Clinical Trial Enzyme Application Targeting Venous Leg Ulcers
Completed · Phase 2
Conditions studied: Venous Leg Ulcer, Leg Injuries and Disorders
In brief
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)
Key facts
- Study ID
- NCT04956900
- Run by
- SolasCure Limited
- People needed
- 43
- Starts
- 2021-08-09
- Expected to finish
- 2023-02-06
- Last updated by the study team
- 2023-02-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Center for Clinical Research — San Francisco, California, 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
- Óbudai Egészségügyi Centrum Kft. — Budapest, Hungary
- Uno Medical Trials — Budapest, Hungary
- Hull Royal Infirmary — Hull, United Kingdom
Full record on ClinicalTrials.gov
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