Skin temperature monitoring reduces the risk for diabetic foot ulceration in high-risk patients

PURPOSE: To evaluate the effectiveness of home temperature monitoring to reduce the incidence of foot ulcers in high-risk patients with diabetes. METHODS: In this physician-blinded, 18-month randomized controlled trial, 225 subjects with diabetes at high risk for ulceration were assigned to standard therapy ( Standard Therapy Group) or dermal thermometry (Dermal Thermometry Group) groups. Both groups received therapeutic footwear, diabetic foot education, regular foot care, and performed a structured foot inspection daily. Dermal Thermometry Group subjects used an infrared skin thermometer to measure temperatures on 6 foot sites twice daily. Temperature differences > 4 degrees F between left and right corresponding sites triggered patients to contact the study nurse and reduce activity until temperatures normalized. RESULTS: A total of 8.4% (n = 19) subjects ulcerated over the study period. Subjects were one third as likely to ulcerate in the Dermal Thermometry Group compared with the Standard Therapy Group (12.2% vs 4.7%, odds ratio 3.0, 95% confidence interval, 1.0 to 8.5, P=.038). Proportional hazards regression analysis suggested that thermometry intervention was associated with a significantly longer time to ulceration (P=.04), adjusted for elevated foot ulcer classification ( International Working Group Risk Factor 3), age, and minority status. Patients that ulcerated had a temperature difference that was 4.8 times greater at the site of ulceration in the week before ulceration than did a random 7 consecutive-day sample of 50 other subjects that did not ulcerate (3.50 +/- 1.0 vs 0.74 +/- 0.05, P=.001). CONCLUSIONS: High temperature gradients between feet may predict the onset of neuropathic ulceration and self-monitoring may reduce the risk of ulceration. (c) 2007 Elsevier Inc. All rights reserved.