Venous Insufficiency Leg Ulcer Device

DESCRIPTION (provided by applicant): Between 6 and 7 million people in the United States exhibit some evidence of chronic venous insufficiency and between 600,000 and 700,000 of these individuals have or will develop venous leg ulcers that are associated with recurrent hospitalization, high health care costs, and disability. A large proportion of venous ulcers may be present for 7 - 9 months and many more may be present for greater than 5 years; between 67% - 75% of patients have recurrent problems. Callum, et al in a study of 600 CVI patients found that a third had never healed their first ulcer and two-thirds had a series of ulcers. Consequently, half of the study population had ulcers for more than 10 years and some for virtually their entire adult life. Given the enormous impact on the quality of life, the need for improved prevention and treatment techniques is clear. Compression of the lower extremity is the mainstay of therapy in patients with CVI. Compression techniques have been used in multiple different treatment regimens with modest success. While compression can be effective, it requires strong patient compliance, which is often difficult to obtain. MedEfficiency proposes to develop a new generation compression system - "Slip on Compression (SOC)" - for prevention of CVI wounds. The SOC will be easy for the unassisted patient to put on and take off, will automatically detect and maintain appropriate, consistent, continuous gradient compression, be comfortable and safe, and work synergistically with new wound healing compounds.