Back to resultsStudy of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers
Primary Purpose
Peripheral Artery Disease, Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease, Chronic Limb Threatening Ischemia
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AMG0001
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Artery Disease
Eligibility Criteria
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
Sites / Locations
- ILD Research CenterRecruiting
- Rancho Research InstituteRecruiting
- Limb Preservation Platform, Inc.Recruiting
- Felix Sigal, D.P.M. A Professional CorporationRecruiting
- Center for Clinical Research Inc.Recruiting
- University of California, San FranciscoRecruiting
- Goleta Valley Cottage HospitalRecruiting
- BRCR GlobalRecruiting
- Doctors Research NetworkRecruiting
- Barry University Clinical ResearchRecruiting
- Guardian Research/Florida CardiologyRecruiting
- Gateway Clinical Trials, LLCRecruiting
- Rosalind Franklin University Health ClinicsRecruiting
- Brigham and Women's Hospital / Harvard Medical SchoolRecruiting
- Advanced Foot & Ankle CenterRecruiting
- Vascular Solutions of North CarolinaRecruiting
- The Lindner Center for Research and Education at the Christ HospitalRecruiting
- Lower Extremity Institute for Research and Therapy (LEIRT)Recruiting
- Oregon Health & Sciences UniversityRecruiting
- Foot and Ankle Associates of Southwest VirginiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
AMG0001 4mg
AMG0001 8mg
Placebo
Arm Description
AMG0001 4mg + standard wound care
AMG0001 8mg + standard wound care
Placebo + standard wound care
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
The percentage reduction of ulcer size from baseline
Hemodynamic measurements of toe pressure (TP)
Measure of baseline and change from baseline for hemodynamic parameters
Hemodynamic measurements of ankle systolic pressure (ASP)
Measure of baseline and change from baseline for hemodynamic parameters
Hemodynamic measurements of ankle brachial index (ABI)
Measure of baseline and change from baseline for hemodynamic parameters
Hemodynamic measurements of toe brachial index (TBI)
Measure of baseline and change from baseline for hemodynamic parameters
Hemodynamic measurements of TcPO2
Measure of baseline and change from baseline for hemodynamic parameters
Visual Analogue Scale (VAS)
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."
Occurrence of New Ulcer of the Index leg
Number of subjects and proportions with new ulcer
Major / Minor Amputations (digit, forefoot) / Revascularization of the Index Leg
Number of subjects and proportions with major/minor amputation or revascularization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04267640
Brief Title
Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 30, 2020 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AnGes USA, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease, Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease, Chronic Limb Threatening Ischemia, Ischemic Ulcer of Foot
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AMG0001 4mg
Arm Type
Experimental
Arm Description
AMG0001 4mg + standard wound care
Arm Title
AMG0001 8mg
Arm Type
Experimental
Arm Description
AMG0001 8mg + standard wound care
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo + standard wound care
Intervention Type
Biological
Intervention Name(s)
AMG0001
Other Intervention Name(s)
HGF plasmid, Collategene, beperminogene perplasmid
Intervention Description
AMG0001 is a DNA Plasmid encoding hepatocyte growth factor (HGF) administered intramuscularly
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Matching placebo
Primary Outcome Measure Information:
Title
Complete ulcer healing at 6 months
Description
Complete ulcer healing defined as skin re-epithelialization without drainage or dressing requirements confirmed at 2 consecutive study visits 2 weeks apart.
Time Frame
Month 6
Title
Time to complete ulcer healing
Description
Complete ulcer healing defined as skin re-epithelialization without drainage or dressing requirements confirmed at 2 consecutive study visits 2 weeks apart.
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
The percentage reduction of ulcer size from baseline
Time Frame
Months 4, 6, 8, 10, 12
Title
Hemodynamic measurements of toe pressure (TP)
Description
Measure of baseline and change from baseline for hemodynamic parameters
Time Frame
Months 4, 6, 8, 10, 12
Title
Hemodynamic measurements of ankle systolic pressure (ASP)
Description
Measure of baseline and change from baseline for hemodynamic parameters
Time Frame
Months 4, 6, 8, 10, 12
Title
Hemodynamic measurements of ankle brachial index (ABI)
Description
Measure of baseline and change from baseline for hemodynamic parameters
Time Frame
Months 4, 6, 8, 10, 12
Title
Hemodynamic measurements of toe brachial index (TBI)
Description
Measure of baseline and change from baseline for hemodynamic parameters
Time Frame
Months 4, 6, 8, 10, 12
Title
Hemodynamic measurements of TcPO2
Description
Measure of baseline and change from baseline for hemodynamic parameters
Time Frame
Months 4, 6, 8, 10, 12
Title
Visual Analogue Scale (VAS)
Description
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."
Time Frame
Months 4, 6, 8, 10, 12
Title
Occurrence of New Ulcer of the Index leg
Description
Number of subjects and proportions with new ulcer
Time Frame
Months 4, 6, 8, 10, 12
Title
Major / Minor Amputations (digit, forefoot) / Revascularization of the Index Leg
Description
Number of subjects and proportions with major/minor amputation or revascularization
Time Frame
Months 4, 6, 8, 10, 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melton Affrime, PharmD
Phone
+1 908-444-3889
Email
maffrime@anges.co.jp
First Name & Middle Initial & Last Name or Official Title & Degree
Chan Quach
Phone
+1 240-780-9033
Email
cquach@anges-usa.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David G Armstrong, MD, DPM, PhD
Organizational Affiliation
Keck School of Medicine, USC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael S Conte, MD
Organizational Affiliation
Division of Vascular and Endovascular Surgery, UCSF
Official's Role
Principal Investigator
Facility Information:
Facility Name
ILD Research Center
City
Carlsbad
State/Province
California
ZIP/Postal Code
92009
Country
United States
Individual Site Status
Recruiting
Facility Name
Rancho Research Institute
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Individual Site Status
Recruiting
Facility Name
Limb Preservation Platform, Inc.
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Individual Site Status
Recruiting
Facility Name
Felix Sigal, D.P.M. A Professional Corporation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90026
Country
United States
Individual Site Status
Recruiting
Facility Name
Center for Clinical Research Inc.
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Name
Goleta Valley Cottage Hospital
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93111
Country
United States
Individual Site Status
Recruiting
Facility Name
BRCR Global
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33442
Country
United States
Individual Site Status
Recruiting
Facility Name
Doctors Research Network
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Individual Site Status
Recruiting
Facility Name
Barry University Clinical Research
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Individual Site Status
Recruiting
Facility Name
Guardian Research/Florida Cardiology
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32792
Country
United States
Individual Site Status
Recruiting
Facility Name
Gateway Clinical Trials, LLC
City
Belleville
State/Province
Illinois
ZIP/Postal Code
62226
Country
United States
Individual Site Status
Recruiting
Facility Name
Rosalind Franklin University Health Clinics
City
North Chicago
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
Individual Site Status
Recruiting
Facility Name
Brigham and Women's Hospital / Harvard Medical School
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Foot & Ankle Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Individual Site Status
Recruiting
Facility Name
Vascular Solutions of North Carolina
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Individual Site Status
Recruiting
Facility Name
The Lindner Center for Research and Education at the Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Name
Lower Extremity Institute for Research and Therapy (LEIRT)
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Individual Site Status
Recruiting
Facility Name
Oregon Health & Sciences University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Name
Foot and Ankle Associates of Southwest Virginia
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers
We'll reach out to this number within 24 hrs