Clinical research studySkin Temperature Monitoring Reduces the Risk for Diabetic Foot Ulceration in High-risk Patients
Section snippets
Methods
In this physician-blinded, 18-month randomized controlled trial, 225 United States veterans with diabetes at high risk for ulceration (neuropathy and deformity or previous history of ulceration) were assigned to standard therapy or dermal thermometry groups. Both groups received therapeutic footwear, diabetic foot education, and regular foot care. All subjects were instructed to perform a structured foot inspection daily and record their findings in a logbook. If Standard Therapy Group subjects
Results
Descriptive characteristics of this population are illustrated in the Table. There was not a significant difference in characteristics based on treatment group assignment (P >.05 for all).
A total of 8.4% (n = 19) of all subjects ulcerated over the 18-month follow-up period. In the Standard Therapy Group, 12.2% (n = 14) of patients ulcerated compared with 4.7% (n = 5) of those in the Dermal Thermometry Group (OR 3.0, CI, 1.0 to 8.5, P = .038).
Proportional hazards regression analysis suggested that
Discussion
There are few effective therapies to help high-risk patients with diabetes prevent foot ulcerations. Under the best circumstances, high-risk patients will receive a few hours of education a year concerning the complications of diabetes, regular foot evaluation by their primary care physician or specialty care by a podiatrist, and protective shoes and insoles. Unfortunately, standard prevention therapies usually are not provided. And, even when patients are treated in centers of excellence with
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This study was supported by VA HSR&D Merit Award 20-059. The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs. All authors had full access to all of the data in the study and all take responsibility for the integrity of the data and the accuracy of the data analysis. This protocol has been registered with Clintrials.gov (NCT00105755).