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Completed

NCT Number: NCT04956900

Clinical Trial Enzyme Application Targeting 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)

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Key information

Conditions

Venous Leg Ulcer Cardiovascular Diseases Disease Leg Injuries Leg Injuries and Disorders Leg Ulcer Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Uno Medical Trials, Budapest, Hungary

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

Aurase Wound gel

Drug

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.

Primary outcomes

  1. 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)

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

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

    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

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

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

    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

  4. Grading of clinical signs of wound inflammation

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

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

  5. Grading of clinical signs of wound infection

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

    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)

Secondary outcomes

  1. Change in surface area of wound compared to baseline

    Time frame: 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

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

  3. Change in surface area of granulation tissue from baseline

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

  4. Number of patients achieving 100% debridement

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

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

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

    Time frame: 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

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

  7. Assessment of systemic clotting factors in plasma

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

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

Sponsors and collaborators

Lead sponsor

SolasCure Limited

Industry

Registry information

Official study 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.

Acronym: CLEANVLU

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 9, 2021
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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