Miro3D Wound Matrix Study for Diabetic Foot Ulcers and Wound Healing

NCT06939686 | Recruiting FDA Device

• 2 other identifiers: REPRISE00220243362
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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. 1.Miro3D + SOC arm - receiving Miro3D weekly for 4 weeks, then biweekly if needed, for up to 12 weeks.
2. 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.
3. 3.Quality of Life (QOL) improvements, including pain, mobility, and emotional well-being, assessed using a validated Wound/Ulcer-QOL tool.
4. 4.Pain levels using a Visual Analog Scale (VAS) at each visit.

Conditions

Diabetic Foot Ulcers (DFUs); Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)

Keywords

Diabetic Foot Ulcer; Chronic Wound Healing; Miro3D Wound Matrix; Acellular Wound Scaffold; Porcine-derived Wound Matrix; Biologic Wound Matrix; Wound Granulation; Percentage Area Reduction; Reprise Biomedical

Outcome Measures

Primary Outcomes (1)

• Percent Area Reduction (PAR) and Granulation Tissue Formation at 4 Weeks

  The primary endpoint is the percent area reduction (PAR) and granulation tissue formation of the index wound or ulcer measured at 4 weeks. This serves as a predictor of complete healing by week 12. Wound size is measured manually using a ruler, and depth is assessed with a probe. Granulation is visually assessed by trained clinicians.

  4 weeks post-randomization

Secondary Outcomes (3)

• Complete Wound or Ulcer Healing by Week 12

  Up to 12 weeks post-randomization

• Quality of Life (QOL) Assessment Using Wound-QOL Instrument

  Baseline, Week 4, Week 8, and Week 12 or at early termination

• Pain Score Assessment Using Visual Analog Scale (VAS)

  Collected at every study visit (weekly through week 12)

Other Outcomes (2)

• Healing Trajectory at Weeks 6 and 8

  6 weeks and 8 weeks post-randomization

• Safety Profile: Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Device Effects (UADEs)

  From informed consent through 30 days post-final study visit

Study Arms (2)

Miro3D Wound Matrix plus Standard of Care (SOC)

EXPERIMENTAL

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.

Device: Miro3D Wound Matrix; Other: Standard of Care (SOC)

Standard of Care (SOC) Alone

ACTIVE COMPARATOR

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.

Other: Standard of Care (SOC)

Interventions

Miro3D Wound Matrix DEVICE

Miro3D is a sterile, acellular, three-dimensional biologic wound matrix derived from porcine liver via perfusion decellularization and drying. It is trimmed to fit the wound and rehydrated with sterile saline or Lactated Ringer's solution before application. It provides a porous scaffold to support granulation and healing in chronic or post-surgical wounds.

Also known as: Miro3D

Miro3D Wound Matrix plus Standard of Care (SOC)

Standard of Care (SOC) OTHER

SOC includes standard wound care practices such as wound cleansing, debridement, infection management (if applicable), use of protective dressings (e.g., Aquacel or foam covered with Adaptic), and offloading devices (e.g., Foot Defender boot) to relieve pressure on the wound.

Also known as: SOC

Miro3D Wound Matrix plus Standard of Care (SOC); Standard of Care (SOC) Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be at least 18 years of age and capable of providing informed consent.
• Must have a full- or partial-thickness Wagner Grade 1 ulcer or wound on the foot; if involving the malleolus, no more than 50% of the wound may be above the midpoint of the medial malleolus.
• Index wound/ulcer must be between 1 cm² and 20 cm² post-debridement.
• Wound/ulcer must have been present for at least 4 weeks prior to screening.
• 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.
• Other wounds, if present, must be at least 2 cm from the index wound/ulcer.
• Any previous infections must have been adequately treated per IDSA guidelines.
• Subjects must agree to proper offloading and/or compression, have a stable living environment, and be able to attend follow-up visits.
• Must provide written consent for digital imaging.
• For Miro3D arm: Index wound/ulcer must have a clean base free of devitalized tissue or debris at the time of product placement.

