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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT00797056
Eligibility Criteria:
Inclusion Criteria:
* Patients must have critical limb ischemia secondary to PAD, as defined by the presence of a non-healing ulcer, rest pain, or dry gangrene.
* Patients must have a toe pressure ≤ 30 mm Hg.
* Patients must be ≥18 years old.
* Patient must be able to self-administer a daily subcutaneous injection or have a caregiver who is able to administer a daily subcutaneous injection.
* Patients must be taking or have no absolute contraindication to taking aspirin and clopidogrel. If they are not currently taking aspirin, they must be willing to take aspirin (81 mg daily) and clopidogrel (75 mg daily) for 14 days starting on the first day of G-CSF treatment.
* After being informed of the treatment involved, patients must give written consent. The patient should not have any serious medical or psychiatric illness that would prevent either the giving of informed consent or the receipt of treatment. A built-in period of one week from discussion of the trial and initiation of the trial will be mandatory for enrollment.
Exclusion Criteria:
* Patients with transmetatarsal or higher amputations in the affected limb are excluded.
* Patients who are candidates for a revascularization procedure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00797056
Study Brief:
Protocol Section:
NCT00797056