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 @ 11:48 AM
Ignite Modification Date:
2025-12-24 @ 11:48 AM
NCT ID:
NCT00730561
Eligibility Criteria:
Inclusion Criteria:
* Ambulatory patients with type 2 diabetes mellitus and ischemia of one or both lower limbs, defined as lack of limb improvement with conventional care (medications, debridements) after a recent amputation or a patient graded III or IV in the Leriche-Fontaine functional classification.
Exclusion Criteria:
* Patients older than 75 years
* Hypercoagulable states
* Cardiac ejection fraction \< 30%
* Active vasculopathy in brain, kidneys or heart
* Neoplastic disease
* Active infection
* Diabetic ketoacidosis or hyperosmolar hyperglycemic state
* Gangrene of the extremity requiring immediate surgery.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT00730561
Study Brief:
Protocol Section:
NCT00730561