Recruiting

Miro3D

Sponsor:

Reprise Biomedical, Inc.

Code:

NCT06939686

Conditions

Diabetic Foot Ulcers (DFUs)

Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Miro3D Wound Matrix

Standard of Care (SOC)

Study Details

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. Miro3D + SOC arm - receiving Miro3D weekly for 4 weeks, then biweekly if needed, for up to 12 weeks.
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.

Primary Endpoint:

1\. Percent Area Reduction (PAR) and granulation tissue formation at 4 weeks, serving as predictors for wound healing at 12 weeks.

Secondary Endpoints:

1. Quality of Life (QOL) improvements, including pain, mobility, and emotional well-being, assessed using a validated Wound/Ulcer-QOL tool.
2. Pain levels using a Visual Analog Scale (VAS) at each visit.

Population: Approximately 30 adult subjects (15 per arm) with Wagner Grade 1 diabetic foot ulcers or dehisced wounds will be enrolled. Subjects must have adequate blood flow, demonstrate wound size criteria, and commit to offloading and follow-up care.

Follow-Up: Subjects will be followed weekly through the 12-week study period. Healed subjects will undergo confirmation visits at 2 and 4 weeks post-closure. Subjects in the crossover arm will be followed for an additional 12 weeks if their wound was unhealed at the primary endpoint.

Statistical Considerations: Data will be summarized using descriptive statistics, including wound measurements, infection status, and healing rates. Comparative analysis will be conducted between treatment groups and schedules (weekly vs. biweekly Miro3D application). Adverse events (AEs), serious adverse events (SAEs), and device-related events will also be documented.

This study aims to generate clinical evidence supporting the use of Miro3D as a beneficial adjunct to standard wound care in promoting early and complete healing of diabetic foot ulcers.

Conditions

Diabetic Foot Ulcers (DFUs)

Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer)

Study ID

NCT06939686

Start date

Nov 1, 2024

Status verified date

Dec, 2025

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Must be at least 18 years of age and capable of providing informed consent.
2. 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.
3. Index wound/ulcer must be between 1 cm² and 20 cm² post-debridement.
4. Wound/ulcer must have been present for at least 4 weeks prior to screening.
5. 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.
6. Other wounds, if present, must be at least 2 cm from the index wound/ulcer.
7. Any previous infections must have been adequately treated per IDSA guidelines.
8. Subjects must agree to proper offloading and/or compression, have a stable living environment, and be able to attend follow-up visits.
9. Must provide written consent for digital imaging.
10. For Miro3D arm: Index wound/ulcer must have a clean base free of devitalized tissue or debris at the time of product placement.

Exclusion Criteria:

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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.

active comparator: Standard of Care (SOC) Alone

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.

Interventions

Miro3D Wound Matrix

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.

Standard of Care (SOC)

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.

Primary outcome measure

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

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

  • 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

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.