Miro3D Wound Matrix Study for Diabetic Foot Ulcers and Wound Healing

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)

Interventions

DEVICE

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.

OTHER

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.

Sponsors & Collaborators

• Barry University

  collaborator OTHER

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• Reprise Biomedical, Inc.

  lead INDUSTRY

Principal Investigators

• Robert J. Snyder, DPM · Barry University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-11-01

Primary Completion

2026-07-31

Completion

2026-07-31

FDA Device

Yes

Countries

• United States

Study Locations