Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers

December 21, 2021 updated by: AnGes USA, Inc.

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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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)

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Carlsbad, California, United States, 92009
        • Recruiting
        • ILD Research Center
      • Downey, California, United States, 90242
        • Recruiting
        • Rancho Research Institute
      • Fresno, California, United States, 93710
        • Recruiting
        • Limb Preservation Platform, INC.
      • Los Angeles, California, United States, 90026
        • Recruiting
        • Felix Sigal, D.P.M. A Professional Corporation
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
      • San Francisco, California, United States, 94117
        • Recruiting
        • Center for Clinical Research Inc.
      • Santa Barbara, California, United States, 93111
        • Recruiting
        • Goleta Valley Cottage Hospital
    • Florida
      • Deerfield Beach, Florida, United States, 33442
        • Recruiting
        • BRCR Global
      • South Miami, Florida, United States, 33143
        • Recruiting
        • Doctors Research Network
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • Barry University Clinical Research
      • Winter Park, Florida, United States, 32792
        • Recruiting
        • Guardian Research/Florida Cardiology
    • Illinois
      • Belleville, Illinois, United States, 62226
        • Recruiting
        • Gateway Clinical Trials, LLC
      • North Chicago, Illinois, United States, 60064
        • Recruiting
        • Rosalind Franklin University Health Clinics
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital / Harvard Medical School
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Recruiting
        • Advanced Foot & Ankle Center
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Recruiting
        • Vascular Solutions of North Carolina
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • The Lindner Center for Research and Education at The Christ Hospital
      • Youngstown, Ohio, United States, 44512
        • Recruiting
        • Lower Extremity Institute for Research and Therapy (LEIRT)
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Sciences University
    • Virginia
      • Salem, Virginia, United States, 24153
        • Recruiting
        • Foot and Ankle Associates of Southwest Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AMG0001 4mg
AMG0001 4mg + standard wound care
Biological: AMG0001
AMG0001 is a DNA Plasmid encoding hepatocyte growth factor (HGF) administered intramuscularly
Other Names:
  • HGF plasmid
  • Collategene
  • beperminogene perplasmid
Experimental: AMG0001 8mg
AMG0001 8mg + standard wound care
Biological: AMG0001
AMG0001 is a DNA Plasmid encoding hepatocyte growth factor (HGF) administered intramuscularly
Other Names:
  • HGF plasmid
  • Collategene
  • beperminogene perplasmid
Placebo Comparator: Placebo
Placebo + standard wound care
Biological: Placebo
Matching placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete ulcer healing at 6 months
Time Frame: Month 6
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
Time Frame: Month 12
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The percentage reduction of ulcer size from baseline
Time Frame: Months 4, 6, 8, 10, 12
Months 4, 6, 8, 10, 12
Hemodynamic measurements of toe pressure (TP)
Time Frame: Months 4, 6, 8, 10, 12
Measure of baseline and change from baseline for hemodynamic parameters
Months 4, 6, 8, 10, 12
Hemodynamic measurements of ankle systolic pressure (ASP)
Time Frame: Months 4, 6, 8, 10, 12
Measure of baseline and change from baseline for hemodynamic parameters
Months 4, 6, 8, 10, 12
Hemodynamic measurements of ankle brachial index (ABI)
Time Frame: Months 4, 6, 8, 10, 12
Measure of baseline and change from baseline for hemodynamic parameters
Months 4, 6, 8, 10, 12
Hemodynamic measurements of toe brachial index (TBI)
Time Frame: Months 4, 6, 8, 10, 12
Measure of baseline and change from baseline for hemodynamic parameters
Months 4, 6, 8, 10, 12
Hemodynamic measurements of TcPO2
Time Frame: Months 4, 6, 8, 10, 12
Measure of baseline and change from baseline for hemodynamic parameters
Months 4, 6, 8, 10, 12
Visual Analogue Scale (VAS)
Time Frame: Months 4, 6, 8, 10, 12
Measure of baseline and change from baseline for VAS. VAS is a 10-cm line (with score ranges 0 to 10), oriented horizontally; the left end of the line (0 mark) indicates "no pain"; the right end indicates "pain as bad as it can be."
Months 4, 6, 8, 10, 12
Occurrence of New Ulcer of the Index leg
Time Frame: Months 4, 6, 8, 10, 12
Number of subjects and proportions with new ulcer
Months 4, 6, 8, 10, 12
Major / Minor Amputations (digit, forefoot) / Revascularization of the Index Leg
Time Frame: Months 4, 6, 8, 10, 12
Number of subjects and proportions with major/minor amputation or revascularization
Months 4, 6, 8, 10, 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AnGes USA, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AG-CLTI-0211

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Sharing Supporting Information Type

  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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