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

NCT07463456 | Not Yet Recruiting

• 1 other identifier: HIK-DM-2026-01
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Foot; Diabetes Mellitus

Keywords

thermography; infrared; concordance; ICC; low-cost; HIKMICRO; plantar temperature; diabetic foot screening

Outcome Measures

Primary Outcomes (2)

• 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.

  Single measurement session (Day 1)

• Bland-Altman limits of agreement for Delta T_max

  Single measurement session (Day 1)

Secondary Outcomes (2)

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

  Single measurement session (Day 1)

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

  Single measurement session (Day 1)

Study Arms (1)

Diabetes patients

Adults with diagnosed type 1 or type 2 diabetes mellitus, without active foot ulcers

Device: HIKMICRO® Mini2 V2; Device: HIKMICRO® M60

Interventions

HIKMICRO® Mini2 V2 DEVICE

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

Diabetes patients

HIKMICRO® M60 DEVICE

Professional infrared thermographic camera used as clinical reference standard

Diabetes patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidad Europea de Canarias: lead

Study Sites (1)

Universidad Europea de Canarias

La Orotava, Santa Cruz de Tenerife, 38300, Spain

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Eduardo Luis Martín Javier

CONTACT

+34 922 09 70 91; eduardoluis.martin@universidadeuropea.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Podiatrist, PhD Candidate

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 11, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)