Summary

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

Description

Summary

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

Details

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)

Keywords

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

Eligibility

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

Locations

  • University of California, San Francisco 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

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AnGes USA, Inc.
ID
NCT04267640
Phase
Phase 2
Study Type
Interventional
Last Updated