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NCT07463456

Thermographic Camera Validation for Diabetic Foot Assessment (HIK-DM-2026)

Sponsor: Universidad Europea de Canarias

View on ClinicalTrials.gov

Summary

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.

Official title: Thermographic Camera Validation for Diabetic Foot Assessment

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

130

Start Date

2026-04

Completion Date

2026-12

Last Updated

2026-03-13

Healthy Volunteers

Not specified

Interventions

DEVICE

HIKMICRO® Mini2 V2

Low-cost infrared thermographic camera (256x192 px, NETD \<40mK, cost \~200€)

DEVICE

HIKMICRO® M60

Professional infrared thermographic camera used as clinical reference standard

Locations (1)

Universidad Europea de Canarias

La Orotava, Santa Cruz de Tenerife, Spain