New Zealand-based soft tissue repair specialist Aroa Biosurgery Limited announced on Sunday completion of its randomised controlled trial (RCT) evaluating Symphony in patients with diabetic foot ulcers, with a preliminary read-out indicating that the primary endpoint was met.

Symphony is AROA's Cellular, Acellular and Matrix-like Product (CAMP), or skin substitute, designed for the treatment of hard-to-heal wounds, including diabetic foot ulcers and venous leg ulcers. The product combines multiple layers of AROA ECM with high molecular weight hyaluronic acid.

The prospective, multi-centre, randomised trial evaluated the safety and performance of Symphony in the treatment of chronic Wagner grade 1 and 2 non-healing diabetic foot ulcers. Patients were randomised to receive either Symphony or standard of care (SOC) dressings on a weekly basis until wound healing or for up to 12 weeks.

The study design provided for recruitment of up to 150 patients across multiple sites in the United States. The primary endpoint assessed whether more diabetic foot ulcers healed within the 12-week treatment period with Symphony compared with SOC.

Based on the preliminary read-out, AROA believes the trial met its primary endpoint. The company expects that, once confirmed through final analysis and publication, the results will further support Symphony's clinical efficacy in the management of diabetic foot ulcers.

AROA added that it believes publication of the full study results will help meet the high standard of clinical evidence likely to be required under future reimbursement policies.