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NCT06939673 · ClinicalTrials.gov registry record · NA
Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care
A NA study of Pressure Ulcers and Chronic Wounds, sponsored by Reprise Biomedical.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT06939673 is a NA study of Pressure Ulcers and Chronic Wounds that is actively recruiting participants, run by Reprise Biomedical. The registered enrollment target is 20 participants, below the 230-participant average among 5 other Pressure Ulcers trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT06939673, a NA study of Pressure Ulcers and Chronic Wounds, is actively recruiting participants, sponsored by Reprise Biomedical.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study 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 ti
Conditions Studied
Interventions
- DEVICE Acellular Porcine-Derived Wound Matrix
Study Locations (2)
Florida
- West Boca Center for Wound Healing - Coconut Creek
- Barry University Clinical Research - Tamarac
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-02-29 |
| Est. Completion | 2025-12-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06939673
The ClinicalTrials.gov registry entry for NCT06939673 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 230-participant average among 5 other Pressure Ulcers trials with a reported enrollment target (91% lower). The listed sponsor is Reprise Biomedical, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 6 conditions, with Pressure Ulcers appearing as the primary indexed condition, and to 1 intervention - of which Acellular Porcine-Derived Wound Matrix is the first listed.
NCT06939673 reports 2 study locations spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT06939673 about?
NCT06939673 is a clinical study titled "Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care". 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...
What is the current status of trial NCT06939673?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2024-02-29. Estimated completion is 2025-12-31.
What conditions does trial NCT06939673 study?
This clinical trial studies the following conditions: Pressure Ulcers, Chronic Wounds, Diabetic Foot Ulcers (DFUs), Venous Leg Ulcers (VLUs), Surgical Wound Dehiscence (SWD).
What interventions are being tested in trial NCT06939673?
The interventions under investigation include: Acellular Porcine-Derived Wound Matrix (DEVICE).
Who is sponsoring clinical trial NCT06939673?
This trial is sponsored by Reprise Biomedical, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06939673 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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