Critical Limb IschemiaPhase 3AGILITYNCT02144610
Efficacy and Safety of AMG0001 in Subjects With Critical Limb Ischemia
A Phase 3 study testing HGF Plasmid (AMG0001) in people with Critical Limb Ischemia, run by AnGes USA, Inc. at 60 sites in 11 countries.
Trial summary
Study to Evaluate the Efficacy and Safety of AMG0001 in Subjects with Critical Limb Ischemia. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Critical Limb Ischemia
- What is being tested?
- HGF Plasmid (AMG0001)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 60 sitesin 11 countries
- Study dates
- 12 Nov 2014to 28 Nov 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with CLI (Severe Rutherford 4 and Rutherford 5) who have:
- No option for revascularization by endovascular intervention or surgical bypass
- or
- Poor option (high risk) for revascularization by surgery and no option for an endovascular intervention (see Section 3.1 Study Population for full definition for appropriate inclusions).
- Subjects 40-90 years of either gender who have signed an informed consent form either directly or through a legally authorized representative.
- Subjects currently are taking a statin and an anti-platelet agent (e.g., clopidogrel, ticlopidine, aspirin, etc.) for 2 weeks or more prior to Day 0 as part of their standard of care, unless contraindicated. Subjects for whom these agents are contraindicated will have the reason for contraindication recorded in their case report form (CRF).
Show all 12Show fewer
- If female, the subjects must not be of child bearing potential, e.g., post-menopausal or surgically sterile.
- If a male subject is of reproductive potential, he must agree to use an accepted and effective (barrier) form of birth control starting with the first dose of study product and continue for 12 weeks from the last dose of study product. This applies to both courses of treatment.
- Subjects with a previous medical history of myocardial infarction and/or stroke should have adequate management of risk factors to prevent secondary occurrence. (See Section 4.2 Medical History for guidelines on appropriate secondary prevention.)
- Subjects should have the ability to understand the requirements of the protocol and agree to return for the required study visits, assessments and follow up.
- The index leg will be the leg with the greater severity of CLI disease. Entry requirements apply to the index leg. The index leg may also be referred to as the treated leg or affected leg in the text of this protocol or other study documents. If the subject has two legs that have the same Rutherford classification (severe Rutherford 4 or Rutherford 5) and are both eligible for treatment, the leg with greater disease severity (based on more extensive necrosis or more extensive/deeper ulceration(s), difference in ABI (ankle brachial index) or TBI (toe brachial index) ≥ 0.1, and/or more extensive vascular disease based on the angiogram) will be chosen as the index leg. If there is no clinical, hemodynamic or angiographic or other evidence to determine which leg has greater disease severity, the subject will be excluded from the study.
- These entry criteria will be enforced (prior to randomization) by the Sponsor, as well as an Entry Committee who will review all relevant clinical data including but not limited to medical illness, CLI status, the findings of an angiogram, ulcer photographs and measurements and hemodynamic data.
Who cannot join
- Subjects whose CLI status is unstable (spontaneous marked improvement or marked worsening during the screening period) or who have excessive tissue necrosis that is unlikely to benefit from medication, or those poor option subjects requiring immediate revascularization by surgery. Stability of the CLI status will be confirmed by the Principal Investigator prior to randomization and retrospectively reviewed by the Adjudication Committee.
- Subjects who may require a major amputation (amputation at or above the ankle) within 4 weeks of Day 0 (± 4 weeks of Day 0).
- Subjects with ulcers with exposure of tendons, osteomyelitis or uncontrolled infection or with the largest ulcer that is greater than 20 cm2 in area (>10 cm2 area if on the heel).
- Subjects with purely neuropathic, or with venous ulcers.
- Subjects in Rutherford 6 class.
- Subjects who have had revascularization by surgery or angioplasty within 3 months, unless the procedure has failed based on the anatomy or the hemodynamic measurements.
Show all 20Show fewer
- Subjects with a diagnosis of Buerger's disease (Thrombo-angiitis Obliterans).
- Subjects currently receiving immunosuppressive, chemo or radiation therapy.
