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Study of Hepatocyte Growth Factor (HGF) Via Plasmid Vector to Improve Perfusion in Critical Limb Ischemia Patients With Peripheral Ischemic Ulcers

NCT00189540 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2021-10-28

Study results available
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Summary

The objective of this study is to test the hypothesis that AMG0001 treatment is safe and induces angiogenesis as detected by improved wound healing, reduction in amputation, improved pain at rest and hemodynamic measurement and to assess the effectiveness of the administrative method.

Conditions

  • Arterial Occlusive Disease
  • Peripheral Vascular Disease
  • Ischemia
  • Ulcers

Interventions

GENETIC

HGF plasmid

Intramuscular injections into the index leg on days 0, 14, and 28

GENETIC

Placebo

Intramuscular injections into the index leg on days 0, 14, and 28

Sponsors & Collaborators

  • AnGes USA, Inc.

    lead INDUSTRY

Principal Investigators

  • Richard Powell, MD · Dartmouth

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2008-07-31
Completion
2008-08-31
FDA Drug
Yes

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 NCT00189540 on ClinicalTrials.gov