Abstract
BackgroundThermal imaging is a useful modality for identifying preulcerative lesions (“hot spots”) in diabetic foot patients. Despite its recognised potential, at present, there is no readily available instrument for routine podiatric assessment of patients at risk. To address this need, a novel thermal imaging system was recently developed. This paper reports the reliability of this device for temperature assessment of healthy feet.MethodsPlantar skin foot temperatures were measured with the novel thermal imaging device (Diabetic Foot Ulcer Prevention System (DFUPS), constructed by Photometrix Imaging Ltd) and also with a hand-held infrared spot thermometer (Thermofocus® 01500A3, Tecnimed, Italy) after 20 min of barefoot resting with legs supported and extended in 105 subjects (52 males and 53 females; age range 18 to 69 years) as part of a multicentre clinical trial. The temperature differences between the right and left foot at five regions of interest (ROIs), including 1st and 4th toes, 1st, 3rd and 5th metatarsal heads were calculated. The intra-instrument agreement (three repeated measures) and the inter-instrument agreement (hand-held thermometer and thermal imaging device) were quantified using intra-class correlation coefficients (ICCs) and the 95% confidence intervals (CI).ResultsBoth devices showed almost perfect agreement in replication by instrument. The intra-instrument ICCs for the thermal imaging device at all five ROIs ranged from 0.95 to 0.97 and the intra-instrument ICCs for the hand-held-thermometer ranged from 0.94 to 0.97. There was substantial to perfect inter-instrument agreement between the hand-held thermometer and the thermal imaging device and the ICCs at all five ROIs ranged between 0.94 and 0.97.ConclusionsThis study reports the performance of a novel thermal imaging device in the assessment of foot temperatures in healthy volunteers in comparison with a hand-held infrared thermometer. The newly developed thermal imaging device showed very good agreement in repeated temperature assessments at defined ROIs as well as substantial to perfect agreement in temperature assessment with the hand-held infrared thermometer. In addition to the reported non-inferior performance in temperature assessment, the thermal imaging device holds the potential to provide an instantaneous thermal image of all sites of the feet (plantar, dorsal, lateral and medial views).Trial registrationDiabetic Foot Ulcer Prevention System NCT02317835, registered December 10, 2014
Highlights
Thermal imaging is a useful modality for identifying preulcerative lesions (“hot spots”) in diabetic foot patients
A recent health economics analysis has reported that the total expenditure on healthcare related to foot ulcer and amputation in people with diabetes for 2014– 2015 in England was estimated at £1billion [4]
The thermal imaging data was unavailable
Summary
Thermal imaging is a useful modality for identifying preulcerative lesions (“hot spots”) in diabetic foot patients. At present, there is no readily available instrument for routine podiatric assessment of patients at risk. To address this need, a novel thermal imaging system was recently developed. A recent health economics analysis has reported that the total expenditure on healthcare related to foot ulcer and amputation in people with diabetes for 2014– 2015 in England was estimated at £1billion [4]. Recent data show that at least 60,671–75,838 people with diabetes in England have foot ulcers at any given time (2–2.5% of the diagnosed diabetes population), and that the mean weekly cost of caring for each patient is £208 [4]. It has been estimated that reducing the prevalence of people with diabetic foot ulcers by one third could save the NHS £210 m–£262 m a year [4]
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