CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
HGF plasmid +1 moregenetic
Likely dose
HGF plasmid administered intramuscularly into the index leg on days 0, 14, and 28AI-extracted
Key inclusion· 5
  • ✓Age 40 years or older
  • ✓Peripheral ischemic ulcer(s) present
  • ✓Severe hemodynamic insufficiency: ankle systolic <70 mmHg OR toe systolic <50 mmHg
  • ✓Poor candidate for standard revascularization (inadequate conduit, unfavorable anatomy, or poor operative risk)
Key exclusion· 13
  • ✕Vascular disease prognosis indicating major amputation (at or above ankle) within 4 weeks
  • ✕Buerger's disease (thromboangiitis obliterans)
  • ✕Hemodynamically significant aorto-iliac occlusive disease
  • ✕Revascularization procedure within 12 weeks that remains patent

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00189540
NCT00189540Phase 2Completed
CompareCT.gov

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

AnGes USA, Inc.·interventional·Posted Sep 19, 2005·Updated Oct 28, 2021

In Brief

A Phase 2 clinical trial evaluating HGF plasmid and Placebo for Arterial Occlusive Disease and 3 related conditions. Completed, enrolled 27 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArterial Occlusive Disease, Peripheral Vascular Disease, Ischemia, Ulcers
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartAug 1, 2005
Primary CompletionJul 1, 2008
Study CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 20.8 years ago

Interventions

HGF plasmidgenetic

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

Placebogenetic

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