Wound Healing in Patients with Peripheral Vascular Disease and Who are Undergoing a Lower Limb Amputation due to Critical Lower Limb Ischemia
Conditions
Interventions
Product Name: Hemopure
Product Code: HBOC-201
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: hemoglobin glutamer 250 (bovine)
Other descriptive name: Polymerized Bovine Hemoglobin
Con
Sponsors
Biopure Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Subjects >18 years of age and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with life expectancy less than 60 days. -Any patient in whom the administration of 250 mL of colloidal solution daily for four consecutive days would be considered medically inappropriate. -Patient has amputation above the knee joint or below the ankle joint. -Patient has any amputation whereby primary skin closure is not technically feasible (e.g. Guillotine). These patients can later be randomized at the time of definitive amputation provided they meet the inclusion criteria. -Patient has any amputation in which there is known infection at the site of skin closure, unless the infection is successfully treated prior to enrollment. -Patient is a candidate for percutaneous or open surgery revascularization. -Patient with peripheral vascular occlusion due to a cardioarterial emboli. -Patient is a pregnant or breastfeeding woman. -Previously demonstrated beef product allergy. -Renal dysfunction requiring dialysis, or serum creatinine level >2.50 mg/dL(>220 micromol/L) -Cardiac failure as defined by a NY class III/IV or left ventricular ejection fraction 18 mm Hg) -Symptomatic cerebrovascular disease (e.g., stroke) diagnosed within last 6 months or known high grade carotid stenosis -Uncontrolled diabetes as defined by a blood glucose = 400 mg/dL ( = 22 mmol/L) -Patients with uncontrolled hypertension as defined by a blood pressure > 160 / 90 mm Hg despite the use of at least two antihypertensive medications or > 180 / 100 mm Hg if untreated -Severe liver dysfunction as defined by total bilirubin = 3 mg/dL ( = 51 micromol/L) or an increase two times over the normal level of serum aspartate aminotransferase (AST) or serum alanine aminotransferase (ALT) -Systemic mastocytosis -Participation in another trial with an investigational drug or device including the follow-up period, within the last 30 days before enrollment -Severe or unstable hepatic, gastrointestinal, cardiovascular, respiratory, neurological, psychiatric, hematological, renal or dermatological disease, or any other medical condition that might interfere with the evaluation of study medication -Patient or legal representative is unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is: 1) to evaluate the safety of HBOC-201 in people who have peripheral vascular disease and who are having a lower limb amputation;Secondary Objective: The secondary objectives of this study are: 1) to determine if HBOC-201 (Hemopure®) can enhance wound healing in patients with advanced peripheral vascular disease who are having a through or below-the-knee but above the ankle amputation. 2) to determine if HBOC-201 will reduce wound complications and thus reduce the need for re-amputation at a higher level.;Primary end point(s): The primary end point of this study is: Safety of Product (60 day mortality) The secondary end point of this study is: Effect of product on wound healing. Specifically if wound healing is more complete than control (placebo) group and if the incidence of re-amputation is decreased. | — |
Countries
United Kingdom
Outcome results
None listed