Clinical Trial Enzyme Application Targeting Venous Leg Ulcers
- Conditions
- Venous Leg UlcerLeg Injuries and Disorders
- Interventions
- Drug: Aurase Wound gel
- Registration Number
- NCT04956900
- Lead Sponsor
- SolasCure Limited
- Brief 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)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Aurase wound gel X1 Aurase Wound gel Cohort 2: Aurase wound gel x1 dose concentration Aurase wound gel X9 Aurase Wound gel Cohort 5: Aurase wound gel X9 dose concentration Aurase wound gel X0 Aurase Wound gel Cohort 1: Aurase wound gel x0 dose concentration Aurase wound gel X1.8 Aurase Wound gel Cohort 3: Aurase wound gel X1.8 dose concentration Aurase wound gel X5 Aurase Wound gel Cohort 4: Aurase wound gel X5 dose concentration
- Primary Outcome Measures
Name Time Method Grading of clinical signs of wound inflammation 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)
Incidence of treatment emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) From the time of signing informed consent up to the last visit (Day 29) Change in study wound itch burden from baseline measured by Numerical Rating Scale (NRS) 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
Change in study wound pain burden from baseline measured by Numerical Rating Scale (NRS) 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
Grading of clinical signs of wound infection 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 Outcome Measures
Name Time Method Change in surface area of granulation tissue from baseline Day 1 (baseline) , day 5, day 12, day 19, day 29 (end of study) Change in surface area of devitalised tissue (slough, eschar) compared to baseline Day 1 (baseline), day 5, day 12, day 19, day 29 (end of study) Change in surface area of wound compared to baseline Day 1 (baseline), day 5, day 12, day 19, day 29 (end of study) Assessment of systemic clotting factors in plasma 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
Number of patients achieving 100% debridement 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
Systemic absorption of Aurase enzyme assessed through pharmacokinetic profiling of blood samples Pre-dose and Post dose at day 1 (baseline) and day 29 (end of study) or early termination visit (if applicable) Assessment of the presence of antibodies to Aurase in plasma (Anti-Drug Antibody [ADA] activity) through applicable laboratory analysis of blood samples Day 1 (Baseline) and day 29 (end of study) or early termination visit (if applicable)
Trial Locations
- Locations (8)
Center for Clinical Research
🇺🇸San Francisco, California, United States
FASMA
🇺🇸Salem, Virginia, United States
Hull Royal Infirmary
🇬🇧Hull, United Kingdom
Doctors Research Network
🇺🇸Miami, Florida, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
University of Miami
🇺🇸Miami, Florida, United States
Óbudai Egészségügyi Centrum Kft.
🇭🇺Budapest, Hungary
Uno Medical Trials
🇭🇺Budapest, Hungary