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 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT00956332
Eligibility Criteria:
Inclusion Criteria:
* Men and women 50 years of age or older
* Ischemic rest pain (Rutherford category 4) and/or
* Non-healing wounds (Rutherford category 5)
* ABI of 0.5 or less, or TBI of 0.3 or less
* Ankle systolic pressure of 70 mm Hg or less, or toe systolic pressure of 50 mm Hg or less
* Poor or no option for conventional revascularization
Exclusion Criteria:
* Life expectancy of less than one year
* Presence of significant inflow disease (\>50% stenosis) in the distal aorta, common or external iliac
* Advanced CLI, characterized by extensive tissue loss or gangrene (Rutherford category 6)
* Previous major amputation on the leg to be treated or planned major amputation within a month from enrollment
* Evidence of osteomyelitis
* Ischemic wounds with uncontrolled infectious symptoms
* Heart angioplasty or CABG within 3 months prior to enrollment
* Severe congestive heart failure (New York Heart Association stage IV)
* Acute cardiovascular event within 3 months prior to enrollment
* Uncontrolled blood pressure: SBP≥ 180 mmHg or DBP ≥110 mmHg
* Known Buerger's disease
* History of bleeding diathesis (e.g., hemophilia due to Factor VIII or IX deficiency)
* Renal failure defined as a serum creatinine \>2.5mg/dL
* Significant hepatic disease:\>3-fold elevation in ALT/AST, HBV or HCV carriers
* Severe pulmonary disease
* Active proliferative retinopathy and/or severe macular oedema
* Intra-ocular surgery within 6 months prior to enrollment
* Immunodeficient states (e.g. known HIV positivity, or organ transplant recipient) or subject receiving immunosuppressive medication
* History of malignant neoplasm (except curable non-melanoma skin malignancies) within 5 years prior to enrollment
* Pregnant or lactating women
* Previous treatment with angiogenic growth factors or stem cells
* No demonstrable venous access
* Known hypersensitivity to VEGF, Angiopoietin-1, or heparin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
90 Years
Study:
NCT00956332
Study Brief:
Protocol Section:
NCT00956332