Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 10:48 AM
Study NCT ID:
NCT07463456
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thermographic Camera Validation for Diabetic Foot Assessment (HIK-DM-2026)
Sponsor:
Universidad Europea de Canarias
Organization:
Study Overview
Official Title:
Thermographic Camera Validation for Diabetic Foot Assessment
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: