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Clinical Trial Enzyme Application Targeting Venous Leg Ulcers

NCT04956900 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2023-02-15

No results posted yet for this study

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)

Conditions

  • Venous Leg Ulcer
  • Leg Injuries and Disorders

Interventions

DRUG

Aurase Wound gel

Aurase Wound Gel is reconstituted from Aurase Component A (a hydrogel) and Aurase Component B (stabilised solutions of Aurase enzyme). By diluting different strengths of Aurase Component B with Component A, specific concentrations of Aurase Wound Gels with differing Aurase contents are yielded.

Sponsors & Collaborators

  • SolasCure Limited

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-09
Primary Completion
2023-02-06
Completion
2023-02-06
FDA Drug
Yes

Countries

  • United States
  • Hungary
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04956900 on ClinicalTrials.gov