Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers
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
1 other identifier
interventional
60
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2020
Typical duration for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 30, 2020
CompletedFirst Submitted
Initial submission to the registry
February 7, 2020
CompletedFirst Posted
Study publicly available on registry
February 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedDecember 22, 2021
December 1, 2021
2.4 years
February 7, 2020
December 21, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Complete ulcer healing at 6 months
Complete ulcer healing defined as skin re-epithelialization without drainage or dressing requirements confirmed at 2 consecutive study visits 2 weeks apart.
Month 6
Time to complete ulcer healing
Complete ulcer healing defined as skin re-epithelialization without drainage or dressing requirements confirmed at 2 consecutive study visits 2 weeks apart.
Month 12
Secondary Outcomes (9)
The percentage reduction of ulcer size from baseline
Months 4, 6, 8, 10, 12
Hemodynamic measurements of toe pressure (TP)
Months 4, 6, 8, 10, 12
Hemodynamic measurements of ankle systolic pressure (ASP)
Months 4, 6, 8, 10, 12
Hemodynamic measurements of ankle brachial index (ABI)
Months 4, 6, 8, 10, 12
Hemodynamic measurements of toe brachial index (TBI)
Months 4, 6, 8, 10, 12
- +4 more secondary outcomes
Study Arms (3)
AMG0001 4mg
EXPERIMENTALAMG0001 4mg + standard wound care
AMG0001 8mg
EXPERIMENTALAMG0001 8mg + standard wound care
Placebo
PLACEBO COMPARATORPlacebo + standard wound care
Interventions
Eligibility Criteria
You may qualify if:
- 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 may not qualify 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 currently receiving immunosuppressive medication, systematically administered steroid therapy, chemotherapy or radiation therapy. Inhaled and topical steroid therapies are allowed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AnGes USA, Inc.lead
Study Sites (20)
ILD Research Center
Carlsbad, California, 92009, United States
Rancho Research Institute
Downey, California, 90242, United States
Limb Preservation Platform, Inc.
Fresno, California, 93710, United States
Felix Sigal, D.P.M. A Professional Corporation
Los Angeles, California, 90026, United States
Center for Clinical Research Inc.
San Francisco, California, 94117, United States
University of California, San Francisco
San Francisco, California, 94143, United States
Goleta Valley Cottage Hospital
Santa Barbara, California, 93111, United States
BRCR Global
Deerfield Beach, Florida, 33442, United States
Doctors Research Network
South Miami, Florida, 33143, United States
Barry University Clinical Research
Tamarac, Florida, 33321, United States
Guardian Research/Florida Cardiology
Winter Park, Florida, 32792, United States
Gateway Clinical Trials, LLC
Belleville, Illinois, 62226, United States
Rosalind Franklin University Health Clinics
North Chicago, Illinois, 60064, United States
Brigham and Women's Hospital / Harvard Medical School
Boston, Massachusetts, 02115, United States
Advanced Foot & Ankle Center
Las Vegas, Nevada, 89119, United States
Vascular Solutions of North Carolina
Cary, North Carolina, 27518, United States
The Lindner Center for Research and Education at the Christ Hospital
Cincinnati, Ohio, 45219, United States
Lower Extremity Institute for Research and Therapy (LEIRT)
Youngstown, Ohio, 44512, United States
Oregon Health & Sciences University
Portland, Oregon, 97239, United States
Foot and Ankle Associates of Southwest Virginia
Salem, Virginia, 24153, United States
Related Publications (1)
Armstrong DG, Conte MS, Mills JL, Menard MT, Orgill DP, Galiano RD, Kirsner RS, Farber A, Lantis JC, Zelen CM, Carter MJ, Hicks CW, Powell RJ. Anatomically Directed Lower Extremity Gene Therapy for Ulcer Healing: A Double-Blind, Randomized, Placebo-Controlled Study (LEGenD-1). Circ Cardiovasc Interv. 2025 Nov 4:e015648. doi: 10.1161/CIRCINTERVENTIONS.125.015648. Online ahead of print.
PMID: 41186002DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David G Armstrong, MD, DPM, PhD
Keck School of Medicine USC
- PRINCIPAL INVESTIGATOR
Michael S Conte, MD
Division of Vascular and Endovascular Surgery, UCSF
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 7, 2020
First Posted
February 13, 2020
Study Start
January 30, 2020
Primary Completion
July 1, 2022
Study Completion
January 1, 2023
Last Updated
December 22, 2021
Record last verified: 2021-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR