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 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT05749250
Eligibility Criteria:
Inclusion Criteria:
* Known history of unilateral or bilateral PAD diagnosed by reduced ankle-brachial index (\<0.9) or non-compressible vessels
* Diagnosis of CLI (Rutherford class IV-VI), and a non-healing ischemic ulcer defined as no change in the prior 3 months.
Exclusion Criteria:
* Major medical illness other than PAD affecting the limb (muscle disease, blood diseases that influence flow or rheology, severe heart failure \[NYHA class IV\]).
* Pregnant or lactating females
* Hypersensitivity to any ultrasound contrast agent or to polyethylene glycol (PEG, macrogol).
* Hemodynamic instability (hypotension with systolic BP \<90 mm Hg, need for vasopressors).
* Expected amputation or revascularization procedure within the ensuing 1 month.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05749250
Study Brief:
Protocol Section:
NCT05749250