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

NCT07412561 | Not Yet Recruiting

• 1 other identifier: US-DIAG-2026
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus; Hyperkeratosis

Outcome Measures

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.

  Baseline (day 0, single study visit)

Secondary Outcomes (3)

• Tissue Stiffness (Elastography)

  Baseline (day 0, single study visit)

• Maximum and Mean Plantar Pressure at Hyperkeratosis Site

  Baseline (day 0, single study visit)

• Surface Temperature of Plantar Hyperkeratosis (Infrared Thermography)

  Baseline (day 0, single study visit)

Study Arms (2)

Healthy Subjects With Plantar Hyperkeratosis

ACTIVE COMPARATOR

Participants without diabetes mellitus presenting plantar hyperkeratosis who will undergo a single-session standardized instrumental assessment including pressure platform analysis, durometer measurement, elastography, and infrared thermography.

Diagnostic Test: Instrumental Assessment of Plantar Hyperkeratosis

Diabetes Mellitus Without Active Foot Ulcer

ACTIVE COMPARATOR

Participants diagnosed with diabetes mellitus (type 1 or type 2) without active foot ulcer, presenting plantar hyperkeratosis, who will undergo the same single-session standardized instrumental assessment including pressure platform analysis, durometer measurement, elastography, and infrared thermography.

Diagnostic Test: Instrumental Assessment of Plantar Hyperkeratosis

Interventions

Instrumental Assessment of Plantar Hyperkeratosis DIAGNOSTIC_TEST

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).

Diabetes Mellitus Without Active Foot Ulcer; Healthy Subjects With Plantar Hyperkeratosis

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• University of Seville: lead

MeSH Terms

Conditions

Diabetes Mellitus; Keratoderma, Palmoplantar, Epidermolytic

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Keratoderma, Palmoplantar, Diffuse; Keratoderma, Palmoplantar; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Ángel Díaz del Río, MSc

CONTACT

+34695985808; angdiadel@alum.us.es

Ángel Díaz del Río, MSc

CONTACT

+34695985808; angeldiazdelrio23@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 17, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02