A randomized, single-blind, controlled Phase II pilot study of Hemospan® compared with colloid (Voluven®) to evaluate vascular resistance and blood flow in the forearm, and to assess local skin blood flow and tissue oxygenation in an ischemic region of the foot in patients with chronic critical limb ischemia (CCLI)
- Conditions
- chronic critical limb ischemia (CCLI)
- Registration Number
- EUCTR2007-001538-15-SE
- Lead Sponsor
- Sangart Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•Adult male or female (surgically sterile or post-menopausal) patients with CCLI that meet the following definition:
- History of pain at rest and/or ulceration
- Ankle systolic BP/Brachial systolic BP Index (ABI) <0.6 at the time of inclusion
- Ankle systolic BP <70 mmHg and/or toe systolic BP <50 mmHg
•Has been given written and verbal information about the investigational product and the protocol by a study 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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•Severe congestive heart failure (EF <40% or New York Heart Assoc. 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): The primary assessment (‘endpoint’) for efficacy will be the maximum change from baseline in the vascular resistance calculated from plethysmography assessment of blood flow changes in the forearm following infusion (assessed during a minimum period of 2 hours but not more than 4 hours after start of infusion).<br><br>;Main Objective: To investigate the effect of Hemospan on vascular resistance by evaluating blood flow in the forearm. ;Secondary Objective: To evaluate the effects of Hemospan on local skin blood flow and tissue oxygenation in an ischemic region of the foot in patients with CCLI
- Secondary Outcome Measures
Name Time Method