Instrumental Assessment of Plantar Hyperkeratosis in Healthy Subjects and Patients With Diabetes (NCT07412561) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Instrumental Assessment of Plantar Hyperkeratosis in Healthy Subjects and Patients With Diabetes
50 participantsStarted 2026-02
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plantar Hyperkeratosis Surface Hardness (Shore A Scale)