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New study aims to find best way to measure foot calluses in diabetes

NCT ID NCT07412561

Diagnosis Sponsor: University of Seville Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares several non-invasive methods to measure foot calluses (plantar hyperkeratosis) in 50 people, half with diabetes and half without. The goal is to find the most reliable technique for assessing callus hardness and stiffness, which could help prevent foot ulcers in diabetes. Participants undergo a single session of pressure, hardness, stiffness, and temperature measurements.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help identify the best way to measure foot calluses, potentially leading to better prevention of foot ulcers in people with diabetes.
What could go wrong
This is a small, early-stage diagnostic study with only 50 participants. It does not test a treatment, so it may not directly change patient care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Keratoderma, Palmoplantar, Epidermolytic keratosis palmoplantar keratosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus Hyperkeratosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.