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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT01824069
Eligibility Criteria:
Inclusion Criteria:
1. Informed Consent.
2. \> 18 years.
3. Chronic arterial ischemia grades IV-V of Rutherford that affects at least one limb.
4. Arterial occlusion direct flow or distal femoropopliteal level.
5. No option for surgical or endovascular revascularization.
6. Life expectancy exceeding two years.
7. High probability of need for major amputation at 6 months (CLI nonrevascularizable).
8. Negative pregnancy test if applicable.
Exclusion Criteria:
1. Background of hematologic neoplasia or unresolved.
2. Hipertensión uncontrolled blood (\> 180/110).
3. Severe heart Insuficiencia (New York Heart Association \[NYHA\] IV) or ejection fraction \<30%.
4. Malignant ventricular, Arritmias.
5. Trombosis of deep vein the past three months.
6. active infection.
7. Infarto infarction or stroke the previous three months.
8. Medical or psychiatric illness of any kind which, in the opinion of the investigator, may be a reason for exclusion from the study.
9. Subjects with congenital or acquired immunodeficiencies. Hepatitis B and / or C or tuberculosis diagnosed at the time of inclusion, treponema.
10. Major surgery or severe trauma of the subject in the previous semester.
11. Administration of any investigational drug at present to three months prior to enrollment for this trial.
12. Pulmonary heart disease, in the opinion of the investigator, be unstable or is sufficiently serious to dismiss the patient from the study.
13. Infants or pregnant women.
14. Adult women of childbearing potential not using effective contraception during the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01824069
Study Brief:
Protocol Section:
NCT01824069