Preliminary Assessment of the Efficacy of the VascuActive™ Device on Diabetic Peripheral Neuropathy

Inclusion Criteria: * Diabetes Mellitus (type 1 or 2) * Age 18 years or older * No changes within the last 3 months in diabetes medications, pain management medications, and symptoms associated with diabetes * Painful diabetic neuropathy \> 3 months, but not more than 5 years * Pain level ≥ 4 on an 11 point Numerical Pain Rating Scale in both feet (average of two measurements, at least 1 week apart, during the 2 weeks prior to first treatment) * Loss of protective sensation by the 5.07 Semmes-Weinstein Monofilament (SWM, 10gr.) monofilament test (in both feet, at least at 3 out of 10 points in each foot) Exclusion Criteria: * Known or suspected radiculopathy (based on patient's record and anamnesis) * Any painful condition that is difficult to distinguish from painful diabetic peripheral neuropathy * Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive * Severe cardiac disease or surgery within last 3 months, e.g., Acute Myocardial Infarction, Congestive Heart Failure grade 3 or higher * Any major infectious, malignant or other severe systemic disease, including but not limited to Acquired Immune Deficiency Syndrome (AIDS), hepatitis, Creutzfeldt-Jakob disease * Patient is incompetent to comply with study requirements (in the investigator's opinion)