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
Qualifiers
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
Treatments tested in this trial
- Instrumental Assessment of Plantar Hyperkeratosis
Treatment groups
50 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov