NCT07463456

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

Thermographic Camera Validation for Diabetic Foot Assessment

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 130 (estimated)
• Sponsor: Universidad Europea de Canarias · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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

• Diabetic Foot
• Diabetes Mellitus

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-04-01
• Primary completion: 2026-10-01
• Completion: 2026-12-01
• First posted: 2026-03-11
• Last updated: 2026-03-13

Locations

1 site across 1 country: Spain