- Evidence or history of malignant neoplasm (clinical, laboratory or imaging) except for successfully excised basal cell or squamous cell carcinoma, or successfully excised early melanoma of the skin. Subjects, who had successful tumor resection or radio-chemotherapy of breast cancer more than 10 years prior to inclusion in the study, and with no recurrence, may be enrolled in the study. Subjects, who had successful tumor resection or radio-chemotherapy of all other tumor types and have been in remission for more than 5 years prior to inclusion in the study, and with no recurrence, may be enrolled in the study. A dermatological exam will have ruled out any skin cancer.
- Subjects who have proliferative retinopathy, or moderate or severe non-proliferative retinopathy, from any cause (ETDRS Score > 35), clinically significant macular oedema or previous panretinal photocoagulation therapy (Results from the Early Treatment Diabetic Retinopathy Study. Ophthalmology May 1991 Supplement 98: 823-833).
- Females of child-bearing potential defined as subjects that are not surgically sterile or post-menopausal.
- Subjects with severe renal disease defined as significant renal dysfunction evidenced by an estimated creatinine clearance of <30 mL/minute (calculated using the Cockcroft Gault formula), or receiving chronic hemodialysis therapy.
- Any co-morbid condition likely to interfere with assessment of safety or efficacy endpoints, acute cardiovascular events (i.e., CVA (cardiovascular accident), MI (myocardial infarction), etc.) within 3 months of treatment, or any disease that in the opinion of the Investigator may result in subject mortality in less than 3 months.
- Subjects with known liver disease (e.g., hepatitis B or C or cirrhosis of the liver).
- A subject with HIV, AIDS, severe uncontrolled inflammatory disease or severe uncontrolled autoimmune disease (e.g., ulcerative colitis, Crohn's disease, etc).
- Subjects who have a significant psychiatric disorder or mental disability that could interfere with the subject's ability to provide informed consent or comply with study procedures.
- Subjects with a current, uncorrected history of alcohol or substance abuse.
- Diabetic subjects with an uncorrected HbA1c > 9.0% during the screening period.
- Subjects that have been administered rhPDGF (e.g, becaplermin) or other growth factors locally within one month of randomization.
- Subjects who have received another investigational drug within 30 days of randomization or have previously received any gene transfer therapy within 3 years of entering the study.
Trial locations and contacts
60 sites in 11 countries.
60 sites in 11 countries
United States28 sites
Emory University
Atlanta, Georgia, 30322
Boston University School of Medicine
Boston, Massachusetts, 02118
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Medical University of South Carolina
Charleston, South Carolina, 29425
Northwestern University
Chicago, Illinois, 60611
University of Florida
Gainesville, Florida, 32610
The Methodist Hospital Research Institute
Houston, Texas, 77030
Saint Luke's Hospital
Kansas City, Missouri, 64111
Kansas City Vascular P.C.
Kansas City, Missouri, 64116
University of California, San Diego (UCSD)
La Jolla, California, 92037-1300
Alliance Research Centers
Laguna Hills, California, 92653
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Central Arkansas Veteran's Healthcare System
Little Rock, Arkansas, 72205
New York Presbyterian Hospital - Columbia University Medical Center
New York, New York, 10032
Veterans Affairs Medical Center
Pittsburgh, Pennsylvania, 15240
Oregon Health and Science University
Portland, Oregon, 97239
Harbin Clinic, LLC
Rome, Georgia, 30165
Peninsula Region Medical Center
Salisbury, Maryland, 21801
San Francisco Veterans Affairs Medical Center
San Francisco, California, 94121
Sarasota Memorial Hospital Clinical Research Center
Sarasota, Florida, 34239
Sanford Health
Sioux Falls, South Dakota, 57104
Mercy Medical Research Institute
Springfield, Missouri, 65806
Mercy Hospital St. Louis
St Louis, Missouri, 63141
Holy Name Medical Center
Teaneck, New Jersey, 07666
Carondelet Heart and Vascular Institute
Tucson, Arizona, 85745
University of Oklahoma - Physicians Surgical Specialists
