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NCT Number: NCT07463456

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

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.

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Key information

Conditions

Diabetic Foot Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Glucose Metabolism Disorders Leg Ulcer Metabolic Diseases Nutritional and Metabolic Diseases Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidad Europea de Canarias

La Orotava, Santa Cruz de Tenerife, 38300, Spain

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years and older.
  • Diagnosed with Type 1 or Type 2 Diabetes Mellitus.
  • Ability to understand and sign the informed consent.

Exclusion criteria

  • Active foot ulcers.
  • Recent surgery on the lower limbs.
  • Cognitive impairment that prevents following the study protocol.

Treatment and study plan

HIKMICRO® Mini2 V2

Device

Low-cost infrared thermographic camera (256x192 px, NETD <40mK, cost ~200€)

HIKMICRO® M60

Device

Professional infrared thermographic camera used as clinical reference standard

Primary outcomes

  1. Intraclass Correlation Coefficient (ICC) of absolute agreement for maximum contralateral thermal asymmetry (Delta T_max) between HIKMICRO Mini2 V2 and M60

    Time frame: Single measurement session (Day 1)

    ICC calculated using a two-way mixed-effects model. ICC > 0.90 defined as excellent agreement. Delta T_max is the highest contralateral thermal asymmetry value among 6 plantar regions of interest per participant.

  2. Bland-Altman limits of agreement for Delta T_max

    Time frame: Single measurement session (Day 1)

Secondary outcomes

  1. Cohen's Kappa for binary classification of clinical risk hot spot (Delta T_max > 2.2 deg C)

    Time frame: Single measurement session (Day 1)

  2. Sensitivity and Specificity of HIKMICRO Mini2 V2 for hot spot detection using M60 as reference standard

    Time frame: Single measurement session (Day 1)

Study contacts

Contact information is provided by the study sponsor or research team.

Eduardo Luis Martín Javier

CONTACT

[email protected]

+34 922 09 70 91

Sponsors and collaborators

Lead sponsor

Universidad Europea de Canarias

Other

Registry information

Official study title

Thermographic Camera Validation for Diabetic Foot Assessment

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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