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 @ 6:51 PM
Ignite Modification Date:
2025-12-24 @ 6:51 PM
NCT ID:
NCT00059657
Eligibility Criteria:
Inclusion Criteria:
* Critical leg ischemia (CLI) defined as distal extremity pain at rest, or peripheral ischemic ulcer(s), with severe hemodynamic impairment as diagnosed by ankle systolic pressure, toe systolic pressure or TcPO2
* Subjects will already be scheduled to receive a revascularization procedure (e.g., by-pass graft, endovascular procedure, etc.) involving a distal target artery below the knee joint (e.g., below the knee joint popliteal, anterior/posterior tibial, peroneal, plantar, pedal, etc.) as part of their normal standard of care.
Exclusion Criteria:
* Subjects with a previous major amputation (at or above ankle)
* Subjects with end stage renal disease (ESRD) defined as significant renal dysfunction evidenced by estimated creatinine clearance of \< 20 cc/min, or receiving chronic hemodialysis therapy.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT00059657
Study Brief:
Protocol Section:
NCT00059657