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

NCT00300040 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2008-05-16

No results posted yet for this study

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 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.

Conditions

  • Peripheral Vascular Disease

Interventions

DRUG

Hemoglobin glutamer 250 - bovine

intravenous - 250ml/dose - 32.5g Hb (Concentration 13 +/- 1g/dL)

DRUG

6% Hydroxyethylstarch

250ml for intravenous infusion

Sponsors & Collaborators

  • Biopure Corporation

    lead INDUSTRY

Principal Investigators

  • A. Gerson Greenburg, MD, Ph.D. · Biopure Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • South Africa
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00300040 on ClinicalTrials.gov