An Evaluation of an SCCD on the Symptomatology of Painful DPN

Inclusion Criteria: * Have a current diagnosis of Type I or Type II Diabetes Mellitus * Have a documented diagnosis of Diabetic Peripheral Neuropathy by either their Primary Care Physician or other physician treating their condition made no less than 6 months prior to initiation of the study. * Have been on stable pain medications (no change to type, dose or frequency) for at least 1 month prior to their entry into the study.Give appropriate written informed consent prior to participation in the study * Be between 18 and 90 years of age, inclusive, on the day the Informed Consent Form is signed * Have an average baseline VAS score of 4 or more as assessed during the week just prior to randomization * Be in reasonable metabolic control, exhibited by HbA1C values of less than 12% as observed by serum test results obtained within 3 months prior to the Screening Visit * Be willing to remain on the same pain medication regimen for the duration of the study * If subject is of childbearing potential, she must be using an acceptable method of birth control. Women not of childbearing potential are defined as either surgically sterile or post-menopausal. Post-menopausal women are defined as those women with a documented menstruation cessation for 12 consecutive months prior to signing the Informed Consent Form. * Subject and caregiver, if applicable, must be accessible and willing to comply with all requirements of the study protocol for the duration of the study. Exclusion Criteria: * Clinical evidence of compromised skin (e.g., wound, infection, gangrene) on the lower legs * Active Charcot's foot on either limb * Malnourished as evidenced by a pre-albumin of \< 11 mg/dL * Pregnancy or lactating * Known history of alcohol or drug abuse within the previous one year * Previous treatment with SCCD * Elective osseous procedures performed to either foot 30 days prior to Screening visit * Vascular procedures performed 30 days prior to Screening Visit * History of poor compliance to medical treatment regimens * Conditions that may severely compromise their ability to complete the study. * Concomitant history of Peripheral Arterial disease with an ABI of \<0.5 * Chronic pain due to an etiology other than diabetic neuropathy