Recruiting

Miro3D Wound Matrix

Sponsor:

Reprise Biomedical, Inc.

Code:

NCT06939673

Conditions

Diabetic Foot Ulcers (DFUs)

Venous Leg Ulcers (VLUs)

Pressure Ulcers

Surgical Wound Dehiscence (SWD)

Chronic Wounds

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acellular Porcine-Derived Wound Matrix

Study Details

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. 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.

Conditions

Diabetic Foot Ulcers (DFUs)

Venous Leg Ulcers (VLUs)

Pressure Ulcers

Surgical Wound Dehiscence (SWD)

Chronic Wounds

Study ID

NCT06939673

Start date

Feb 29, 2024

Status verified date

Dec, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Miro3D Wound Matrix plus Standard of Care (SOC)

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.

Interventions

Acellular Porcine-Derived Wound Matrix

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.

Primary outcome measure

  • Percent Area Reduction (PAR) and Granulation Tissue Formation at 4 and 12 Weeks [ Time Frame: 4 weeks and 12 weeks post-initial treatment ]

Central Contacts and Locations

Central contacts

Maria Swartz

954-721-4806mswartz@barry.edu

Locations

Barry University Clinical Research

Recruiting

Tamarac, Florida, United States, 33321

Contacts

Maria Swartz

954-721-4806mswartz@barry.edu

Principal Investigator:

Cherison Cuffy, DPM

More Information

Sponsor

Reprise Biomedical, Inc.

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Reprise Biomedical, Inc. on 2025-12-24.