← Back to Search

Enzymatic Debridement Product

Aurase Wound gel for Venous Leg Ulcer (CLEANVLU Trial)

Phase 2
Waitlist Available
Research Sponsored by SolasCure Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (baseline), day 5, day 12, day 19, day 29 (end of study)
Awards & highlights

CLEANVLU Trial Summary

This trial will test a new gel intended to heal sloughy venous leg ulcers. The gel will be applied to the ulcers, and safety and efficacy will be assessed.

Eligible Conditions
  • Venous Leg Ulcer
  • Leg Injuries and Disorders

CLEANVLU Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (baseline), day 5, day 12, day 19, day 29 (end of study)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (baseline), day 5, day 12, day 19, day 29 (end of study) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in study wound itch burden from baseline measured by Numerical Rating Scale (NRS)
Viral Load result
Wound Infection
+2 more
Secondary outcome measures
Assessment of systemic clotting factors in plasma
Assessment of the presence of antibodies to Aurase in plasma (Anti-Drug Antibody [ADA] activity) through applicable laboratory analysis of blood samples
Change in surface area of devitalised tissue (slough, eschar) compared to baseline
+4 more

CLEANVLU Trial Design

5Treatment groups
Experimental Treatment
Group I: Aurase wound gel X9Experimental Treatment1 Intervention
Cohort 5: Aurase wound gel X9 dose concentration
Group II: Aurase wound gel X5Experimental Treatment1 Intervention
Cohort 4: Aurase wound gel X5 dose concentration
Group III: Aurase wound gel X1.8Experimental Treatment1 Intervention
Cohort 3: Aurase wound gel X1.8 dose concentration
Group IV: Aurase wound gel X1Experimental Treatment1 Intervention
Cohort 2: Aurase wound gel x1 dose concentration
Group V: Aurase wound gel X0Experimental Treatment1 Intervention
Cohort 1: Aurase wound gel x0 dose concentration
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aurase Wound gel
2021
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

SolasCure LimitedLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Aurase Wound gel met the standards for FDA authorization?

"Based on the Phase 2 trial data, our team at Power estimated that Aurase Wound gel is relatively safe and scored it a two. Though there are safety results available, efficacy has yet to be verified through clinical trials."

Answered by AI

Are there a plethora of sites running this clinical research in Canada?

"This trial is ongoing in 5 locations, including the Center for Clinical Research in San Francisco, Mayo Clinic Jacksonville in Florida, and Doctors Research Network South Beach. Additionally there are 2 more sites offering this medication to their patients."

Answered by AI

Is this experimental research pioneering in its field?

"Since 2021, the effectiveness of Aurase Wound gel has been studied. The initial trial was sponsored by SolasCure Limited and involved 45 participants that warranted Phase 2 drug approval. Currently, two trials are running across multiple cities in 3 countries."

Answered by AI

How many individuals are currently engaged in the experiment?

"Affirmative. Records from clinicaltrials.gov demonstrate that this research, first posted on August 9th 2021, is actively recruiting for enrolment. 45 participants are needed at 5 separate medical centres."

Answered by AI

What ailments is Aurase Wound gel typically prescribed for?

"Aurase Wound gel is capable of treating a variety of skin issues, from cosmetic blemishes to serious dental infections and scarring."

Answered by AI

Can you provide a synopsis of the existing research surrounding Aurase Wound gel?

"Aurase Wound Gel was initially tested at Hull Royal Infirmary in 2021, and there are currently four completed trials. At the moment, two further studies are accepting participants out of San Francisco, California."

Answered by AI

Are there any vacancies available for prospective participants in this experiment?

"According to clinicaltrials.gov, this medical experiment is actively finding participants. It was initially made public on August 9th 2021 and has been modified as recently as July 25 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Clinical Trial Enzyme Application Targeting Venous Leg Ulcers
2021. "Clinical Trial Enzyme Application Targeting Venous Leg Ulcers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04956900.
~12 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top