Thermographic Camera Validation for Diabetic Foot Assessment
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Universidad Europea de Canarias
- Enrollment
- 130
- Locations
- 1
- Primary Endpoint
- Intraclass Correlation Coefficient (ICC) of absolute agreement for maximum contralateral thermal asymmetry (Delta T_max) between HIKMICRO Mini2 V2 and M60
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Diabetes patients
Adults with diagnosed type 1 or type 2 diabetes mellitus, without active foot ulcers
Intervention: HIKMICRO® Mini2 V2 (Device)
Diabetes patients
Adults with diagnosed type 1 or type 2 diabetes mellitus, without active foot ulcers
Intervention: HIKMICRO® M60 (Device)
Outcomes
Primary Outcomes
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.
Bland-Altman limits of agreement for Delta T_max
Time Frame: Single measurement session (Day 1)
Secondary Outcomes
- 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))
Investigators
Eduardo Luis Martín Javier
Podiatrist, PhD Candidate
Universidad Europea de Canarias