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Not yet recruiting NCT07412561

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

No phase Interventional Diabetes Mellitus Hyperkeratosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Instrumental Assessment of Plantar Hyperkeratosis.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Hyperkeratosis. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparative Diagnostic Evaluation of Non-Invasive Instrumental Methods for Assessing Plantar Hyperkeratosis in Healthy Subjects and Patients With Diabetes Mellitus Without Active Ulceration

Overview

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 test Instrumental 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).

Primary outcome measures

  • Plantar Hyperkeratosis Surface Hardness (Shore A Scale) [Time frame: Baseline (day 0, single study visit)]
Secondary outcome measures (3)
  • Tissue Stiffness (Elastography) [Time frame: Baseline (day 0, single study visit)]
  • Maximum and Mean Plantar Pressure at Hyperkeratosis Site [Time frame: Baseline (day 0, single study visit)]
  • Surface Temperature of Plantar Hyperkeratosis (Infrared Thermography) [Time frame: Baseline (day 0, single study visit)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07412561 · US-DIAG-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