Clinical Trial Enzyme Application Targeting Venous Leg Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-09

Study Completion Date

2023-02-06

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Venous Leg Ulcer Leg Injuries and Disorders

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Cohort study design with each cohort having an ascending dose of Aurase wound gel. At the time of initiation, 5 sequential cohorts are planned.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aurase wound gel X0

Cohort 1: Aurase wound gel x0 dose concentration

Group Type EXPERIMENTAL