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Study of HGF Via Plasmid Vector to Improve Perfusion in Critical Limb Ischemia

NCT00060892 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2008-01-11

No results posted yet for this study

Summary

The primary purpose of this study was to assess the overall safety of different dose regimens of AMG0001 (HGF transferred via plasmid vector) as well as evaluate the improvement of blood perfusion in subjects with critical limb ischemia (CLI). This study also evaluated the improvement in wound healing without adverse effects on the quality of life, as well as the potential reduction of amputation, mortality and rest pain in the CLI population.

Conditions

  • Arterial Occlusive Disease
  • Peripheral Vascular Disease
  • Ischemia

Interventions

GENETIC

HGF plasmid

Intramuscular injections into index leg on Days 0, 14, and 28

Sponsors & Collaborators

  • AnGes USA, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2006-05-31
Completion
2007-01-31

Countries

  • United States

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 NCT00060892 on ClinicalTrials.gov