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 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT00765050
Eligibility Criteria:
Inclusion Criteria:
* According to the investigator opinion, patient is able to carry out with all the clinical trial requirements
* Patient must volunteer sign the inform consent before any study specific test, that is not part of the common patient attention, is performed. Patient must know that he/she can abandon the study at any time with no damage to his/her posterior attention
* Age 18 to 75
* A diagnosis of chronic critic ischemia of the lower limbs
* Diabetes Mellitus active
* III or IV stages (Fontaine classification): resting pain, ulcer or minor gangrene with no major amputation
* General contraindication or local inoperability or refractory/progression after previous surgical treatment, according to the investigator criteria
* If female reproductive potential, negative pregnancy test
Exclusion Criteria:
* Pregnant or currently breast feeding women
* Acute myocardial infarction within the last 3 years
* Non re-vascular unstable angina pectoris
* History of ischemia stroke within the last 3 years
* Neoplasia at the time of inclusion or Chemotherapy or Radiotherapy treatment in the last 5 years
* Chronic renal insufficiency
* G-CSF contraindication
* A non well controlled serious concomitant disease
* History of serious thrombotic episodes within the past 3 years
* Patients who have received other investigational therapy within 30 days previous to the study inclusion
* Patients currently in other clinical trial or receiving any other investigational agent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00765050
Study Brief:
Protocol Section:
NCT00765050