Principal Investigator
Enrollment Status
Clinical Trial ID
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)
Phase
Phase 2
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment 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