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 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT01734603
Eligibility Criteria:
Inclusion Criteria:
* Patient (male/female) between 18 and 80 years
* Patient with Fontaine stage II PAD confirmed by clinic, duplex ultrasound and ankle-to-brachial systolic blood pressure index
* Cardiac status compatible with an intensive gait rehabilitation (checked by a consultation with a cardiologist, including interview, clinical examination, electrocardiograph, and effort test on ergocycle).
* Volunteer to take part in the study, having sign the consent form after receiving sufficient information and the information leaflet
* Person affiliated to social security or the recipient of a similar scheme
Not Inclusion Criteria:
* Exercise tolerance limited by other factors than claudication (eg, coronary artery disease, dyspnea, poorly controlled blood pressure
* walking limited by other pathology
* osteoarticular lower limbs pathology
* abdominal aortic aneurysm \> 4 cm
* pseudo-flu-like feverish syndromes in evolution (myocarditis or pericarditis)
* Person deprived of liberty by a legal or administrative decision, person under legal protection
* Person currently participating in a clinical trial or having taken part in a clinical trial in the month preceding inclusion
* Patient presenting with a history of mental or psychiatric illness or any other factor restricting his/her ability to participate in an informed manner and in compliance with the protocol
Exclusion Criteria:
Impossibility to perform protocol whatever reason
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01734603
Study Brief:
Protocol Section:
NCT01734603