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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetes patients | Adults with diagnosed type 1 or type 2 diabetes mellitus, without active foot ulcers |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIKMICRO® Mini2 V2 | Device | Low-cost infrared thermographic camera (256x192 px, NETD <40mK, cost ~200€) |
|
| 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with type 1 or type 2 diabetes mellitus attending the outpatient clinic for diabetic foot screening and assessment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eduardo Luis Martín Javier | Contact | +34 922 09 70 91 | eduardoluis.martin@universidadeuropea.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Europea de Canarias | La Orotava | Santa Cruz de Tenerife | 38300 | Spain |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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| HIKMICRO® M60 | Device | Professional infrared thermographic camera used as clinical reference standard |
|
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |