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

Sponsor
Eduardo Luis Martín Javier
Study ID
NCT07463456
Status
Not Yet Recruiting

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Conditions

  • Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HIKMICRO® Mini2 V2 — DEVICE
    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.
  • HIKMICRO® M60 — DEVICE
    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.

Study Details

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.

Key Dates

First listed
Mar 11, 2026
Start date
Oct 31, 2026
Status verified
Jul 2026
Primary completion
Apr 30, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
130 participants (estimated)

Arms

  • Arm: Diabetes patients
    Adults with diagnosed type 1 or type 2 diabetes mellitus, without active plantar ulceration, recruited from the active caseload of general podiatry and physiotherapy consultations.

Primary Outcome Measure

Intraclass correlation coefficient for absolute agreement, ICC(A,1), between the two cameras for contralateral thermal asymmetry (Delta T) in each of six pre-specified plantar regions of interest [ Time Frame: Single measurement session (Day 1) ]

Central Contacts

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