Overview

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