Tulsa, Oklahoma, 74104
Northwestern Medicine Central DuPage Hospital
Winfield, Illinois, 60190
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
Hungary11 sites
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, 1134
Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika
Debrecen, 4032
Petz Aladar Megyei Oktato Korhaz
Győr, 9024
Bekes Megyei Pandy Kalman Korhaz Ersebeszet
Gyula, 5700
Bekes Megyei Pandy Kalman Korhaz
Gyula
Somogy Megyei Kaposi Mor Oktato Korhaz Altalanos- Mellkas es Ersebeszeti Osztaly
Kaposvár, 7400
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc, 3526
SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, 4400
Pecsi Tudomanyegyetem AOK
Pécs, 7623
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinika Központ
Szeged, 6720
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz
Székesfehérvár, 8000
Finland4 sites
Helsinki University Hospital
Helsinki, 00290
Kuopio University Hospital
Kuopio, 70029
Kuopio University Hospital
Kuopio, 70210
Tampere University Hospital
Tampere, 33520
France4 sites
CHU Amiens - Groupe Hospitalier Hopital Sud
Amiens, 80054
Hôpital Saint André
Bordeaux, 33075
CHU de Grenoble - Hôpital Albert Michallon
Grenoble, 38043
Hopital Cardiologique - CHU Lille
Lille, Nord, 59037
Belgium3 sites
Antwerpen University Hospital
Edegem, 2650
Ziekenhuis Oost Limburg
Genk, 3600
Universitair Ziekenhuis Gent
Ghent, 9000
Netherlands3 sites
Leiden Universitair Medisch Centrum
Leiden, 2333 ZA
Maastricht University Medical Center
Maastricht, 6229 HX
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
Poland3 sites
Szpital Uniwersytecki nr 1 im. Dr A. Jurasza w Bydgoszczy
Bydgoszcz, 85-094
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-952
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
Poznan, 61-848
Sweden1 site
Karlkirurgiska Kliniken, Karolinska Universitetssjukhuset
Stockholm, 171 76
About this study
Official title: A Phase 3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AMG0001 in Subjects With Critical Limb Ischemia
Study to Evaluate the Efficacy and Safety of AMG0001 in Subjects with Critical Limb Ischemia.
Read the detailed description
This is a double-blind, randomized, placebo-controlled, phase 3, multinational, multicenter study of AMG0001 (HGF plasmid) in subjects with Critical Limb Ischemia (CLI).
- Conditions
- Critical Limb Ischemia
- Being tested
- HGF Plasmid (AMG0001), Matching Placebo
- Keywords
- CLI
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HGF Plasmid (AMG0001)Biological
Also called Beperminogene perplasmid (INN)
IM
Matching PlaceboBiological
IM
| Study group | Role | What they receive |
|---|---|---|
| Gene Therapy HGF Plasmid (AMG0001) | Experimental | Randomized subjects will receive 4 sets of intramuscular (IM) injections of HGF plasmid two weeks apart starting at Day 0 and again at Month 3 (first cycle) and at Month 9 and again at Month 12 (second cycle) in muscles of the affected lower limb. Receives: Biological: HGF Plasmid (AMG0001) |
| Placebo | Placebo comparator | Randomized subjects will receive 4 sets of intramuscular (IM) injections of matching placebo two weeks apart starting at Day 0 and again at Month 3 (first cycle) and at Month 9 and again at Month 12 (second cycle) in muscles of the affected lower limb. Receives: Biological: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Amputation or Revascularization (of the Index Leg), All-cause Death, and Incidence of Stroke and Myocardial Infarction (MI)
A frequency table for Day 0 to 6 months, Day 0 to 12 months and Day 0 to 18 months intervals by treatment group; the Fisher's Exact test was used for treatment comparison.
Measured: 18 months
Change in Ischemic Rest Pain (in the Index Leg) From Baseline Using a 10 cm Visual Analog Scale (VAS) Scale
The severity of rest pain (based on the average over previous 7 days) recorded using the 10 cm visual analog scale (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."
- The subject is asked to mark a place on the line corresponding to the average pain intensity experienced in the last 7 days.
- The distance along the scale is converted into a numeric reading by measuring the distance of the subjects mark in cm from the beginning of the scale (the 0 mark).
