Instrumental Assessment of Plantar Hyperkeratosis in Healthy Subjects and Patients With Diabetes

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.

NCT Number	NCT07412561
Lead Sponsor	University of Seville
Conditions	Diabetes Mellitus, Hyperkeratosis
Enrollment	50 participants
Start Date	2026-02
Primary Completion	2026-06 (estimated)
Study Completion	2026-06 (estimated)
Updated on ClinicalTrials.gov	2026-02-17