Pilot Study of Hemospan® in Patients With Chronic Critical Limb Ischemia

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00633659
• Date of registration: 04/03/2008
• Primary sponsor: Sangart
• Public title: Pilot Study of Hemospan® in Patients With Chronic Critical Limb Ischemia
• Scientific title: A Phase II Study of Hemospan® Versus Voluven® to Evaluate Vascular Resistance and Forearm Blood Flow, and to Assess Local Skin Blood Flow and Tissue Oxygenation in the Ischemic Foot of Patients With Chronic Critical Limb Ischemia
• Date of first enrolment: September 2007
• Target sample size: 6
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00633659
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Countries of recruitment

Sweden

Contacts

• Name: Howard Levy, MD, PhD
• Affiliation: Sangart, Inc.

Key inclusion & exclusion 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



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Critical Lower Limb Ischemia

Vascular Disease

Intervention(s)

Drug: Hemospan®

Drug: Voluven®

Primary Outcome(s)

To investigate the effect of Hemospan on vascular resistance by evaluating blood flow in the forearm [Time Frame: 4 hours]

Secondary Outcome(s)

To evaluate the effects of Hemospan on local skin blood flow and tissue oxygenation in an ischemic region of the foot [Time Frame: 4 hours]

Secondary ID(s)

6034

Source(s) of Monetary Support

Please refer to primary and secondary sponsors