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 time. If the wound does not heal, the participant may return to their regular physician for follow-up care.
Age 18 or older and able to provide informed consent.
Has an open wound or ulceration, preferably with tunneling or undermining.
If multiple wounds/ulcerations are present, only one will be selected for Miro3D treatment.
Other wounds must be ≥2 cm away from the study wound.
Active, untreated osteomyelitis.
Malignancy or vasculitis at the wound site.
Undergoing chemotherapy.
On dialysis.
Single group
Acellular Porcine-Derived Wound Matrix
DeviceThis intervention is a sterile, acellular, three-dimensional biologic scaffold derived from porcine liver tissue using a proprietary perfusion decellularization and drying process. It retains the native extracellular matrix structure and supports tissue granulation and healing in complex wounds. Miro3D is applied topically to the debrided wound bed and rehydrated prior to use. It is indicated for use in a range of chronic and complex wounds, including diabetic foot ulcers, venous leg ulcers, pressure injuries, and surgical dehiscence. In this study, it is administered in an outpatient setting alongside standard of care treatments.
Percent Area Reduction (PAR) and Granulation Tissue Formation at 4 and 12 Weeks
The primary outcome is the measurement of the wound or ulcer's percent area reduction (PAR) and granulation tissue formation at week 4 and week 12. This is used to evaluate healing progression and the effectiveness of Miro3D. Measurements are taken using a ruler for length and width, and a probe for depth. Granulation is assessed visually by the clinical team.
Change in Quality of Life (QOL) Using Wound-QOL Instrument
Subject-reported QOL will be assessed at each visit using the Wound-QOL questionnaire. This tool evaluates the impact of the wound on domains such as pain, odor, physical functioning, mobility, emotional wellbeing, and social isolation.
Change in Pain Levels Using Visual Analog Scale (VAS)
Pain intensity is assessed weekly using a 0-10 VAS, where 0 represents no pain and 10 represents the worst possible pain.
Safety and Tolerability: Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Device Effects (UADEs)
The frequency and severity of adverse events, including product-related effects such as inflammation, irritation, or infection, will be recorded. Events will be assessed for seriousness, expectedness, and relatedness to the investigational product.
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