An Evaluation of an SCCD on the Symptomatology of Painful DPN

This is a controlled trial of 30 days duration to evaluate the efficacy of an Sequential
Contraction Compression Device (SCCD) on the symptomatology of Painful Diabetic Neuropathy.
Subjects will have to have been on a sustained drug regimen for more than 30 days and have an
average pain level of 4 on a VAS. Subjects will be divided into a control group where they
will be monitored while continuing with their current treatment regimen and into a treatment
group where they will continue with their current regimen and have SCCD therapy added.
Patients will be asked to use the SCCD device daily on both their legs. Subjects will be
evaluated for Subjective Pain levels using a Visual Analog Scale, quality of life using
various questionnaires, breakthrough drug use in a daily log, sleep levels i.e. how many
consecutive hours of sleep, and objectively with a Quantitative Sensory Testing device.

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