Miro3D Wound Matrix Study for Diabetic Foot Ulcers and Wound Healing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorReprise Biomedical, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Miro3D Wound Matrix
DeviceMiro3D 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)
Other interventionSOC 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Miro3D Wound Matrix plus Standard of Care (SOC)Experimental treatment 2 interventions
Group B: Standard of Care (SOC) AloneActive comparator 1 intervention
Trial outcomes
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.
Time frame
4 weeks post-randomizationSecondary outcomes
1
Complete Wound or Ulcer Healing by Week 12
The proportion of subjects whose index wound or ulcer is fully healed (defined as full epithelialization without drainage) at or before week 12. Closure must be sustained for 4 consecutive weeks and confirmed by follow-up visits.
Time frame
Up to 12 weeks post-randomization2
Quality of Life (QOL) Assessment Using Wound-QOL Instrument
Change from baseline in subject-reported quality of life using the Wound-QOL tool, which assesses domains such as pain, odor, physical function, mobility, depression, and social isolation.
Time frame
Baseline, Week 4, Week 8, and Week 12 or at early termination3
Pain Score Assessment Using Visual Analog Scale (VAS)
Change from baseline in pain intensity as measured by a standard 0-10 Visual Analog Scale (VAS), where 0 represents no pain and 10 represents worst possible pain.
Time frame
Collected at every study visit (weekly through week 12)Other outcomes
1
Healing Trajectory at Weeks 6 and 8
Interim assessments of percent area reduction (PAR) and granulation at weeks 6 and 8 to evaluate healing trajectory and likelihood of closure by week 12.
Time frame
6 weeks and 8 weeks post-randomization2
Safety Profile: Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Device Effects (UADEs)
Collection and evaluation of all adverse events, serious adverse events, and unanticipated adverse device effects. Events will be assessed for severity, expectedness, and relationship to the study device or SOC.
Time frame
From informed consent through 30 days post-final study visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Reprise Biomedical, Inc.
Lead sponsor
Barry University
Collaborator
Icahn School of Medicine at Mount Sinai
Collaborator
Source ClinicalTrials.gov