chronic critical limb ischemia (CCLI)
Conditions
Interventions
Product Name: Hemospan®
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Maleimide-activated polyethylene glycol-modified human hemoglobin
Current Sponsor code: MalPEG-Hb
Other descrip
Sponsors
Sangart Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Severe congestive heart failure (EF 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). ;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 | — |
Countries
Sweden
Outcome results
None listed