Thermographic Camera Validation for Diabetic Foot Assessment (HIK-DM-2026)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversidad Europea de Canarias
About this trial
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.
Eligibility criteria
Qualifiers
Age 18 years and older.
Diagnosed with Type 1 or Type 2 Diabetes Mellitus.
Ability to understand and sign the informed consent.
Disqualifiers
Active foot ulcers.
Recent surgery on the lower limbs.
Cognitive impairment that prevents following the study protocol.
Trial design
Treatments tested in this trial
- HIKMICRO® Mini2 V2
- HIKMICRO® M60
Treatment groups
130 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov