Therapeutic Stockings to Prevent Foot Ulcers

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DESCRIPTION (provided by applicant): The objective of this study is to evaluate the effectiveness of therapeutic stockings to reduce the incidence of foot ulcers in high-risk diabetics, and to evaluate self-reported functional status among treatment groups. We expect that subjects treated with therapeutic stockings will have fewer foot ulcers and that their self-reported functional status will be higher than patients receiving standard care. Persons with diabetes with previous foot ulceration have a yearly recurrence rate of more than 30%, even at centers with specialized foot clinics. Therapeutic stockings are an inexpensive and practical mechanism to reduce pressure and shear forces on the foot and thereby reduce the likelihood of ulceration. However, there is very little clinical evidence to support the use of "therapeutic stockings". We will randomize 400 persons with diabetes and a history of foot ulceration to receive standard therapy (ST) consisting of education, regular foot care and protective shoes and insoles; or standard therapy with the addition of therapeutic stockings. The stockings used in this study are designed to reduce pressure and friction at the stocking-foot interface. The NeuroQol instruments will be administered to evaluate self-reported functional status. We will patients at centers in Temple, Texas, Georgetown, Texas, and two centers in Manchester, UK. Patients will be evaluated at least every three months for regular foot care after screening and provision of protective shoes and insoles. Patients will record daily use of therapeutic stockings, insoles and shoes in a log book. Patients will use a step counter to record daily activity. Therapeutic stockings are an inexpensive and practical tool to protect the feet of high risk patients from pressure and shear forces. This simple measure may significantly reduce the risk of foot ulcers in high risk patients.