for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study start
estimated completion
Principal Investigator
by Michael S Conte, MD
Headshot of Michael S Conte
Michael S Conte



This study will assess the safety and efficacy of intramuscular injection of AMG0001 (hepatocyte growth factor [HGF] plasmid) to improve ulcer healing and perfusion in patients with peripheral artery disease.

Official Title

A Phase II Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects Who Have Peripheral Ischemic Ulcers of the Lower Extremity


This is a Phase 2, double-blind, randomized, placebo-controlled, parallel group study. Approximately 60 male or female subjects aged 18 years or older with one shallow foot ulcer and mild/moderate ischemia due to peripheral artery disease (PAD) will be randomized in a 1:1:1 ratio to one of 3 treatment groups:

  • 4.0 mg AMG0001 intramuscular (IM) (n = 20)
  • 8.0 mg AMG0001 IM (n = 20)
  • Placebo IM (n = 20)


Peripheral Artery Disease, Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease, Chronic Limb Threatening Ischemia, Ischemic Ulcer of Foot, Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Ischemia, Ulcer, AMG0001, AMG0001 4mg, AMG0001 8mg


You can join if…

Open to people ages 18 years and up

  • Documented diagnosis of PAD and mild/moderate foot ischemia (WIFI ischemia grades 1, 2)
  • A single measurable ulcer of ≥ 1 cm2 and ≤ 10 cm2 on a lower extremity without evidence of infection or gangrene and no evidence of bone and/or tendon involvement at randomization
  • Subjects will undergo protocol-defined standardized wound care during the screening period and through 12 months from the first dose of investigational product
  • Subjects who have a diagnosis of diabetes must be considered stable with no changes in diabetic medication regimen anticipated during the study period. Subjects who have a diagnosis of diabetes must have a HbA1c of ≤12% at Screening

You CAN'T join if...

  • Subjects who have excessive tissue necrosis that is unlikely to benefit from medication, or those subjects who, in the opinion of the Investigator, are felt likely to require revascularization within 1 month of screening
  • Subjects with severe limb ischemia
  • Subjects who are considered likely to require a major amputation (at or above the ankle) within 3 months of screening
  • Subjects with deep ulcerations with bone or tendon exposure, or uncontrolled infection, or with the largest ulcer that is >10 cm2 in area
  • Subjects with hemodynamically significant aorto-iliac occlusive disease
  • Subjects who have had a technically successful revascularization by surgery or angioplasty within 2 months. If subjects are more than two months from revascularization and still meet the inclusion criteria, they may be considered for enrollment. Subjects who have had a technically unsuccessful attempt at revascularization may be enrolled at least one week from the procedure
  • Subjects currently receiving immunosuppressive medication, systematically administered steroid therapy, chemotherapy or radiation therapy. Inhaled and topical steroid therapies are allowed


  • UCSF accepting new patients
    San Francisco California 94143 United States
  • Center for Clinical Research Inc. accepting new patients
    San Francisco California 94117 United States
  • Limb Preservation Platform, Inc. accepting new patients
    Fresno California 93710 United States

Lead Scientist at UCSF

  • Michael S Conte, MD
    Professor, Surgery, School of Medicine. Authored (or co-authored) 295 research publications


accepting new patients
Start Date
Completion Date
AnGes USA, Inc.
Phase 2 research study
Study Type
Expecting 60 study participants
Last Updated