Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers
NCT ID: NCT04267640
Last Updated: 2021-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2020-01-30
2023-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 4.0 mg AMG0001 intramuscular (IM) (n = 20)
* 8.0 mg AMG0001 IM (n = 20)
* Placebo IM (n = 20)
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AMG0001 4mg
AMG0001 4mg + standard wound care
AMG0001
AMG0001 is a DNA Plasmid encoding hepatocyte growth factor (HGF) administered intramuscularly
AMG0001 8mg
AMG0001 8mg + standard wound care
AMG0001
AMG0001 is a DNA Plasmid encoding hepatocyte growth factor (HGF) administered intramuscularly
Placebo
Placebo + standard wound care
Placebo
Matching placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AMG0001
AMG0001 is a DNA Plasmid encoding hepatocyte growth factor (HGF) administered intramuscularly
Placebo
Matching placebo
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Subjects currently receiving immunosuppressive medication, systematically administered steroid therapy, chemotherapy or radiation therapy. Inhaled and topical steroid therapies are allowed
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AnGes USA, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
David G Armstrong, MD, DPM, PhD
Role: PRINCIPAL_INVESTIGATOR
Keck School of Medicine, USC
Michael S Conte, MD
Role: PRINCIPAL_INVESTIGATOR
Division of Vascular and Endovascular Surgery, UCSF
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
ILD Research Center
Carlsbad, California, United States
Rancho Research Institute
Downey, California, United States
Limb Preservation Platform, Inc.
Fresno, California, United States
Felix Sigal, D.P.M. A Professional Corporation
Los Angeles, California, United States
Center for Clinical Research Inc.
San Francisco, California, United States
University of California, San Francisco
San Francisco, California, United States
Goleta Valley Cottage Hospital
Santa Barbara, California, United States
BRCR Global
Deerfield Beach, Florida, United States
Doctors Research Network
South Miami, Florida, United States
Barry University Clinical Research
Tamarac, Florida, United States
Guardian Research/Florida Cardiology
Winter Park, Florida, United States
Gateway Clinical Trials, LLC
Belleville, Illinois, United States
Rosalind Franklin University Health Clinics
North Chicago, Illinois, United States
Brigham and Women's Hospital / Harvard Medical School
Boston, Massachusetts, United States
Advanced Foot & Ankle Center
Las Vegas, Nevada, United States
Vascular Solutions of North Carolina
Cary, North Carolina, United States
The Lindner Center for Research and Education at the Christ Hospital
Cincinnati, Ohio, United States
Lower Extremity Institute for Research and Therapy (LEIRT)
Youngstown, Ohio, United States
Oregon Health & Sciences University
Portland, Oregon, United States
Foot and Ankle Associates of Southwest Virginia
Salem, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AG-CLTI-0211
Identifier Type: -
Identifier Source: org_study_id