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.