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.
RCT Entities:
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.
Authors: Bijan Najafi; Hooman Mohseni; Gurtej S Grewal; Talal K Talal; Robert A Menzies; David G Armstrong Journal: J Diabetes Sci Technol Date: 2017-05-17