Evaluation of the Effect of the Flowaid Device in Increasing Local Circulation in the Leg

Inclusion Criteria:

• Give appropriate written informed consent prior to participation in the study
• Have a current diagnosis of Type I or Type II Diabetes Mellitus
• Have an Ankle-Arm Index between 0.35 and 0.8 on the study limb
• Be in reasonable metabolic control, exhibited by HbA1C values of less than12% as observed by serum test results obtained within 3 months prior to the Screening Visit
• Subject and caregiver must be accessible for, and willing to comply with, the safety procedures and available for the 12 week Follow-Up Period

Exclusion Criteria:

• Clinical evidence of gangrene on any part of affected foot
• Active Charcot's foot on the study limb
• Scheduled to undergo vascular surgery, angioplasty, or thrombolysis within 30 days from the end of the study
• Malnourished as evidenced by a pre-albumin of < 11 mg/dL
• Pregnancy or lactating
• History of bleeding disorder
• Participation in another device study for the treatment of Peripheral Vascular Disease 30 days prior to Screening Visit
• Vascular procedures performed 30 days prior to Screening Visit