Clinical TriaL Enzyme Application TargetiNg Venous Leg Ulcer CLEANVLU
Research type
Research Study
Full title
An open label, multiple ascending dose study of the safety, tolerability and bio-effect of Aurase for wound debridement in subjects with venous leg ulcers
IRAS ID
287368
Contact name
David Goldsmith
Contact email
Sponsor organisation
SolasCure Ltd
Eudract number
2020-001392-32
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 28 days
Research summary
This is an open-label, first-in-human (Phase IIa) study designed to assess the safety (and efficacy) of Aurase Wound Gel, an enzymatic debridement product, intended for topical application to sloughy venous leg ulcers (VLU). The study has been designed as a dose escalation study, and will serially explore increasing concentrations of the Aurase enzyme in a relevant patient population. Five cohorts of 10 patients each, will receive standard of care supplemented with increasing concentrations of Aurase and will be assessed for clinical tolerability at the wound site, systemic safety and efficacy (extent of wound debridement) over a period of 4 weeks. Patients will receive a total of 12 doses of Aurase Wound Gel. At the end of the study, patients will revert to standard of care only.
REC name
London - City & East Research Ethics Committee
REC reference
20/LO/1300
Date of REC Opinion
6 Jan 2021
REC opinion
Further Information Favourable Opinion