Instrumental Assessment of Plantar Hyperkeratosis in Healthy Subjects and Patients With Diabetes
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Conditions studied: Diabetes Mellitus, Hyperkeratosis
In brief
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.
Key facts
- Study ID
- NCT07412561
- Run by
- University of Seville
- People needed
- 50
- Starts
- 2026-02-01
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2026-02-17
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
- Signed informed consent
- Additional Inclusion Criteria for Diabetes Mellitus Group:
- Medical diagnosis of type 1 or type 2 diabetes mellitus
- No active foot ulcer
- No history of foot ulcer within the previous 12 months
You may not qualify if…
- 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
- Active inflammatory, infectious, or dermatological condition at measurement site
- Use of keratolytic treatments or debridement within the previous 15 days
- Inability to complete the full assessment protocol
Full record on ClinicalTrials.gov
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