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NCT06939686 · ClinicalTrials.gov registry record · NA
Miro3D Wound Matrix Study for Diabetic Foot Ulcers and Wound Healing
A NA study of Diabetic Foot Ulcers (DFUs) and Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer), sponsored by Reprise Biomedical.
- Recruiting
- Registry status
- NA
- Development phase
- 30
- Enrollment target
- 3
- Study locations
NCT06939686 is a NA study of Diabetic Foot Ulcers (DFUs) and Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer) that is actively recruiting participants, run by Reprise Biomedical. The registered enrollment target is 30 participants. The trial reports 3 study locations across 2 states.
The verdict
NCT06939686, a NA study of Diabetic Foot Ulcers (DFUs) and Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer), is actively recruiting participants, sponsored by Reprise Biomedical.
- RECRUITING
- Registry status
- NA
- Development phase
- 30 participants
- Enrollment target
- 3
- Study locations
Study 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 ad
Conditions Studied
Interventions
- DEVICE Miro3D Wound Matrix
- OTHER Standard of Care (SOC)
Study Locations (3)
Florida
- West Boca Center for Wound Healing - Coconut Creek
- Barry University Clinical Research - Tamarac
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-11-01 |
| Est. Completion | 2026-07-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06939686
The ClinicalTrials.gov registry entry for NCT06939686 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Reprise Biomedical, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Diabetic Foot Ulcers (DFUs) appearing as the primary indexed condition, and to 2 interventions - of which Miro3D Wound Matrix is the first listed.
NCT06939686 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Florida, New York.
Frequently Asked Questions
What is clinical trial NCT06939686 about?
NCT06939686 is a clinical study titled "Miro3D Wound Matrix Study for Diabetic Foot Ulcers and Wound Healing". 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 Rep...
What is the current status of trial NCT06939686?
This trial is currently recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2024-11-01. Estimated completion is 2026-07-31.
What conditions does trial NCT06939686 study?
This clinical trial studies the following conditions: Diabetic Foot Ulcers (DFUs), Chronic Wound of the Lower Limb (Leg Ulcer or Foot Ulcer).
What interventions are being tested in trial NCT06939686?
The interventions under investigation include: Miro3D Wound Matrix (DEVICE), Standard of Care (SOC) (OTHER).
Who is sponsoring clinical trial NCT06939686?
This trial is sponsored by Reprise Biomedical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06939686 being conducted?
This trial has 3 study locations across Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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