Clinical Trial Enzyme Application Targeting Venous Leg Ulcers

• Status: Recruiting
• Trial end date: 2022-04-10
• Target enrollment: 0
• Participant gender: All

Summary

This is an 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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SolasCure Limited

Criteria

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 slough and/or eschar 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