Clinical Trials Logo
  1. Home
  2. Arterial Occlusive Disease
  3. NCT00189540

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

Peripheral Vascular Disease Clinical Trial

Official title:
A Phase II Double-Blind, Randomized, Placebo-Controlled Study to Assess the Safety and Efficacy of AMG0001 to Improve Perfusion in Critical Limb Ischemia in Subjects Who Have Peripheral Ischemic Ulcers

Clinical Trial 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.

Clinical Trial Description

The primary goals of this study evaluating AMG0001 administration in CLI subjects will be to investigate the efficacy and safety of AMG0001. Specifically, the objectives are: 1. Assess efficacy of a dosing regimen of 4.0mg/3 mL AMG0001, administered on Days 0, 14, and 28 as measured by reduction in total wound area at Month 3. 2. Assess potential effects of angiogenesis associated with a dosing regimen of 4.0mg/3 mL AMG0001, administered on Days 0, 14, and 28 as measured by reduction in total wound area at Months 6 and 12, along with reduction in major amputations and improved pain at rest as measured on the VAS and hemodynamic measures (ABI/TBI) at Month 3 and Month 6. 3. Assess overall safety of AMG0001 in the Critical Limb Ischemia subject population as determined by physical examination, blood and urine analyses, electrocardiogram, vital signs, and by evaluation of adverse experiences during and after the course of treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00189540
Study type Interventional
Source AnGes USA, Inc.
Contact
Status Completed
Phase Phase 2
Start date August 2005
Completion date August 2008
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05335525 - Post-market Clinical Investigation of the Angio-Seal™ VIP VCD (ANGIO-SEAL CLOSE)
Active, not recruiting NCT01903044 - Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating Phase 1/Phase 2
Completed NCT02271529 - Zilver PTX Delivery System N/A
Completed NCT02228564 - BARD® Study of LIFESTREAM™ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease N/A
Recruiting NCT02054871 - RCT to Evaluate the Renal Protective Effects of Remote Ischaemic Preconditioning in Peripheral Angioplasty N/A
Completed NCT00822172 - Evaluation of Cilostazol in Combination With L-Carnitine Phase 4
Completed NCT00574782 - Evaluation of the Efficacy of Rosuvastatin in Daily Practice in Untreated High Risk Patients (CHALLENGE) N/A
Completed NCT00029991 - Extract of Ginkgo Biloba (EGB 761) and Vascular Function Phase 1/Phase 2
Completed NCT01355406 - Evaluation of Safety and Efficacy of the FlexStent® Femoropopliteal Self-Expanding Stent System N/A
Recruiting NCT05804097 - Does Increasing Oxygen Nurture Your Symptomatic Ischemic Ulcer Sufficiently? Phase 4
Recruiting NCT03638115 - The VaSecure BTK Study N/A
Active, not recruiting NCT03241459 - Safety and Efficacy of the SurVeil™ Drug-Coated Balloon N/A
Active, not recruiting NCT01661231 - Study to Determine the Performance of the Astron and Pulsar-18 Stents in Europe N/A
Completed NCT01722877 - JetStream (JS) Atherectomy in Femoropopliteal In-Stent Restenotic Lesions N/A
Completed NCT01444378 - Absolute Pro® MOMENTUM™ N/A
Completed NCT00753337 - The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study N/A
Completed NCT00593385 - Atrium iCAST Iliac Stent Pivotal Study N/A
Completed NCT00538226 - Evaluation of the Effect of the Flowaid Device in Increasing Local Circulation in the Leg Phase 1
Recruiting NCT00385385 - RESTORE-IT-Study of Rifalazil in Chlamydia Pneumoniae Seropositive Patients With a History of Atherosclerotic Disease Phase 2
Completed NCT00392509 - ALD-301 for Critical Limb Ischemia, Randomized Trial Phase 1/Phase 2