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:
2025-12-24 @ 12:08 PM
Ignite Modification Date:
2025-12-24 @ 12:08 PM
NCT ID:
NCT05921461
Eligibility Criteria:
Inclusion Criteria:
* Men and Women
* Age \>40
* Subject must be willing and able to sign an Informed Consent form to participate in the clinical study.
Exclusion Criteria:
* Pregnant and breastfeeding woman
* Any severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for the purposes of this study.
Control group Inclusion Criteria:
• Good health according to self-report
Control group exclusion Criteria:
* History of diabetes and/or a cardiovascular disease according to self-report
* History of heavy smoking (20 cigarettes a day) for at least one year during the last 5 years prior to consent
* Family history of severe cardiovascular disease, i.e. sudden cardiac death below the age of 50, according to self-report
* Use of anti-hypertension drugs
PAD group Inclusion Criteria:
• Subjects who are suspected of having PAD and have undergone or are planned to undergo ABI testing within 60 days prior to or after ICF signature
PAD group exclusion Criteria:
* Existence of a WIfI graded severe foot infection (Infection grade 3) or severe infection (Infection grade 4), i.e. local infection or general infection with signs of systemic inflammatory response syndrome.
* Amputation or a surgical procedure on the foot during the last 2 weeks
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT05921461
Study Brief:
Protocol Section:
NCT05921461