Recruiting
Phase 2

AMG0001

Sponsor:

AnGes USA, Inc.

Code:

NCT04267640

Conditions

Peripheral Artery Disease

Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease

Chronic Limb Threatening Ischemia

Ischemic Ulcer of Foot

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

AMG0001

Placebo

Study Details

Brief 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.

Conditions

Peripheral Artery Disease

Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease

Chronic Limb Threatening Ischemia

Ischemic Ulcer of Foot

Study ID

NCT04267640

Start date

Jan 30, 2020

Status verified date

Dec, 2021

Completion date

Jan, 2023

Anticipated

Primary completion date

Jul, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AMG0001 4mg

AMG0001 4mg + standard wound care

experimental: AMG0001 8mg

AMG0001 8mg + standard wound care

placebo comparator: Placebo

Placebo + standard wound care

Interventions

AMG0001

AMG0001 is a DNA Plasmid encoding hepatocyte growth factor (HGF) administered intramuscularly

Placebo

Matching placebo

Primary outcome measure

  • Complete ulcer healing at 6 months [ Time Frame: Month 6 ]
  • Time to complete ulcer healing [ Time Frame: Month 12 ]

Central Contacts and Locations

Central contacts

Melton Affrime, PharmD

+1 908-444-3889maffrime@anges.co.jp

Chan Quach

+1 240-780-9033cquach@anges-usa.com

Locations

ILD Research Center

Recruiting

Carlsbad, California, United States, 92009

Rancho Research Institute

Recruiting

Downey, California, United States, 90242

Limb Preservation Platform, Inc.

Recruiting

Fresno, California, United States, 93710

Felix Sigal, D.P.M. A Professional Corporation

Recruiting

Los Angeles, California, United States, 90026

Center for Clinical Research Inc.

Recruiting

San Francisco, California, United States, 94117

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Goleta Valley Cottage Hospital

Recruiting

Santa Barbara, California, United States, 93111

BRCR Global

Recruiting

Deerfield Beach, Florida, United States, 33442

Doctors Research Network

Recruiting

South Miami, Florida, United States, 33143

Barry University Clinical Research

Recruiting

Tamarac, Florida, United States, 33321

Guardian Research/Florida Cardiology

Recruiting

Winter Park, Florida, United States, 32792

Gateway Clinical Trials, LLC

Recruiting

Belleville, Illinois, United States, 62226

Rosalind Franklin University Health Clinics

Recruiting

North Chicago, Illinois, United States, 60064

Brigham and Women's Hospital / Harvard Medical School

Recruiting

Boston, Massachusetts, United States, 02115

Advanced Foot & Ankle Center

Recruiting

Las Vegas, Nevada, United States, 89119

Vascular Solutions of North Carolina

Recruiting

Cary, North Carolina, United States, 27518

The Lindner Center for Research and Education at the Christ Hospital

Recruiting

Cincinnati, Ohio, United States, 45219

Lower Extremity Institute for Research and Therapy (LEIRT)

Recruiting

Youngstown, Ohio, United States, 44512

Oregon Health & Sciences University

Recruiting

Portland, Oregon, United States, 97239

Foot and Ankle Associates of Southwest Virginia

Recruiting

Salem, Virginia, United States, 24153

More Information

Sponsor

AnGes USA, Inc.

Last update posted

Dec 22, 2021

Last verified

Dec, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by AnGes USA, Inc. on 2021-12-22.