This cross-sectional observational study validates the concordance of a low-cost thermographic camera (HIKMICRO Mini2 V2, \~200 Euro) against a professional clinical standard (HIKMICRO M60) for diabetic foot assessment. Both cameras simultaneously capture plantar thermographic images from 130 participants with diabetes mellitus. Maximum contralateral thermal asymmetry (Delta T\_max) across 6 plantar regions of interest (ROIs) is the primary endpoint, analyzed by intraclass correlation coefficient (ICC) and Bland-Altman method.
Study Type
OBSERVATIONAL
Enrollment
130
Low-cost infrared thermographic camera (256x192 px, NETD \<40mK, cost \~200€)
Professional infrared thermographic camera used as clinical reference standard
Universidad Europea de Canarias
La Orotava, Santa Cruz de Tenerife, Spain
Intraclass Correlation Coefficient (ICC) of absolute agreement for maximum contralateral thermal asymmetry (Delta T_max) between HIKMICRO Mini2 V2 and M60
ICC calculated using a two-way mixed-effects model. ICC \> 0.90 defined as excellent agreement. Delta T\_max is the highest contralateral thermal asymmetry value among 6 plantar regions of interest per participant.
Time frame: Single measurement session (Day 1)
Bland-Altman limits of agreement for Delta T_max
Time frame: Single measurement session (Day 1)
Cohen's Kappa for binary classification of clinical risk hot spot (Delta T_max > 2.2 deg C)
Time frame: Single measurement session (Day 1)
Sensitivity and Specificity of HIKMICRO Mini2 V2 for hot spot detection using M60 as reference standard
Time frame: Single measurement session (Day 1)
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