Peripheral Artery DiseasePhase 2NCT04267640
Study of AMG0001 to Improve Ulcer Healing and Perfusion in Subjects With Peripheral Ischemic Ulcers
A Phase 2 study testing AMG0001 in people with Peripheral Artery Disease and Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease, run by AnGes USA, Inc. at 20 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease, Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease, Chronic Limb Threatening Ischemia
- What is being tested?
- AMG0001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 20 sitesUnited States
- Study dates
- 30 Jan 2020to Jan 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites, 20 recruiting
- Recruiting
Gateway Clinical Trials, LLC
Belleville, Illinois, 62226
- Recruiting
Brigham and Women's Hospital / Harvard Medical School
Boston, Massachusetts, 02115
- Recruiting
ILD Research Center
Carlsbad, California, 92009
- Recruiting
Vascular Solutions of North Carolina
Cary, North Carolina, 27518
- Recruiting
The Lindner Center for Research and Education at the Christ Hospital
Cincinnati, Ohio, 45219
- Recruiting
BRCR Global
Deerfield Beach, Florida, 33442
- Recruiting
Rancho Research Institute
Downey, California, 90242
- Recruiting
Limb Preservation Platform, Inc.
Fresno, California, 93710
- Recruiting
Advanced Foot & Ankle Center
Las Vegas, Nevada, 89119
- Recruiting
Felix Sigal, D.P.M. A Professional Corporation
Los Angeles, California, 90026
- Recruiting
Rosalind Franklin University Health Clinics
North Chicago, Illinois, 60064
- Recruiting
Oregon Health & Sciences University
Portland, Oregon, 97239
- Recruiting
Foot and Ankle Associates of Southwest Virginia
Salem, Virginia, 24153
- Recruiting
Center for Clinical Research Inc.
San Francisco, California, 94117
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
- Recruiting
Goleta Valley Cottage Hospital
Santa Barbara, California, 93111
- Recruiting
Doctors Research Network
South Miami, Florida, 33143
- Recruiting
Barry University Clinical Research
Tamarac, Florida, 33321
- Recruiting
Guardian Research/Florida Cardiology
Winter Park, Florida, 32792
- Recruiting
Lower Extremity Institute for Research and Therapy (LEIRT)
Youngstown, Ohio, 44512
About this study
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
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.
Read the 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)
- Conditions
- Peripheral Artery Disease, Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease, Chronic Limb Threatening Ischemia, Ischemic Ulcer of Foot
- Being tested
- AMG0001, Placebo
- Medical subject headings
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG0001Biological
Also called HGF plasmid, Collategene, beperminogene perplasmid
AMG0001 is a DNA Plasmid encoding hepatocyte growth factor (HGF) administered intramuscularly
PlaceboBiological
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| AMG0001 4mg | Experimental | AMG0001 4mg + standard wound care Receives: Biological: AMG0001 |
| AMG0001 8mg | Experimental | AMG0001 8mg + standard wound care Receives: Biological: AMG0001 |
| Placebo | Placebo comparator | Placebo + standard wound care Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Month 12
Secondary outcomes (9)
The percentage reduction of ulcer size from baseline
Measured: Months 4, 6, 8, 10, 12
Hemodynamic measurements of toe pressure (TP)
Measure of baseline and change from baseline for hemodynamic parameters
Measured: Months 4, 6, 8, 10, 12
Hemodynamic measurements of ankle systolic pressure (ASP)
Measure of baseline and change from baseline for hemodynamic parameters
Measured: Months 4, 6, 8, 10, 12
Hemodynamic measurements of ankle brachial index (ABI)
Measure of baseline and change from baseline for hemodynamic parameters
Measured: Months 4, 6, 8, 10, 12
Hemodynamic measurements of toe brachial index (TBI)
Measure of baseline and change from baseline for hemodynamic parameters
Measured: Months 4, 6, 8, 10, 12
Hemodynamic measurements of TcPO2
Measure of baseline and change from baseline for hemodynamic parameters
Measured: Months 4, 6, 8, 10, 12
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."
Measured: Months 4, 6, 8, 10, 12
Occurrence of New Ulcer of the Index leg
Number of subjects and proportions with new ulcer
Measured: Months 4, 6, 8, 10, 12
Major / Minor Amputations (digit, forefoot) / Revascularization of the Index Leg
Number of subjects and proportions with major/minor amputation or revascularization
Measured: Months 4, 6, 8, 10, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start30 Jan 2020
- Primary completionJul 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AnGes USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David G Armstrong, MD, DPM, PhD, Principal investigator, Keck School of Medicine USCMichael S Conte, MD, Principal investigator, Division of Vascular and Endovascular Surgery, UCSF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04267640
- Sponsor's protocol ID
- AG-CLTI-0211
- Status last verified
- Dec 2021
- First submitted
- 7 Feb 2020
- Last updated
- 22 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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. 2026 Jan;19(1):e015648. doi: 10.1161/CIRCINTERVENTIONS.125.015648. Epub 2025 Nov 4.
PubMed 41186002
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04267640
- Acronym / sponsor ID
- AG-CLTI-0211
- Conditions
- Peripheral Artery Disease, Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease, Chronic Limb Threatening Ischemia, Ischemic Ulcer of Foot
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- AnGes USA, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2020 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 13 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AMG0001 4mg | Experimental | Biological: AMG0001AMG0001 4mg + standard wound care |
| AMG0001 8mg | Experimental | Biological: AMG0001AMG0001 8mg + standard wound care |
| Placebo | Placebo comparator | Biological: PlaceboPlacebo + standard wound care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG0001Also: HGF plasmid, Collategene, beperminogene perplasmidAMG0001 is a DNA Plasmid encoding hepatocyte growth factor (HGF) administered intramuscularly | Biological | AMG0001 4mg, AMG0001 8mg |
| PlaceboMatching placebo | Biological | Placebo |
Primary outcome
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.
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.
9 secondary outcomes
The percentage reduction of ulcer size from baseline
Time frame: Months 4, 6, 8, 10, 12
Hemodynamic measurements of toe pressure (TP)
Time frame: Months 4, 6, 8, 10, 12
Hemodynamic measurements of ankle systolic pressure (ASP)
Time frame: Months 4, 6, 8, 10, 12
Hemodynamic measurements of ankle brachial index (ABI)
Time frame: Months 4, 6, 8, 10, 12
Hemodynamic measurements of toe brachial index (TBI)
Time frame: Months 4, 6, 8, 10, 12
Hemodynamic measurements of TcPO2
Time frame: Months 4, 6, 8, 10, 12
Visual Analogue Scale (VAS)
Time frame: Months 4, 6, 8, 10, 12
Occurrence of New Ulcer of the Index leg
Time frame: Months 4, 6, 8, 10, 12
Major / Minor Amputations (digit, forefoot) / Revascularization of the Index Leg
Time frame: Months 4, 6, 8, 10, 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Derived from this study: PubMed 41186002Armstrong 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. 2026 Jan;19(1):e015648. doi: 10.1161/CIRCINTERVENTIONS.125.015648. Epub 2025 Nov 4.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David G Armstrong, MD, DPM, PhD principal investigator
Keck School of Medicine USC
Michael S Conte, MD principal investigator
Division of Vascular and Endovascular Surgery, UCSF
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMG0001 in people with Peripheral Artery Disease and Ischaemic Ulcer of Lower Leg Due to Atherosclerotic Disease, run by AnGes USA, Inc. at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melton Affrime, PharmD (+1 908-444-3889, maffrime@anges.co.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete ulcer healing at 6 months (time frame: Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04267640, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.