Health TrialsbyHealthPanel

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

ConditionsDiabetic FootDiabetes Mellitus
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversidad Europea de Canarias

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years and older.

Diagnosed with Type 1 or Type 2 Diabetes Mellitus.

Ability to understand and sign the informed consent.

Disqualifiers

Active foot ulcers.

Recent surgery on the lower limbs.

Cognitive impairment that prevents following the study protocol.

Trial population

Patients with type 1 or type 2 diabetes mellitus attending the outpatient clinic for diabetic foot screening and assessment.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

130 Participants
are divided into 1 treatment group
Group A: Diabetes patients2 interventions

Trial outcomes

Primary outcomes

1

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

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.

Time frame
Single measurement session (Day 1)
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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad Europea de Canarias

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: