Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care

NCT06939673 | Recruiting FDA Device

• 2 other identifiers: REPRISE00120240306
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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. 1.To measure how much the wound size shrinks (known as percent area reduction or PAR).
2. 2.To evaluate how much healthy granulation tissue (new tissue) forms in the wound.
3. 3.To compare healing outcomes when Miro3D is used weekly versus every two weeks.
4. 4.To understand how the treatment affects patients' quality of life, including pain, mobility, and emotional wellbeing.

Conditions

Diabetic Foot Ulcers (DFUs); Venous Leg Ulcers (VLUs); Pressure Ulcers; Surgical Wound Dehiscence (SWD); Chronic Wounds; Undermined and Tunneling Wounds

Keywords

Miro3D Wound Matrix; Acellular Wound Matrix; Porcine-Derived Scaffold; Chronic Wound Healing; Diabetic Foot Ulcer Treatment; Pressure Ulcer Management; Surgical Wound Dehiscence Therapy; Venous Leg Ulcer Treatment; Tunneling and Undermining Wounds; Complex Wound Management; Reprise Biomedical

Outcome Measures

Primary Outcomes (1)

• Percent Area Reduction (PAR) and Granulation Tissue Formation at 4 and 12 Weeks

  The primary outcome is the measurement of the wound or ulcer's percent area reduction (PAR) and granulation tissue formation at week 4 and week 12. This is used to evaluate healing progression and the effectiveness of Miro3D. Measurements are taken using a ruler for length and width, and a probe for depth. Granulation is assessed visually by the clinical team.

  4 weeks and 12 weeks post-initial treatment

Secondary Outcomes (2)

• Change in Quality of Life (QOL) Using Wound-QOL Instrument

  Baseline and weekly through 12 weeks or until wound closure

• Change in Pain Levels Using Visual Analog Scale (VAS)

  Baseline and weekly through 12 weeks or until wound closure

Other Outcomes (1)

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

  From informed consent through 30 days after final study visit

Study Arms (1)

Miro3D Wound Matrix plus Standard of Care (SOC)

EXPERIMENTAL

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.

Device: Acellular Porcine-Derived Wound Matrix

Interventions

Acellular Porcine-Derived Wound Matrix DEVICE

This intervention is a sterile, acellular, three-dimensional biologic scaffold derived from porcine liver tissue using a proprietary perfusion decellularization and drying process. It retains the native extracellular matrix structure and supports tissue granulation and healing in complex wounds. Miro3D is applied topically to the debrided wound bed and rehydrated prior to use. It is indicated for use in a range of chronic and complex wounds, including diabetic foot ulcers, venous leg ulcers, pressure injuries, and surgical dehiscence. In this study, it is administered in an outpatient setting alongside standard of care treatments.

Also known as: Miro3D Wound Matrix

Miro3D Wound Matrix plus Standard of Care (SOC)

Eligibility Criteria

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

You may qualify if:

• Age 18 or older and able to provide informed consent.
• Has an open wound or ulceration, preferably with tunneling or undermining.
• If multiple wounds/ulcerations are present, only one will be selected for Miro3D treatment.
• Other wounds must be ≥2 cm away from the study wound.
• Wound should be debrided with a clinical goal of healing, even if some infection remains.
• Previous infections must be adequately treated and controlled (per IDSA guidelines).
• Willing and able to comply with offloading and/or compression requirements.
• Must have a stable living environment for wound care adherence.
• Study wound must have a clean base free of devitalized tissue or debris at the time of Miro3D placement.
• Provides consent for digital photo documentation.

You may not qualify if:

• Active, untreated osteomyelitis.
• Malignancy or vasculitis at the wound site.
• Undergoing chemotherapy.
• On dialysis.
• Use of investigational drugs or therapies within 30 days before screening.
• Conditions that significantly impair study adherence or known history of medical non-compliance.
• Known sensitivity to porcine materials.
• Third-degree burns.
• Worsening ischemia or gangrene at screening.
• Prior radiation to the study wound site.
• Exposed hardware, implants, or fixation devices in the study wound.
• Receiving palliative or comfort care.

Sponsors & Collaborators

• Reprise Biomedical, Inc.: lead

Study Sites (2)

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

Related Publications (7)

• 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; Pressure Ulcer; Surgical Wound Dehiscence

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All enrolled participants will receive the same intervention: Miro3D Wound Matrix plus standard of care (SOC). There is no comparator or control arm. The study follows a single-arm, prospective design.

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 23, 2025
• Study Start: February 29, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)