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Inter-Device Concordance of Plantar Thermal Asymmetry Measurement (HIK-DM-2026)

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

Last updated 2026-08-06

No results posted yet for this study

Summary

This cross-sectional observational study measures the inter-device concordance between two infrared thermographic cameras, a low-cost model (HIKMICRO Mini2 V2) and a high-resolution model (HIKMICRO M60), when measuring plantar skin temperature in adults with diabetes mellitus. Each participant undergoes two consecutive thermographic acquisitions, always less than 10 seconds apart, from a fixed tripod at 75 cm, under standardized environmental conditions. The order of the two cameras is randomized 1:1 at participant level (sequence A: M60 then Mini2 V2; sequence B: Mini2 V2 then M60). The primary endpoint is the agreement between the two devices for contralateral thermal asymmetry (Delta T) in each of six pre-specified plantar regions of interest (ROIs), quantified by the intraclass correlation coefficient (ICC) for absolute agreement, with the consistency ICC for mean plantar temperature (Tmean) as an exploratory endpoint.

The study is strictly metrological. Neither camera is a medical device under Regulation (EU) 2017/745, no clinical decision is derived from the measurements, and the study does not evaluate the detection, diagnosis, screening or prevention of any disease. Neither device is designated as a diagnostic reference standard. Participants with diabetes mellitus are included solely because plantar thermal variability is greater in this population, which makes the inter-device comparison metrologically demanding.

Conditions

Interventions

DEVICE

HIKMICRO® Mini2 V2

Low-cost infrared thermographic camera (256 x 192 pixels, NETD below 40 mK) used solely as a measuring instrument. It is not a medical device and no clinical decision is derived from its readings.

DEVICE

HIKMICRO® M60

High-resolution infrared thermographic camera (640 x 480 pixels, NETD below 35 mK) used as a technical comparator. It is not designated as a clinical or diagnostic reference standard.

Sponsors & Collaborators

  • Eduardo Luis Martín Javier

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2027-04-30
Completion
2027-07-31

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