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

May 15, 2008 updated by: Biopure Corporation

Phase II, Multi-Center,Single-Blind,Placebo-Controlled Study,Evaluating Safety & Feasibility of HBOC-201 (Wound Healing Patients With Peripheral Vascular Disease & Undergoing Lower Limb Amputation Due to Critical Lower Limb Ischemia

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 amputation.

The hypothesis is that HBOC-201 will pass through the partially occluded lesions in the peripheral arteries in the lower extremity and promote the wound healing process by delivering oxygen to the oxygen deprived tissues. This will reduce the incidence of lower limb wound complications at 60 days post-surgery and may reduce the incidence of a second amputation.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 patients with a peripheral vascular occlusive disorder and who are undergoing lower limb amputation due to critical lower limb ischemia. Subjects will be randomized (1:1) to receive either HBOC-201 or a colloid control (HAES-steril® 6%).

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Africa
      • Tygerburg, South Africa, 7506
        • University of Stellenbosch
    • Guateng
      • Johannesburg, Guateng, South Africa, 2041
        • Johannesburg Hospital
      • Parktown West, Guateng, South Africa, 2193
        • Milpark Hospital
      • Pretoria, Guateng, South Africa, 0001
        • Pretoria Academic Hospital
  • United Kingdom
    • Oxfordshire
      • Headington, Oxfordshire, United Kingdom, OX3 9DU
        • John Radcliffe Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Hemoglobin glutamer 250 - bovine
Drug: Hemoglobin glutamer 250 - bovine
intravenous - 250ml/dose - 32.5g Hb (Concentration 13 +/- 1g/dL)
Other Names:
  • Hemopure
  • HBOC-201
Active Comparator: 2
6% Hydroxyethylstarch
Drug: 6% Hydroxyethylstarch
250ml for intravenous infusion
Other Names:
  • HAES-steril®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality at 60 days post amputation procedure
Time Frame: 60(±7 days) post-procedure follow-up visit
60(±7 days) post-procedure follow-up visit

Secondary Outcome Measures

Outcome Measure
Time Frame
30 day follow up mortality; Complete wound healing 30, 60 day follow up; Time to complete wound healing; Re-amputation 60 days; Hospital, ICU & rehab days; TcPO2 change; Quality of Life; Delayed wound healing/complications; Rehospitalization; Surgeries
Time Frame: 15(±3 days) , 30(±7 days) and 60(±7 days) post-procedure follow-up visits
15(±3 days) , 30(±7 days) and 60(±7 days) post-procedure follow-up visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biopure Corporation

Investigators

  • Study Director: A. Gerson Greenburg, MD, Ph.D., Biopure Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Anticipated)

June 1, 2008

Study Completion (Anticipated)

June 1, 2008

Study Registration Dates

First Submitted

March 6, 2006

First Submitted That Met QC Criteria

March 6, 2006

First Posted (Estimate)

March 8, 2006

Study Record Updates

Last Update Posted (Estimate)

May 16, 2008

Last Update Submitted That Met QC Criteria

May 15, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BIOSA001/BIOEU001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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