Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers

Inclusion Criteria: * Lower extremity full thickness venous ulcer of \> 30 days duration * Subject's wound must be between 4 cm² and 50 cm² at screening * Documented ABI that is between 0.8 and 1.2 on the study limb or transcutaneous partial pressure oxygen (TcpO2) \> 40 mmHG; or a toe pressure \> 40 mmHG; or a Doppler waveform consistent with adequate flow in the foot (biphasic or triphasic waveforms) at time of screening * Biopsy for wounds \> 6 months duration * Documented index wound etiology of venous stasis with reflux and /or incompetent valves Exclusion Criteria: * Index ulcer wound that is less than 1 cm in distance from another ulcer wound * \> 5 ulcers on the index leg * Index ulcer wound has exposed tendons, ligaments, muscle, or bone * Index ulcer wound presents with clinical signs of acute infection, suspected or known * Subjects with evidence of osteomyelitis or cellulitis or gangrene in the study limb * Subjects with amputation above a Trans Metatarsal Amputation (TMA) in the study limb * Subjects with active malignancy on the study limb except non-melanoma skin cancer * Index ulcer that is of arterial disease etiology * Index ulcer of other primary etiology (ie. vasculitis, arterial, pyoderma) * Subjects with planned vascular surgery, angioplasty or thrombolysis procedures within the study treatment phase * Subjects with planned surgical procedure during the study treatment phase for the index wound including skin flap or skin graft * Subjects within 6 wee…