Diabetes Mellitus, Hyperkeratosis
Conditions
Brief 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.
Detailed description
This is a randomized, controlled, cross-sectional clinical trial with two parallel groups: healthy subjects and patients with diabetes mellitus without active or recent plantar ulceration. All participants present at least one clinically identifiable plantar hyperkeratosis. Each subject undergoes a standardized assessment in a single session using four non-invasive instrumental techniques: plantar pressure platform, durometer, ultrasound elastography, and infrared thermography. The order of application of the instrumental methods is randomized. Primary outcomes include superficial hardness, tissue stiffness, plantar pressure distribution, and plantar surface temperature. Secondary outcomes include demographic, anthropometric, and clinical variables. The study aims to compare inter-group differences, method agreement, reproducibility, and discriminative capacity of each instrumental technique.
Interventions
DIAGNOSTIC_TESTInstrumental 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).
Sponsors
University of Seville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
The statistical analyst assessing study outcomes will be blinded to participant group allocation. Due to the nature of the instrumental assessments, participant and investigator blinding was not feasible.
Intervention model description
Two parallel groups (healthy subjects and individuals with diabetes mellitus) undergoing a single-session, non-therapeutic instrumental assessment of plantar hyperkeratosis using pressure platform, durometer, elastography, and infrared thermography.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plantar Hyperkeratosis Surface Hardness (Shore A Scale) | Baseline (day 0, single study visit) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum and Mean Plantar Pressure at Hyperkeratosis Site | Baseline (day 0, single study visit) | Maximum and mean plantar pressure values (kPa) recorded using a calibrated pressure platform during static stance. |
| Surface Temperature of Plantar Hyperkeratosis (Infrared Thermography) | Baseline (day 0, single study visit) | Mean and maximum surface temperature (°C) measured using standardized infrared thermography imaging. |
| Tissue Stiffness (Elastography) | Baseline (day 0, single study visit) | Quantitative stiffness value obtained from ultrasound elastography within a standardized region of interest over the hyperkeratosis. |
Contacts
CONTACTÁngel Díaz del Río, MSc
Outcome results
None listed