MIST Ultrasound Therapy Compared to United Kingdom Standard Care for the Treatment of Non-healing Venous Leg Ulcers

Inclusion Criteria: * Venous leg ulcers (as diagnosed by the clinician) * Ankle Brachial Pressure Index (ABPI) \>0.8 * If multiple ulcers are present treat largest ulcer only (index ulcer) with minimum distance of 1 cm between index ulcer and any other ulcer * 18 years or older * Ulcer size of 5 cm\^2 - 100 cm\^2 (with no longest length being greater than 10 cm) at randomisation point (week 5) * Mobile enough to attend clinic * Index ulcer between 6 weeks and 5 years duration prior to screening date Exclusion Criteria: * Uncontrolled diabetes (Hba1c ≥12%) as tested within the past 3 months * Index ulcer has active infection on day of inclusion requiring use or oral or IV antibiotics * Renal failure * Index ulcer has exposed tendons, ligaments, muscle, or bone * Osteomyelitis or cellulitis or gangrene in study limb * Subjects with amputation above a trans metatarsal amputation (TMA) in the study limb * Subjects with active malignancy on the study limb * Index ulcer that is of arterial disease aetiology * Females of child bearing potential who are not willing to use a method of highly effective contraception during the entire study * Planned vascular surgery, angioplasty, or thrombolysis procedures within the study period, or 6 weeks post-operatively * Planned surgical procedure during the study period for the index wound * Prior skin replacement, negative pressure therapy, ultrasound therapy applied to the index wound 2 weeks before screening * Oral or IV antibiotics within…