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 @ 10:15 PM
Ignite Modification Date:
2025-12-24 @ 10:15 PM
NCT ID:
NCT00731835
Eligibility Criteria:
Inclusion Criteria:
* The subject (male or non-pregnant female) must be greater than or equal to 18 years of age
* Ischemic ulcer of foot present
* An ankle-brachial index (ABI) of 0.4 to 0.8 or monophasic-biphasic waveforms on pulse volume recordings. (If the subject is diabetic or has renal failure, with incompressible vessels, a toe brachial index of 0.4 to 0.8 is required.)
* Signed informed consent
Exclusion Criteria:
* Severe ischemia as defined by advanced gangrene, an ABI of less then or equal to 0.3 and monophasic waveforms on pulse volume recording
* Advanced renal insufficiency, defined as serum creatinine greater than or equal to 3 mg/dl
* Absolute contraindication to contrast media, as determined by the investigator
* Unwilling or unable to provide informed consent or return for required follow-up evaluations.
* Previous enrollment in this clinical study
* Concurrent participation in another clinical research study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
110 Years
Study:
NCT00731835
Study Brief:
Protocol Section:
NCT00731835