Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07412561
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT07412561
Study Brief:
Protocol Section:
NCT07412561