PolyNovo Limited announced that the first patient has been enrolled in its Randomised Controlled Trial (RCT) evaluating the clinical safety and efficacy of 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 vital cells involved in tissue repair. Chronic wounds advance quickly and, if not treated promptly may necessitate amputation.

The randomised control trial (RCT) on 138 subjects focuses on the use of SynPath to treat chronic diabetic foot ulcers. Given the number of people with Diabetes and the number of DFU patients, recruitment is anticipated to be completed by April 2023. The trial is being conducted over eight sites in the US including The Center for Clinical Research Inc., San Francisco, California and Barry University, Miami, Florida.

The primary efficacy endpoint is to measure the percentage of ulcers fully healed at 12 weeks.