Petrova N L, Whittam A, MacDonald A, Ainarkar S, Donaldson A N, Bevans J, Allen J, Plassmann P, Kluwe B, Ring F, Rogers L, Simpson R, Machin G, Edmonds M E
1Diabetic Foot Clinic, King's College Hospital NHS Foundation Trust, Denmark Hill, London, SE5 9RS UK.
2Division of Diabetes and Nutritional Sciences, King's College London, London, UK.
J Foot Ankle Res. 2018 May 30;11:22. doi: 10.1186/s13047-018-0266-1. eCollection 2018.
Thermal 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.
Plantar 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).
Both 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.
This 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).
Diabetic Foot Ulcer Prevention System NCT02317835, registered December 10, 2014.
热成像技术是一种用于识别糖尿病足患者溃疡前病变（“热点”）的有用方法。尽管其潜力已得到认可，但目前尚无适用于对高危患者进行常规足病评估的现成仪器。为满足这一需求，最近开发了一种新型热成像系统。本文报告了该设备对健康足部温度评估的可靠性。
作为一项多中心临床试验的一部分，对105名受试者（52名男性和53名女性；年龄范围18至69岁）在腿部支撑并伸展、赤脚休息20分钟后，使用新型热成像设备（由Photometrix Imaging Ltd制造的糖尿病足溃疡预防系统（DFUPS））和手持式红外点温度计（Thermofocus® 01500A3，意大利Tecnimed公司）测量足底皮肤温度。计算五个感兴趣区域（ROI）（包括第1和第4趾、第1、第3和第5跖骨头）左右脚之间的温度差。使用组内相关系数（ICC）和95%置信区间（CI）对仪器内一致性（三次重复测量）和仪器间一致性（手持式温度计和热成像设备）进行量化。
两种设备在仪器重复性方面均显示出几乎完美的一致性。热成像设备在所有五个ROI处的仪器内ICC范围为0.95至0.97，手持式温度计的仪器内ICC范围为0.94至0.97。手持式温度计和热成像设备之间在仪器间一致性方面表现为实质性至完美，所有五个ROI处的ICC范围在0.94至0.97之间。
本研究报告了一种新型热成像设备与手持式红外温度计相比，在评估健康志愿者足部温度方面的性能。新开发的热成像设备在对定义的ROI进行重复温度评估时显示出非常好的一致性，并且在与手持式红外温度计进行温度评估时表现为实质性至完美的一致性。除了在温度评估方面报告的非劣效性能外，热成像设备还具有提供足部所有部位（足底、背侧、外侧和内侧视图）即时热图像的潜力。
糖尿病足溃疡预防系统NCT02317835，于2014年12月10日注册。
