: Poorly controlled diabetes, Osteomyelitis, Chemotherapy, Dialysis, others

Stay on Your Current Meds You can continue your current medications while participating

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

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Miro3D Wound Matrix to determine if it heals diabetic foot ulcers more effectively than standard care alone. The study will compare two groups: one receiving Miro3D with regular wound care and the other receiving only regular care. The goal is to determine if Miro3D leads to faster or more complete healing. Ideal candidates for this trial have a diabetic foot ulcer present for at least four weeks that hasn't healed well with regular care. As an unphased trial, this study offers a unique opportunity to potentially benefit from an innovative treatment while contributing to important research.

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 prior data suggests that the Miro3D Wound Matrix is safe for treating diabetic foot ulcers?

Research has shown that the Miro3D Wound Matrix is generally safe for use. In a study on diabetic foot ulcers, participants reported no harmful effects from the treatment, indicating no side effects directly caused by Miro3D. Additionally, the FDA has approved the Miro3D Wound Matrix, confirming it has passed safety tests for treating wounds. While this is reassuring, each person's experience may vary, and ongoing studies continue to explore how well individuals tolerate the treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for diabetic foot ulcers, which typically involves wound cleaning, debridement, offloading, and dressings, the Miro3D Wound Matrix offers a unique approach by incorporating a 3D-printed scaffold that promotes tissue regeneration. This innovative matrix is applied directly to the wound and provides a structured environment that may enhance the body's natural healing processes more effectively than traditional methods. Researchers are excited because this treatment has the potential to not only speed up healing but also improve overall wound quality, reducing the risk of complications and the need for more aggressive interventions like surgery.

What evidence suggests that the Miro3D Wound Matrix is effective for diabetic foot ulcers?

Research has shown that using the Miro3D Wound Matrix with standard care might accelerate the healing of diabetic foot ulcers. In this trial, one group of participants will receive the Miro3D Wound Matrix alongside standard care. The Miro3D is a specialized wound covering made from pigs that promotes faster skin regeneration. Studies have found that similar wound coverings can enhance healing and lower the risk of amputation. Early results suggest this treatment helps wounds close more quickly and completely, potentially reducing pain and improving quality of life for individuals with these wounds. ^{1 5 6 7 8}

Who Is on the Research Team?

Robert J. Snyder, DPM

Principal Investigator

Barry University

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Miro3D Wound Matrix plus Standard of Care (SOC) Experimental Treatment 2 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) Alone Active Control 1 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.

Who Is Running the Clinical Trial?

Reprise Biomedical, Inc.

Lead Sponsor

Barry University

Collaborator

Trials

1

Recruited

310+

Icahn School of Medicine at Mount Sinai

Collaborator

Trials

933

Recruited

579,000+

Published Research Related to This Trial

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial comparing OASIS Wound Matrix to Regranex Gel for diabetic ulcers. Niezgoda, JA., Van Gils, CC., Frykberg, RG., et al.[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]

A literature review of three clinical trials involving 154 patients showed that the human acellular dermal wound matrix (HADWM) significantly reduced the mean healing time of diabetic foot ulcers (DFUs) by 1.7 weeks compared to standard moist wound care.

Patients treated with HADWM had nearly four times the chance of healing their ulcers compared to those receiving standard care, indicating that HADWM could be a more effective option for difficult-to-heal wounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Human acellular dermal wound matrix for treatment of DFU: literature review and analysis. Reyzelman, AM., Bazarov, I.[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.

trialx.com

trialx.com/clinical-trials/listings/297278/study-of-miro3d-wound-matrix-for-healing-wounds-and-ulcers-in-outpatient-care/

Study of Miro3D Wound Matrix for Healing ...

The study investigates Miro3D's real-world impact on wound healing in adult subjects presenting with chronic or complex wounds, including but ...

3.

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 ...

4.

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 ...

This case series examines the use of 3D-ACM in treating diabetic foot ulcers (DFUs) that are deep, tunnelling, undermining, or irregularly ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10877811/

Effectiveness and safety of dermal matrix used for diabetic foot ...

The application of dermal matrix as an adjuvant therapy in conjunction with SOC effectively improved the healing process of DFUs and reduced the amputation ...

6.

accessdata.fda.gov

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

K221520.pdf - accessdata.fda.gov

The Reprise Miro3D Wound Matrix is a sterile, single use, non-crosslinked acellular wound dressing that is derived from porcine liver tissue.

7.

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 a prospective, post-market, proof-of-concept trial evaluating the safety and effectiveness of Miro3D Wound Matrix, a ...

8.

trialx.com

trialx.com/clinical-trials/listings/323880/miro3d-wound-matrix-study-for-diabetic-foot-ulcers-and-wound-healing/

Miro3D Wound Matrix Study for Diabetic Foot Ulcers and ...

... Miro3D is expected to demonstrate a favorable safety profile. Regulatory, Ethical, and Clinical Context: Miro3D Wound Matrix is FDA-cleared ...