研究目的
To validate a smartphone-based IR-camera against a high-end IR-camera for diabetic foot assessment.
研究成果
The smartphone-based IR-camera demonstrates excellent reliability and validity for assessing temperature differences between contralateral feet in people with diabetic foot complications, making it suitable for use in daily clinical practice for monitoring and preventing diabetic foot ulcers. Future research should focus on home implementation and development of automatic assessment algorithms.
研究不足
Limitations include: manual annotation of regions of interest which is susceptible to human error; all participants were under care for a DFU, lacking those with developing ulcers or ulcer-free feet for longer periods; contact with the setup in the high-end camera might have influenced foot temperature in some regions; and smaller toes showed lesser performance due to potential geometrical transformation errors.
1：Experimental Design and Method Selection:
A single-centre prospective clinical study design was used to compare plantar foot temperatures acquired with a smartphone-based IR-camera and a high-end IR-camera. Intra-class correlation coefficient (ICC(3,1)) and Bland-Altman plots were employed to test agreement, with the high-end camera as the gold standard. Clinical validity was assessed using diagnostic accuracy measures such as sensitivity and specificity.
2：Sample Selection and Data Sources:
A convenience sample of 32 participants with diabetes mellitus who had a current or recently healed diabetic foot ulcer was included from the multidisciplinary outpatient diabetic foot clinic of Hospital Group Twente. Participants were excluded if they had a major amputation above the ankle.
3：List of Experimental Equipment and Materials:
The smartphone-based IR-camera setup included the FLIR One for Android (second-generation), a Motorola XT1642 Moto G4 Plus smartphone, a 3D-printed mount, a camera tripod, and a black cloth. The high-end IR-camera setup included a FLIR SC305 thermal camera, a Canon Eos-40D for color, light module, thermal reference elements, foot support, and a wooden box with light shielding. Software used included the 'Thermal camera + for FLIR One' application, custom-made Matlab software, and Photoshop CC
4：Experimental Procedures and Operational Workflow:
20 Participants were seated supine with feet exposed for 5 minutes for temperature equilibration. Two sets of plantar IR and color images were taken: first with the smartphone-based setup at approximately 1-meter distance, and second with the high-end setup where feet were placed on support bars. Images were processed by delineating foot boundaries in color images using Photoshop, aligning IR images with Matlab, and calculating average temperatures in specified regions.
5：Data Analysis Methods:
Statistical analysis involved calculating ICC(3,1) and Bland-Altman plots for agreement, and diagnostic accuracy measures (sensitivity, specificity, etc.) for clinical validity, using Matlab and other statistical tools.
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FLIR One
second-generation for Android
FLIR Systems
Used as the smartphone-based IR-camera for acquiring plantar IR images of feet for diabetic foot assessment.
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FLIR SC305
SC305
FLIR Systems
Used as the high-end IR-camera for comparison and validation against the smartphone-based camera.
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Canon Eos-40D
Eos-40D
Canon
Used for color imaging in the high-end IR-camera setup.
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Motorola XT1642 Moto G4 Plus
XT1642 Moto G4 Plus
Motorola Mobility LLC
Smartphone used to operate the FLIR One IR-camera with the thermal camera application.
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Thermal camera + for FLIR One
Georg Friedrich
Smartphone application used for image acquisition with the FLIR One camera.
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Matlab
The MathWorks
Custom-made software used for image processing and data analysis in the high-end IR-camera setup.
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Photoshop CC 2015
CC 2015
Adobe Systems
Used for delineating foot boundaries in color images during post-processing.
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