Pilot Parallel Group RCT to assess debridement safety and efficacy of Aurase Wound Gel 24U/mL in VLU
Research type
Research Study
Full title
A pilot, randomised, parallel group, study to assess the debridement safety and efficacy of Aurase Wound Gel (AWG) 24 U/mL compared to Standard of Care in patients with sloughy Venous Leg Ulcers
IRAS ID
1010587
Contact name
David Fairlamb
Contact email
Sponsor organisation
SolasCure Ltd
ISRCTN Number
ISRCTN59816814
Research summary
As a pre-cursor to larger Phase II clinical trials, this pilot clinical trial seeks to build on the results of the initial [First-in human] Phase IIA clinical trial, utilising RCT controls. Specifically, this pilot clinical trial seeks to further assess the local safety profile of topically applied Aurase Wound Gel (24 U/mL) over 9 applications [3 weeks] (primary endpoint) and to explore its efficacy in debriding [removing slough and eschar from the wound] and wound healing rate (secondary endpoints) in a Venous Leg Ulcer patient population. After a 2-week screening period utilising standard of care dressings + compression bandaging [designed to exclude patients that would otherwise readily heal], participants with stalled, sloughy VLU wounds will be randomised to treatment with Aurase Wound Gel or UK standard of care (hydrogel) + standard of care dressings + compression bandaging three times weekly for three weeks. At the end of the treatment period, participants will be followed up for a further 1 week. This study has been designed to be run in a GP community clinic which is more representative of the standard treatment pathway for Venous Leg Ulcers in the UK and to assess the potential for Aurase Wound Gel as a treatment for VLU wounds.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
24/SW/0127
Date of REC Opinion
18 Nov 2024
REC opinion
Further Information Favourable Opinion