Clinical Trial Enzyme Application Targeting Venous Leg Ulcers

Venous Leg Ulcer Clinical Trial

— CLEANVLU  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04956900
• Other study ID #: SC-VLU-001
• Secondary ID: 2020-001392-32
• Status: Completed
• Phase: Phase 2
• Start date: August 9, 2021
• Est. completion date: February 6, 2023

Study information

• Verified date: February 2023
• Source: SolasCure Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

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 information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 6, 2023
• Est. primary completion date: February 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leg Injuries
• Leg Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

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.

Locations

Country	Name	City	State
Hungary	Óbudai Egészségügyi Centrum Kft.	Budapest
Hungary	Uno Medical Trials	Budapest
United Kingdom	Hull Royal Infirmary	Hull
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	Doctors Research Network	Miami	Florida
United States	University of Miami	Miami	Florida
United States	FASMA	Salem	Virginia
United States	Center for Clinical Research	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
SolasCure Limited

Countries where clinical trial is conducted

United States,  Hungary,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Pre-dosing and post-dose at day 1 (baseline) through to day 29 (end of study)
Primary	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	Pre-dose at day 1 (baseline) through to day 29 (end of study)
Primary	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)	Pre-dosing and Post-dose at day 1 (baseline) through to day 29 (end of study)
Primary	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)	Day 1 (baseline) through to day 29 (end of study)
Secondary	Change in surface area of wound compared to baseline		Day 1 (baseline), day 5, day 12, day 19, day 29 (end of study)
Secondary	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)
Secondary	Change in surface area of granulation tissue from baseline		Day 1 (baseline) , day 5, day 12, day 19, day 29 (end of study)
Secondary	Number of patients achieving 100% debridement	Determination of 100% debridement made by clinical assessor upon assessment of wound at each study visit	Day 1 (baseline), day 5, day 12, day 19, day 29 (end of study)
Secondary	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)
Secondary	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)
Secondary	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	Day 0 (Screening), day 1 (Baseline), day 8 and day 29 (end of study) or early termination visit (if applicable)