Status:
TERMINATED
Safety/Feasibility Study of HBOC-201 in Amputation at/Below Knee From Critical Lower Limb Ischemia
Lead Sponsor:
Biopure Corporation
Conditions:
Peripheral Vascular Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the safety and feasibility of HBOC-201 in increasing adequate wound healing in patients with severe peripheral vascular disease who are undergoing lower limb amp...
Detailed Description
This is a Phase II, single-blinded, prospectively randomized, parallel-group, placebo controlled study that will evaluate the safety and feasibility of HBOC-201 when administered therapeutically to pa...
Eligibility Criteria
Inclusion
- Subjects ≥ 18 ≤ 75 years of age
- Scheduled amputation at or above ankle joint, or a more proximal location but below or through the knee joint
- Documented severe lower extremity peripheral artery occlusive disease confirmed by clinical symptoms of critical limb ischemia and:
- Frankly gangrenous tissue that merits amputation or
- Angiographic evidence of occlusive peripheral artery disease within one month of screening
- Participant or legal representative signs informed consent
- Willingness to follow study instructions and follow-up visits
Exclusion
- No informed consent is obtained
- If medically inappropriate to administer 250 mL colloidal solution daily for 4 consecutive days
- Uncontrolled hypertension (BP \> 160/90 mm Hg) despite 2 antihypertensive meds or BP \> 180/100 mm Hg if untreated
- Severe liver dysfunction defined by Total Bilirubin \> 3 mg/dL or twice the normal limit of serum AST or ALT
- Symptomatic CVD diagnosed w/ in last 6 months or known high grade carotid stenosis
- Any severe or unstable medical condition that might interfere w/ the evaluation of study medication
- Cardiogenic shock (cardiac index \< 2 L/min/m2, PCWP \> 18 mm Hg)
- Amputation above knee joint or below ankle joint
- Any amputation whereby primary skin closure not technically feasible
- Candidate for percutaneous or surgical revascularization
- Cardiac failure defined by a NY class III/IV or left ventricular ejection fraction \< 30%
- Life expectancy \< 60 days
- Systemic mastocytosis
- Previously demonstrated beef product allergy
- Myocardial infarction w/ in 30 days
- Participation in another trial w/ in last 30 days
- Woman who is pregnant or breastfeeding
- Amputation with known infection at site of skin closure
- Renal dysfunction requiring dialysis, or serum creatinine level 2.5 mg/dL
- Peripheral vascular occlusion from cardio arterial emboli
- Uncontrolled diabetes blood glucose ≥ 400 mg/dL
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00300040
Start Date
May 1 2006
End Date
June 1 2008
Last Update
May 16 2008
Active Locations (5)
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1
Johannesburg Hospital
Johannesburg, Guateng, South Africa, 2041
2
Milpark Hospital
Parktown West, Guateng, South Africa, 2193
3
Pretoria Academic Hospital
Pretoria, Guateng, South Africa, 0001
4
University of Stellenbosch
Tygerburg, South Africa, 7506