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

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 weeks postoperatively of a vascular o skin graft procedure.
• •Subject has had prior skin replacement, negative pressure therapy, or traditional ultrasound therapy applied to the index wound in the 14 days prior to screening
• •Subject has had ultrasound treatment (including MIST Therapy) of the index wound.
• •Subject has received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix) within 14 days of screening date.
• •Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
• •Female subjects that are pregnant or refuse to utilize adequate contraceptive methods and are of childbearing age during the trial.
• •Subject has one or more medical condition(s), uncontrolled diabetes (i.e. HbA1c \> 12), renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the investigator would make the subject an inappropriate study candidate
• •Subject's wound would require ultrasound near an electronic implant or prosthesis
• •Subject is known to be suffering from a disorder or other situation that the subject or investigator feels would interfere with compliance or other study requirements
• •Subject is currently enrolled or has been enrolled in the last 30 days in another investigational device or drug trial