MedTrace Logo

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

NCT07463456 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 130

Last updated 2026-03-13

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Universidad Europea de Canarias

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2026-10-31
Completion
2026-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07463456 on ClinicalTrials.gov