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

March 10, 2026 updated by: Eduardo Luis Martín Javier, Universidad Europea de Canarias

Thermographic Camera Validation for Diabetic Foot Assessment

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Santa Cruz de Tenerife
      • La Orotava, Santa Cruz de Tenerife, Spain, 38300
        • Universidad Europea de Canarias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diabetes patients
Adults with diagnosed type 1 or type 2 diabetes mellitus, without active foot ulcers
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Single measurement session (Day 1)
Bland-Altman limits of agreement for Delta T_max
Time Frame: Single measurement session (Day 1)
Single measurement session (Day 1)

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
Single measurement session (Day 1)
Sensitivity and Specificity of HIKMICRO Mini2 V2 for hot spot detection using M60 as reference standard
Time Frame: Single measurement session (Day 1)
Single measurement session (Day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Europea de Canarias

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 5, 2026

First Submitted That Met QC Criteria

March 5, 2026

First Posted (Actual)

March 11, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HIK-DM-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus

Clinical Trials on HIKMICRO® Mini2 V2

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe