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 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.

This clinical study is a prospective, post-market, proof-of-concept trial evaluating the safety and effectiveness of Miro3D Wound Matrix, a biologically derived, acellular scaffold developed by Reprise Biomedical, in the outpatient treatment of complex wounds and ulcerations. Miro3D is made from porcine liver tissue and processed to retain a porous, three-dimensional structure that provides a supportive environment for tissue regeneration.

The study investigates Miro3D's real-world impact on wound healing in adult subjects presenting with chronic or complex wounds, including but not limited to diabetic foot ulcers (DFUs), pressure ulcers, venous leg ulcers (VLUs), and surgical wound dehiscence (SWD). These types of wounds are often difficult to treat, particularly when they exhibit features like tunneling or undermining. The matrix is applied in conjunction with standard of care (SOC) therapies such as cleansing, offloading, compression, debridement, and the use of secondary dressings.

Up to 20 adult participants will be enrolled at outpatient clinical sites under the supervision of a principal investigator. The study includes both a screening phase and a 12-week treatment phase. There is no run-in or washout period. Eligible subjects are identified based on criteria including wound size (1-40 cm²), duration, location, vascular perfusion, and willingness to adhere to follow-up and offloading instructions. Subjects with third-degree burns, active untreated osteomyelitis, malignancy, or known porcine allergy, among other conditions, are excluded.

Each subject will receive Miro3D applied weekly for the first four weeks. If healing has not occurred at that point, Miro3D is reapplied every two weeks for up to twelve weeks or until the wound is fully closed. Wound healing is assessed weekly through manual measurements, photographs, and depth probing. The primary study endpoint is percentage area reduction (PAR) and granulation tissue formation at 4 and 12 weeks.

Secondary endpoints include changes from baseline in patient-reported quality of life (QOL) using the Wound-QOL questionnaire, and pain intensity assessed using a visual analog scale (VAS). These questionnaires are completed weekly to gauge the impact of treatment on physical function, emotional wellbeing, pain, odor, and social engagement. In the event of premature withdrawal, efforts are made to gather final QOL and pain assessments.

Subjects attend weekly study visits and may be seen for additional unscheduled visits at the investigator's discretion (e.g., for dressing changes). If the wound heals before 12 weeks, the subject exits the study. If the wound remains open, the subject exits after the final assessment and may return to their standard treating provider.

The study also closely monitors adverse events (AEs), serious adverse events (SAEs), and unanticipated adverse device effects (UADEs). Investigators assess each event's relationship to the study product and report them to the sponsor and IRB as required. All safety data are collected throughout the study and monitored by the study team and sponsor.

The data collected include subject demographics, medical and surgical history, wound type and size, infection status, tissue characteristics, exudate volume, and treatment regimen. These data are documented in source documents and transcribed into study-specific Case Report Forms (CRFs). Statistical analysis will be performed using summary statistics to evaluate wound closure rates, healing trajectories, and possible correlations between treatment schedule and healing outcomes.

As a post-market study, this trial does not require an Investigational Device Exemption (IDE) and is conducted in compliance with Good Clinical Practice (GCP), the Health Insurance Portability and Accountability Act (HIPAA), and FDA guidelines. It has been approved by an Institutional Review Board (IRB), and informed consent is required from all participants prior to enrollment.

By evaluating Miro3D in real-world outpatient conditions, this study aims to provide evidence on its ability to promote healing in challenging wounds. The findings may help guide future treatment approaches and inform larger clinical trials focused on specific wound types.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 or older and able to provide informed consent.
2. Has an open wound or ulceration, preferably with tunneling or undermining.
3. If multiple wounds/ulcerations are present, only one will be selected for Miro3D treatment.
4. Other wounds must be ≥2 cm away from the study wound.
5. Wound should be debrided with a clinical goal of healing, even if some infection remains.
6. Previous infections must be adequately treated and controlled (per IDSA guidelines).
7. Willing and able to comply with offloading and/or compression requirements.
8. Must have a stable living environment for wound care adherence.
9. Study wound must have a clean base free of devitalized tissue or debris at the time of Miro3D placement.
10. Provides consent for digital photo documentation.

Exclusion Criteria:

1. Active, untreated osteomyelitis.
2. Malignancy or vasculitis at the wound site.
3. Undergoing chemotherapy.
4. On dialysis.
5. Use of investigational drugs or therapies within 30 days before screening.
6. Conditions that significantly impair study adherence or known history of medical non-compliance.
7. Known sensitivity to porcine materials.
8. Third-degree burns.
9. Worsening ischemia or gangrene at screening.
10. Prior radiation to the study wound site.
11. Exposed hardware, implants, or fixation devices in the study wound.
12. Receiving palliative or comfort care.