PolyNovo (ASX:PNV) has announced that the first patient has been enrolled in its trial evaluating the clinical safety and efficacy of its NovoSorb SynPath for the treatment of chronic diabetic foot ulcers (DFU’s).
SynPath is designed to promote organised healing by providing a porous network of biodegradable synthetic polymers which act as a template to support the proliferation of cells involved in tissue repair. Chronic wounds advance quickly and, if not treated promptly may necessitate amputation.
The trial will involve 138 subjects and focus on the use of SynPath to treat chronic diabetic foot ulcers. Recruitment is anticipated to be completed by April 2023. The trial is being conducted over eight sites in the US.
The company said the primary efficacy endpoint is to measure the percentage of ulcers fully healed at 12 weeks.
According to CEO Swami Raote, "We are thrilled to have initiated our trial utilising NovoSorb SynPath for the treatment of chronic diabetic foot ulcers. This critical milestone has us on the road to help more patients with non-healing chronic wounds and to further investigate the benefits of our novel technology for these wound types. SynPath is leveraging our successes in the acute care setting with NovoSorb BTM and allows us to expand our offering to the outpatient setting for clinicians dedicated to changing the lives of their patients.”
Chairman,David Williams added, “Many surgeons are already successfully using BTM for the treatment of DFUs, but the time has come for a specific product to treat DFUs and venous leg ulcers. The trial will provide valuable data for surgeons and importantly, also put us on the path to reimbursement.”