Safety/Feasibility Study of HBOC-201 in Amputation at/Below Knee From Critical Lower Limb Ischemia

Inclusion Criteria: 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 Criteria: 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