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 @ 2:47 PM
Ignite Modification Date:
2025-12-24 @ 2:47 PM
NCT ID:
NCT00633659
Eligibility Criteria:
Inclusion Criteria:
* Adult male or female (surgically sterile or post-menopausal) patients with CCLI that meet the following definition: i) History of pain at rest and/or ulceration; ii) Ankle systolic BP/Brachial systolic BP Index (ABI) \<0.6 at the time of inclusion; iii) Ankle systolic BP \<70 mmHg and/or toe systolic BP \<50 mmHg
* Has received written and verbal information about the investigational product and the protocol by the investigator and has had the opportunity to ask questions about the study
* Patients must sign an Informed Consent Form (ICF), that has been reviewed and approved by the independent Ethics Committee (EC)
Exclusion Criteria:
* Severe congestive heart failure (EF \<40%, or New York Heart Association Class III or IV
* Any acute or chronic condition that will limit the patient's ability to complete the study
* Recent acute coronary syndrome (unstable angina or myocardial infarction \[MI\] within 1 month)
* Severe dementia or clinically significant psychiatric disorder requiring active treatment
* Evidence of untreated or uncontrolled hypertension (SBP \>180 mmHg, or DBP \>100 mmHg), or a difference in systolic BP in each arm that is \>15 mmHg (measured by cuff and a pen-Doppler at screening in the supine position, in both arms)
* Smoking or use of any nicotine-containing product (e.g., snuff) within previous 24 hours before start of study
* Any systemic rheumatic disease
* Taking oral steroid therapy (does not include steroids taken intermittently via inhaler)
* Chronic hepatic disease (abnormal LFTs \>3X upper limit of normal, known history of Hepatitis C or B)
* Chronic renal disease (creatinine \>1.8 mg/dL, or known polycystic kidney disease)
* Expectation of poor patient compliance with study protocol
* Patients scheduled for surgical procedure within 7 days from start of this study
* Involved in any investigational drug or device trial within 30 days prior to this study
* Professional or ancillary personnel involved with this study
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00633659
Study Brief:
Protocol Section:
NCT00633659