Digital foot health technology and diabetic foot monitoring: A systematic review.

<bold>Background: </bold>In diabetic foot ulceration, a correlation between pressure and skin temperature is suspected. The aim of this systematic review is to provide a more rigorous analysis of existing literature related to the various technologies used to read and measure both in-shoe plantar pressures, and in-shoe skin temperatures simultaneously.<bold>Methods: </bold>A systematic review of the literature related to the topic was searched in database sources such as Medline OVID, Cochrane Library, PubMed, CONAHL, PROSPERO, and Elsevier. Outcome measures of interest included validity, reliability and responsiveness of in-shoe temperature and/or pressure mapping device used, and characteristics and quantity of sensors used, anatomical landmarks and statistical analysis used to interpret the data. Quality of evidence and risk of bias was evaluated using the QUADAS-2.<bold>Results: </bold>Nineteen studies were identified and included in this review. The majority of studies used a small sample size (mean n = 17) and recruited healthy participants. All studies have shown excellent validity but only a few tested for the reliability of the device. None of the studies tested for responsiveness of the device. Quality assessment results scored high risk in view of 'patient selection', 'use of reference standard' and 'applicability', and low risk in view of 'use if index test' and 'flow and timing'.<bold>Conclusions: </bold>The data outlined in this review confirms that further improvement, reliability testing and clinical validation of the developed systems is required despite the results of excellent performance in detecting changes of in-shoe skin temperature and pressure. [ABSTRACT FROM AUTHOR]