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

February 11, 2026 updated by: Ángel Díaz del Río, University of Seville

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Healthy Subjects With Plantar Hyperkeratosis
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
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).
Active Comparator: Diabetes Mellitus Without Active Foot Ulcer
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plantar Hyperkeratosis Surface Hardness (Shore A Scale)
Time Frame: 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.
Baseline (day 0, single study visit)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tissue Stiffness (Elastography)
Time Frame: Baseline (day 0, single study visit)
Quantitative stiffness value obtained from ultrasound elastography within a standardized region of interest over the hyperkeratosis.
Baseline (day 0, single study visit)
Maximum and Mean Plantar Pressure at Hyperkeratosis Site
Time Frame: Baseline (day 0, single study visit)
Maximum and mean plantar pressure values (kPa) recorded using a calibrated pressure platform during static stance.
Baseline (day 0, single study visit)
Surface Temperature of Plantar Hyperkeratosis (Infrared Thermography)
Time Frame: Baseline (day 0, single study visit)
Mean and maximum surface temperature (°C) measured using standardized infrared thermography imaging.
Baseline (day 0, single study visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Seville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 4, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US-DIAG-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus

Clinical Trials on Instrumental Assessment of Plantar Hyperkeratosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe