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Abstract
Objective Daily remote foot temperature monitoring is an evidence-based preventive practice for patients at risk for diabetic foot complications. Unfortunately, the conventional approach requires comparison of temperatures between contralaterally matched anatomy, limiting practice in high-risk cohorts such as patients with a wound to one foot and those with proximal lower extremity amputation (LEA). We developed and assessed a novel approach for monitoring of a single foot for the prevention and early detection of diabetic foot complications. The purpose of this study was to assess the sensitivity, specificity, and lead time associated with unilateral diabetic foot temperature monitoring.
Research design and methods We used comparisons among ipsilateral foot temperatures and between foot temperatures and ambient temperature as a marker of inflammation. We analyzed data collected from a 129-participant longitudinal study to evaluate the predictive accuracy of our approach. To evaluate classification accuracy, we constructed a receiver operator characteristic curve and reported sensitivity, specificity, and lead time for four different monitoring settings.
Results Using this approach, monitoring a single foot was found to predict 91% of impending non-acute plantar foot ulcers on average 41 days before clinical presentation with a resultant mean 4.2 alerts per participant-year. By adjusting the threshold temperature setting, the specificity could be increased to 78% with corresponding reduced sensitivity of 53%, lead time of 33 days, and 2.2 alerts per participant-year.
Conclusions Given the high incidence of subsequent diabetic foot complications to the sound foot in patients with a history of proximal LEA and patients being treated for a wound, practice of daily temperature monitoring of a single foot has the potential to significantly improve outcomes and reduce resource utilization in this challenging high-risk population.
- prevention
- remote monitoring
- foot ulceration
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Footnotes
Contributors LAL: concept and design, interpretation of results, and preparation and review of the manuscript. BJP: concept and design, analysis of data, interpretation of results, and preparation and review of the manuscript. DRL: concept and design, analysis of data, interpretation of results, and preparation and review of the manuscript. JDB: concept and design, interpretation of results, and preparation and review of the manuscript. GMR: concept and design, interpretation of results, and preparation and review of the manuscript. DGA: concept and design, interpretation of results, and preparation and review of the manuscript. All authors contributed in critically revising the manuscript and have given final approval of the version to be published.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests BJP, DRL, and JDB are employees of Podimetrics, Inc., a private company which designed and manufactured the study device and provided financial support sole sponsor of the study on which the analyses presented herein are based. GMR is a consulting Medical Director at Podimetrics, Inc.LAL and DGA are members of the Scientific Advisory Board of Podimetrics, Inc.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data may be obtained from a third party and are not publicly available.