A Clinical Study of Reprise Biomedical's Miro3D Wound Matrix in the Outpatient Management of Wounds and Ulcerations

What this Trial Is About

Researchers are evaluating the Miro3D Wound Matrix, a biologic wound dressing made from pig liver tissue, to help heal difficult wounds and ulcers in adults. This post-market, proof-of-concept study focuses on wounds such as diabetic foot ulcers, venous leg ulcers, pressure ulcers, and surgical wound openings. The study aims to understand how well Miro3D supports healing and improves quality of life when used alongside standard wound care in outpatient settings. Participants will receive weekly applications of Miro3D to their wounds for the first four weeks, alongside usual treatments like cleaning, dressing changes, offloading, and infection management. If the wound is not fully healed after four weeks, the Miro3D application frequency changes to every two weeks until healing occurs or up to twelve weeks total. The study includes a screening phase and a twelve-week treatment phase with no washout period. Throughout the study, participants will visit the clinic weekly for wound assessments, including measurements, photographs, and depth checks, and complete questionnaires about pain and quality of life. Healing progress is tracked by measuring wound size reduction and new tissue growth. Safety is closely monitored by tracking any adverse events. Participants finish the study when their wound heals or after twelve weeks and may then return to their regular doctor for follow-up care.

Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care