Instrumental Assessment of Plantar Hyperkeratosis in Healthy Subjects and Patients With Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Seville
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18 years
Presence of at least one clinically identifiable plantar hyperkeratosis
Intact skin without ulceration
Ability to maintain standing position for at least 30 seconds
Disqualifiers
Active plantar ulcer, pre-ulcerative lesion, or recent ulcer scar
Severe peripheral neuropathy (absence of protective sensation with 10 g monofilament)
Severe peripheral arterial disease (Ankle-Brachial Index < 0.8)
Foot surgery within the previous 6 months
Trial design
Design model
Parallel
Treatments tested in this trial
Instrumental Assessment of Plantar Hyperkeratosis
Diagnostic testStandardized, 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).
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Healthy Subjects With Plantar HyperkeratosisActive comparator 1 intervention
Group B: Diabetes Mellitus Without Active Foot UlcerActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Plantar Hyperkeratosis Surface Hardness (Shore A Scale)
Mean superficial hardness value measured using a calibrated Shore A durometer applied perpendicularly over the plantar hyperkeratosis. The average of three consecutive measurements will be analyzed.
Time frame
Baseline (day 0, single study visit)Secondary outcomes
1
Tissue Stiffness (Elastography)
Quantitative stiffness value obtained from ultrasound elastography within a standardized region of interest over the hyperkeratosis.
Time frame
Baseline (day 0, single study visit)2
Maximum and Mean Plantar Pressure at Hyperkeratosis Site
Maximum and mean plantar pressure values (kPa) recorded using a calibrated pressure platform during static stance.
Time frame
Baseline (day 0, single study visit)3
Surface Temperature of Plantar Hyperkeratosis (Infrared Thermography)
Mean and maximum surface temperature (°C) measured using standardized infrared thermography imaging.
Time frame
Baseline (day 0, single study visit)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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