Clinical research study
Skin Temperature Monitoring Reduces the Risk for Diabetic Foot Ulceration in High-risk Patients

https://doi.org/10.1016/j.amjmed.2007.06.028Get rights and content

Abstract

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°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.

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).

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