Diabetes MellitusNCT07412561
Instrumental Assessment of Plantar Hyperkeratosis in Healthy Subjects and Patients With Diabetes
A study testing Instrumental Assessment of Plantar Hyperkeratosis in people with Diabetes Mellitus and Hyperkeratosis, run by University of Seville.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Hyperkeratosis
- What is being tested?
- Instrumental Assessment of Plantar Hyperkeratosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- Medical diagnosis of type 1 or type 2 diabetes mellitus
- No active foot ulcer
- No history of foot ulcer within the previous 12 months
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Hyperkeratosis
- Being tested
- Instrumental Assessment of Plantar Hyperkeratosis
- Medical subject headings
- Diabetes Mellitus, Keratoderma, Palmoplantar, Epidermolytic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrumental Assessment of Plantar HyperkeratosisDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Instrumental Assessment of Plantar Hyperkeratosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (day 0, single study visit)
Secondary outcomes (3)
Tissue Stiffness (Elastography)
Quantitative stiffness value obtained from ultrasound elastography within a standardized region of interest over the hyperkeratosis.
Measured: Baseline (day 0, single study visit)
Maximum and Mean Plantar Pressure at Hyperkeratosis Site
Maximum and mean plantar pressure values (kPa) recorded using a calibrated pressure platform during static stance.
Measured: Baseline (day 0, single study visit)
Surface Temperature of Plantar Hyperkeratosis (Infrared Thermography)
Mean and maximum surface temperature (°C) measured using standardized infrared thermography imaging.
Measured: Baseline (day 0, single study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ángel Díaz del Río, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07412561
- Sponsor's protocol ID
- US-DIAG-2026
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07412561
- Acronym / sponsor ID
- US-DIAG-2026
- Conditions
- Diabetes Mellitus, Hyperkeratosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects With Plantar Hyperkeratosis | Active comparator | Diagnostic Test: Instrumental Assessment of Plantar HyperkeratosisParticipants 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. |
| Diabetes Mellitus Without Active Foot Ulcer | Active comparator | Diagnostic Test: Instrumental Assessment of Plantar HyperkeratosisParticipants 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Instrumental Assessment of Plantar HyperkeratosisStandardized, 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). | Diagnostic test | Diabetes Mellitus Without Active Foot Ulcer, Healthy Subjects With Plantar Hyperkeratosis |
Primary outcome
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.
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Instrumental Assessment of Plantar Hyperkeratosis in people with Diabetes Mellitus and Hyperkeratosis, run by University of Seville.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ángel Díaz del Río, MSc (+34695985808, angdiadel@alum.us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plantar Hyperkeratosis Surface Hardness (Shore A Scale) (time frame: Baseline (day 0, single study visit)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.