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Thermographic Camera Validation for Diabetic Foot Assessment
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Universidad Europea de Canarias
La Orotava, Santa Cruz de Tenerife, Spain
Start Date
April 1, 2026
Primary Completion Date
October 1, 2026
Completion Date
December 1, 2026
Last Updated
March 13, 2026
130
ESTIMATED participants
HIKMICRO® Mini2 V2
DEVICE
HIKMICRO® M60
DEVICE
Lead Sponsor
Universidad Europea de Canarias
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07480161