You may not qualify if:

• Index wound/ulcer has reduced ≥30% after two weeks of SOC from screening to baseline.
• Poorly controlled diabetes (HbA1c ≥ 12%).
• Active, untreated or uncontrolled osteomyelitis.
• Malignancy or vasculitis at the wound site.
• Undergoing chemotherapy.
• On dialysis.
• Use of investigational drugs or therapies within 30 days prior to screening.
• Conditions that would compromise study participation or adherence.
• Known sensitivity to porcine materials.
• Third-degree burns.
• Worsening ischemia or gangrene at screening.
• History of radiation to the wound site.
• Exposed internal fixation, implants, or hardware in the wound.
• Patient is transitioning to palliative or comfort care.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: collaborator
• Reprise Biomedical, Inc.: lead
• Barry University: collaborator

Study Sites (3)

West Boca Center for Wound Healing

Coconut Creek, Florida, 33073, United States

NOT YET RECRUITING

Barry University Clinical Research

Tamarac, Florida, 33321, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

NOT YET RECRUITING

Related Publications (9)

• Warriner RA, Snyder RJ, Cardinal MH. Differentiating diabetic foot ulcers that are unlikely to heal by 12 weeks following achieving 50% percent area reduction at 4 weeks. Int Wound J. 2011 Dec;8(6):632-7. doi: 10.1111/j.1742-481X.2011.00860.x. Epub 2011 Sep 23.

  PMID: 21951763 BACKGROUND

• Snyder RJ, Cardinal M, Dauphinee DM, Stavosky J. A post-hoc analysis of reduction in diabetic foot ulcer size at 4 weeks as a predictor of healing by 12 weeks. Ostomy Wound Manage. 2010 Mar 1;56(3):44-50.

  PMID: 20368673 BACKGROUND

• Smith ME, Totten A, Hickam DH, Fu R, Wasson N, Rahman B, Motu'apuaka M, Saha S. Pressure ulcer treatment strategies: a systematic comparative effectiveness review. Ann Intern Med. 2013 Jul 2;159(1):39-50. doi: 10.7326/0003-4819-159-1-201307020-00007.

  PMID: 23817703 BACKGROUND

• Raghav A, Khan ZA, Labala RK, Ahmad J, Noor S, Mishra BK. Financial burden of diabetic foot ulcers to world: a progressive topic to discuss always. Ther Adv Endocrinol Metab. 2018 Jan;9(1):29-31. doi: 10.1177/2042018817744513. Epub 2017 Dec 12.

  PMID: 29344337 BACKGROUND

• Padula WV, Delarmente BA. The national cost of hospital-acquired pressure injuries in the United States. Int Wound J. 2019 Jun;16(3):634-640. doi: 10.1111/iwj.13071. Epub 2019 Jan 28.

  PMID: 30693644 BACKGROUND

• Mervis JS, Phillips TJ. Pressure ulcers: Pathophysiology, epidemiology, risk factors, and presentation. J Am Acad Dermatol. 2019 Oct;81(4):881-890. doi: 10.1016/j.jaad.2018.12.069. Epub 2019 Jan 18.

  PMID: 30664905 BACKGROUND

• Kruger EA, Pires M, Ngann Y, Sterling M, Rubayi S. Comprehensive management of pressure ulcers in spinal cord injury: current concepts and future trends. J Spinal Cord Med. 2013 Nov;36(6):572-85. doi: 10.1179/2045772313Y.0000000093. Epub 2013 May 21.

  PMID: 24090179 BACKGROUND

• Geriatric Medicine Gerontology Chapter 30 - Pressure Ulcers. (n.d.). Retrieved from Johns Hopkins: https://www.hopkinsmedicine.org/geriatric_medicine_gerontology/_downloads/readings/section8.pdf

  BACKGROUND

• Bauer K, Rock K, Nazzal M, Jones O, Qu W. Pressure Ulcers in the United States' Inpatient Population From 2008 to 2012: Results of a Retrospective Nationwide Study. Ostomy Wound Manage. 2016 Nov;62(11):30-38.

  PMID: 27861135 BACKGROUND

Related Links

• Miro3D Wound Matrix product webpage

MeSH Terms

Conditions

Diabetic Foot; Leg Ulcer; Foot Ulcer

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Foot Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Robert J. Snyder, DPM

  Barry University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Swartz

CONTACT

954-721-4806; mswartz@barry.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Eligibility for Crossover: Subjects randomized to the SOC alone (control) arm who do not achieve complete healing of the index wound or ulcer by Week 12 are eligible to crossover into the Miro3D treatment phase. Crossover Treatment Plan: 1. Subjects who opt into the crossover arm will begin treatment with Miro3D Wound Matrix plus SOC. 2. Miro3D is applied weekly for the first 4 weeks. 3. If the wound/ulcer remains unhealed after 4 weeks, application switches to biweekly (every 14 days). 4. Treatment continues until healing is achieved or up to 12 weeks post-crossover, whichever comes first. Assessments During Crossover: Subjects are monitored weekly for: 1. Percent Area Reduction (PAR) 2. Granulation tissue formation 3. Pain and Quality of Life (QOL) assessments 4. Adverse Events (AEs) or Serious Adverse Events (SAEs)

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 23, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)