REDUCTION OF LOWER-EXTREMITY CLINICAL ABNORMALITIES IN PATIENTS WITH NONINSULIN-DEPENDENT DIABETES-MELLITUS - A RANDOMIZED, CONTROLLED TRIAL

Objective: To evaluate the effect of a patient. health care provider, and systems intervention on the prevalence of risk factors for lower e xtremity amputation in patients with non-insulin-dependent diabetes. D esign: Blinded, randomized, controlled trial. Setting: Academic genera l medicine practice. Participants: Of the 395 patients with non-insuli n-dependent diabetes who underwent the initial patient assessment, 352 completed the study. Intervention: The 12-month intervention was mult i-faceted. Patients received foot-care education and entered into a be havioral contract for desired self-foot care, which was reinforced thr ough telephone and postcard reminders. Health care providers were give n practice guidelines and informational flow sheets on foot-related ri sk factors for amputation in diabetic patients. In addition, the folde rs for intervention patients had special identifiers that prompted hea lth care providers to 1) ask that patients remove their footwear, 2) p erform foot examinations, and 3) provide foot-care education. Results: Patients receiving the intervention were less likely than control pat ients to have serious foot lesions (baseline prevalence, 2.9%; odds ra tio, 0.41 (95% Cl, 0. 1 6 to 1.001; P = 0.05) and other dermatologic a bnormalities. Also, they were more likely to report appropriate self-f oot-care behaviors, to have foot examinations during office visits (68 % compared with 28%; P < 0.001), and to receive foot-care education fr om health care providers (42% compared with 18%; P < 0.001). Physician s assigned to intervention patients were more likely than physicians a ssigned to control patients to examine patients' feet for ulcers, puls es, and abnormal dermatologic conditions and to refer patients to the podiatry clinic (10.6% compared with 5.0%; P = 0.04). Conclusions: An intervention designed to reduce risk factors for lower extremity amput ations positively affected patient self-foot-care behavior as well as the foot care given by health care providers and reduced the prevalenc e of lower extremity clinical disease in patients with diabetes.