AzTrials
AzTrials

Venous Leg UlcerPhase 2CLEANVLUNCT04956900

Clinical Trial Enzyme Application Targeting Venous Leg Ulcers

A Phase 2 study testing Aurase Wound gel in people with Venous Leg Ulcer and Leg Injuries and Disorders, run by SolasCure Limited at 8 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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) Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Leg Ulcer, Leg Injuries and Disorders
What is being tested?
Aurase Wound gel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
8 sitesin 3 countries
Study dates
9 Aug 2021to 6 Feb 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients aged 18 years and older at screening
  • Patients with at least one defined Venous Leg Ulcer (VLU) suitable for treatment that is no smaller than 2cm2 but no larger than 50cm2
  • Presence of devitalised tissue within the reference ulcer suitable for debridement therapy
  • Confirmed, clinically diagnosed VLU (30 days or more) which has been present for less than 2 years
  • Willing and able to attend and comply with study visits and study related activities

Who cannot join

  • Diabetic Foot Ulcer
  • A clinical history of a bleeding disorder including haemophilia, purpura, or thrombocytopenia
  • Current or history of use of anti-thrombotic therapy less than 7 days prior to screening.
  • Stage 4 or 5 chronic kidney disease, defined as estimated glomerular filtration rate (eGFR) less than or equal to 30 mL/min
  • Reference ulcer has active infection or florid oedema at screening
  • Oral or intravenous antibiotics for any indication within 72 hours of screening
Show all 10Show fewer
  • Reference ulcer has exposed tendons, ligaments, muscle, or bone
  • Active osteomyelitis, cellulitis or gangrene in either leg
  • Patients with amputation above a trans metatarsal amputation (TMA) in the target leg
  • Planned vascular surgery, angioplasty, or thrombolysis procedures within the study period, or 4 weeks before screening

Trial locations and contacts

8 sites in 3 countries.

8 sites in 3 countries

United States5 sites

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

  • Doctors Research Network

    Miami, Florida, 33143

  • University of Miami

    Miami, Florida, 33146

  • FASMA

    Salem, Virginia, 24153

  • Center for Clinical Research

    San Francisco, California, 94117

Other trials in United States

Hungary2 sites

  • Óbudai Egészségügyi Centrum Kft.

    Budapest, 1036

  • Uno Medical Trials

    Budapest

Other trials in Hungary

United Kingdom1 site

  • Hull Royal Infirmary

    Hull, HU32JZ

Other trials in United Kingdom

About this study

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.

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)

Read the detailed 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.

Being tested
Aurase Wound gel
Keywords
Wounds, Chronic Leg Ulcer, Leg Ulcer, Venous Leg Ulcer
Medical subject headings
Varicose Ulcer, Leg Injuries, Disease, Wounds and Injuries, Leg Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aurase Wound gelDrug

    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.

Study groups in NCT04956900
Study groupRoleWhat they receive
Aurase wound gel X0ExperimentalCohort 1: Aurase wound gel x0 dose concentration
Receives: Drug: Aurase Wound gel
Aurase wound gel X1ExperimentalCohort 2: Aurase wound gel x1 dose concentration
Receives: Drug: Aurase Wound gel
Aurase wound gel X1.8ExperimentalCohort 3: Aurase wound gel X1.8 dose concentration
Receives: Drug: Aurase Wound gel
Aurase wound gel X5ExperimentalCohort 4: Aurase wound gel X5 dose concentration
Receives: Drug: Aurase Wound gel
Aurase wound gel X9ExperimentalCohort 5: Aurase wound gel X9 dose concentration
Receives: Drug: Aurase Wound gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: From the time of signing informed consent up to the last visit (Day 29)

  2. Change in study wound pain burden from baseline measured by Numerical Rating Scale (NRS)

    Subject will be asked to describe the level of wound pain on a scale of 0-10: 0 being no pain, 10 being worst imaginable pain

    Measured: Pre-dosing and post-dose at day 1 (baseline) through to day 29 (end of study)

  3. Change in study wound itch burden from baseline measured by Numerical Rating Scale (NRS)

    Subject will be asked to describe the level of wound itch on a scale of 0-10: 0 being no itch, 10 being worst imaginable itch

    Measured: Pre-dose at day 1 (baseline) through to day 29 (end of study)

  4. Grading of clinical signs of wound inflammation

    5-point ordinal grading scale (1 [none] to 5 [severe] ) of wound erythema, oedema made by clinical assessor by Visual Assessment (VA)

    Measured: Pre-dosing and Post-dose at day 1 (baseline) through to day 29 (end of study)

  5. Grading of clinical signs of wound infection

    5-point ordinal grading scale (1 [none] to 5 [severe] ) of wound exudate and induration or grading of presence/absence of wound bleeding and infection made by clinical assessor by Visual Assessment (VA)

    Measured: Day 1 (baseline) through to day 29 (end of study)

Secondary outcomes (7)

  1. Change in surface area of wound compared to baseline

    Measured: Day 1 (baseline), day 5, day 12, day 19, day 29 (end of study)

  2. Change in surface area of devitalised tissue (slough, eschar) compared to baseline

    Measured: Day 1 (baseline), day 5, day 12, day 19, day 29 (end of study)

  3. Change in surface area of granulation tissue from baseline

    Measured: Day 1 (baseline) , day 5, day 12, day 19, day 29 (end of study)

  4. Number of patients achieving 100% debridement

    Determination of 100% debridement made by clinical assessor upon assessment of wound at each study visit

    Measured: Day 1 (baseline), day 5, day 12, day 19, day 29 (end of study)

  5. Systemic absorption of Aurase enzyme assessed through pharmacokinetic profiling of blood samples

    Measured: Pre-dose and Post dose at day 1 (baseline) and day 29 (end of study) or early termination visit (if applicable)

  6. Assessment of the presence of antibodies to Aurase in plasma (Anti-Drug Antibody [ADA] activity) through applicable laboratory analysis of blood samples

    Measured: Day 1 (Baseline) and day 29 (end of study) or early termination visit (if applicable)

  7. Assessment of systemic clotting factors in plasma

    Activated partial thromboplastin time (APTT)/ prothrombin time (PT)/Fibrinogen plasma concentrations determined through laboratory analysis of blood samples

    Measured: Day 0 (Screening), day 1 (Baseline), day 8 and day 29 (end of study) or early termination visit (if applicable)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2021
  2. Study start9 Aug 2021
  3. Primary completion6 Feb 2023
  4. Study completion6 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Cohort study design with each cohort having an ascending dose of Aurase wound gel. At the time of initiation, 5 sequential cohorts are planned.
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04956900
Sponsor's protocol ID
SC-VLU-001
Other IDs
2020-001392-32
Acronym
CLEANVLU
Status last verified
Feb 2023
First submitted
25 Jun 2021
Last updated
15 Feb 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aurase Wound gel in people with Venous Leg Ulcer and Leg Injuries and Disorders, run by SolasCure Limited at 8 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Hungary, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From the time of signing informed consent up to the last visit (Day 29)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04956900.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in