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Clinical Trial Enzyme Application Targeting Venous Leg Ulcers — CLEANVLU  

Venous Leg Ulcer Clinical Trial

Official title:
An Open Label, Multiple Ascending Dose Study of the Safety, Tolerability and Bio-effect of Aurase for Wound Debridement in Patients With Venous Leg Ulcers.

Clinical Trial Summary

This is an adaptive 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)

Clinical Trial Description

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, except cohort 1 with 5 patients), 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04956900
Study type Interventional
Source SolasCure Limited
Contact
Status Completed
Phase Phase 2
Start date August 9, 2021
Completion date February 6, 2023
View Details
See also
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