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Instrumental Assessment of Plantar Hyperkeratosis in Healthy Subjects and Patients With Diabetes
Sponsor: University of Seville
Summary
This randomized clinical trial aims to compare the diagnostic performance, reproducibility, and agreement of several non-invasive instrumental methods for assessing plantar hyperkeratosis hardness in healthy subjects and patients with diabetes mellitus without active foot ulceration. Participants will be evaluated in a single study session using plantar pressure platform analysis, durometer measurements, ultrasound elastography, and infrared thermography. The study seeks to identify the most reliable and discriminative methods for clinical and preventive assessment of plantar hyperkeratosis, particularly in populations at risk for diabetic foot complications.
Official title: Comparative Diagnostic Evaluation of Non-Invasive Instrumental Methods for Assessing Plantar Hyperkeratosis in Healthy Subjects and Patients With Diabetes Mellitus Without Active Ulceration
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-02
Completion Date
2026-06
Last Updated
2026-02-17
Healthy Volunteers
Yes
Conditions
Interventions
Instrumental Assessment of Plantar Hyperkeratosis
Standardized, non-invasive diagnostic assessment of plantar hyperkeratosis performed in a single session, including plantar pressure analysis (pressure platform), superficial hardness measurement (durometer, Shore A scale), tissue stiffness evaluation (ultrasound elastography), and surface temperature analysis (infrared thermography).