Clinical Trial Enzyme Application Targeting Venous Leg Ulcers (CLEANVLU)

SolasCure

Status and phase: Completed; Phase 2

Conditions: Venous Leg Ulcer; Leg Injuries and Disorders

Treatments: Drug: Aurase Wound gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT04956900

SC-VLU-001

2020-001392-32 (EudraCT Number)

Details and patient eligibility

About

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)

Full 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.

Enrollment: 43 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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43 participants in 5 patient groups

Aurase wound gel X0

Experimental group

Description:

Cohort 1: Aurase wound gel x0 dose concentration

Treatment:

Drug: Aurase Wound gel

Aurase wound gel X1

Experimental group

Description:

Cohort 2: Aurase wound gel x1 dose concentration

Treatment:

Drug: Aurase Wound gel

Aurase wound gel X1.8

Experimental group

Description:

Cohort 3: Aurase wound gel X1.8 dose concentration

Treatment:

Drug: Aurase Wound gel

Aurase wound gel X5

Experimental group

Description:

Cohort 4: Aurase wound gel X5 dose concentration

Treatment:

Drug: Aurase Wound gel

Aurase wound gel X9

Experimental group

Description:

Cohort 5: Aurase wound gel X9 dose concentration

Treatment:

Drug: Aurase Wound gel