Anodyne Therapy in Diabetic Sensory Neuropathy

Inclusion Criteria: Subjects with diabetes mellitus and peripheral sensory neuropathy. Subjects at least 25 years old. Vibration perception threshold (VPT) ≥ 20 volts and ≤ 45 volts. Subjects must be alert, oriented, mentally competent and able to understand and comply with the requirements of the study, and provide voluntary informed consent. Subjects must be willing and able to complete the required study visits and record treatment activity in the study logbook. Exclusion Criteria: Subjects who have a VPT <20 or > 45 volts. Subjects with uncontrolled hypertension greater than 180 systolic or greater than 110 diastolic as determined by enrollment questionnaire Subjects who are pregnant or breastfeeding or who are likely to become pregnant during the course of the study. Subjects with active malignancy (including basal cell carcinoma) on the lower extremities. Subjects who have had prior reconstructive or replacement knee surgery with neurological deficits related to the surgery. ( If the patient has had knee surgery, their neuropathy appears to be uniform and bilateral, then they can be included in the study). Subjects with a history of previous back surgery, spinal stenosis, or spinal compression or radiculopathy with neurological deficits related to spinal cord pathology. ( If the patient has had back surgery, their neuropathy appears to be uniform and bilateral, then they can be included in the study). Subjects who are non-ambulatory. Subjects with a history of neuromuscular disease, leprosy, chronic alcoholism, or sarcoidosis. Subjects with foot ulcerations. Subjects with a transmetatarsal amputation or higher