First clinical evaluation of the safety and efficacy of tarumase for the debridement of venous leg ulcers.

"CONFLICT OF INTEREST STATEMENT David Fairlamb, Kinga Szepeshazi and David Goldsmith are employees and shareholders of SolasCure Ltd."

"FUNDING INFORMATION Funding for all reported studies was provided by SolasCure Ltd, Wellington House, East Road, Cambridge, CB1 1BH, UK."

"The clinical study (Clinicaltrials.gov registration NCT04956900; EudraCT 2020‐001392‐32) was a prospective, open‐label, multi‐centre, dose escalation study that was conducted in accordance with the requirements of the International Council on Harmonisation Good Clinical Practice (ICH GCP) and in accordance with national regulations and guidance of the United Kingdom, Hungary and United States. It was conducted across a total of 8 clinical centres, with the primary objective of establishing systemic safety (adverse events, pharmacokinetics, anti‐drug antibodies) and local tolerability of a topically applied (tarumase containing) hydrogel (Aurase Wound Gel, SolasCure Ltd), dosed 2–3 times weekly over a 4‐week period (12 doses) to a clinically relevant patient population of sloughy VLUs. Secondary objectives included the exploration of effects on rate and/or extent of wound debridement and wound healing trajectory."