Measured: 18 months
Ulcer Improvement
A table showing the number of subjects with complete healing of the target ulcer by treatment. Ulcer healing of the largest ulcer on the index limb was assessed clinically by the Principal Investigator by direct visual inspection at each study visit. If the largest ulcer on the index leg was considered completely healed, photographs of the healed ulcer area was captured. If an ulcer healed completely during the study period, the ulcer was re-evaluated 2 weeks later to confirm it has remained healed. Confirmation of complete ulcer healing was made by an outside physician unconnected with the study and nominated for this purpose.
Measured: 18 months
VAS Improvement
A table showing the number of subjects with improvement in VAS (≥ 20 mm) by treatment.
Measured: 18 months
Hemodynamic Measurements - Mean Change From Baseline in Brachial (Right/Left) Systolic Pressure
Summary statistics were provided for baseline and change from baseline for right/left brachial systolic pressure by visit and treatment (only subjects with non-missing baseline and visit values). A two-way analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate were performed for each visit and LOCF.
Measured: 18 months
Hemodynamic Measurements - Mean Change From Baseline in Ankle (Dorsalis Pedis/Posterior Tibial) Systolic Pressure
Summary statistics were provided for baseline and change from baseline for ankle systolic pressure measured at dorsalis pedis and posterior tibial by visit and treatment (only subjects with non-missing baseline and visit values). A two-way analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate were performed for each visit and LOCF.
Measured: 18 months
Hemodynamic Measurements - Mean Change From Baseline in Toe Systolic Pressure
Summary statistics were provided for baseline and change from baseline for toe systolic pressure by visit and treatment (only subjects with non-missing baseline and visit values). A two-way analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate were performed for each visit and LOCF.
Measured: 18 months
Hemodynamic Measurements - Mean Change From Baseline in ABI of Index Leg
Summary statistics were provided for baseline and change from baseline for calculated ABI by visit and treatment (only subjects with non-missing baseline and visit values). A two-way analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate were performed for each visit and LOCF.
Measured: 18 months
Hemodynamic Measurements - Mean Change From Baseline in TBI of Index Leg
Summary statistics were provided for baseline and change from baseline for calculated TBI by visit and treatment (only subjects with non-missing baseline and visit values). A two-way analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate were performed for each visit and LOCF.
Measured: 18 months
Changes in the Quality of Life Using the Vascular Quality of Life Questionnaire (VascuQol) Over 18 Months
The VascuQol contains 5 domains (pain, symptom, activities, social, and emotional functioning); responses were scored from 0 (lowest QOL, death) to 7 (best QOL, maximum health).
Responses were averaged for composite overall and domain-specific scores, giving equal weight to each question and domain. The composite overall is the average of domain-specific scores.
Responses after revascularization or major amputation were included in the analysis. In the event of death, subjects were scored as 0. For the effect of treatment on individual domains, pain, symptoms, and activities were considered the most important of the 5 domains.
Summary statistics were provided for baseline and change from baseline by visit and treatment for VascuQol, including subscore, for subjects who had a non-missing value at both baseline and the specific visit. A two-way ANCOVA with treatment and region as fixed factors and baseline as a covariate were performed for each visit and LOCF.
Measured: 18 months
Changes in the Quality of Life From Baseline Using the EQ-5D-5L Over 18 Months
The EQ-5D-5L descriptive system covers 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5); death was coded as a worst case.
The EQ-5D-5L health state for each subject, referred to as a 5 digit code that combines 1 level from each of the 5 dimensions, was converted into a single index value using a published weighing system. The index value ranges from -0.109 to 1, where 1 indicates no problems in all 5 dimensions, and is reduced when a patient reports increasing problems.
Summary statistics were provided for baseline and change from baseline by visit and treatment for EQ-5D-5L, including subscore, for subjects who had a non-missing value at both baseline and the specific visit. A two-way ANCOVA with treatment and region as fixed factors and baseline as a covariate were performed for each visit and LOCF.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2014 (estimated)
- Study start12 Nov 2014
- Primary completion28 Nov 2016
- Study completion28 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Critical Limb IschemiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- AnGes USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard J. Powell, MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144610
- Sponsor's protocol ID
- AG-CLI-0206
- Other IDs
- 2014-001129-34, 2014
- Acronym
- AGILITY
- Status last verified
- Jul 2019
- First submitted
- 20 May 2014
- Last updated
- 13 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AMG0001 in Subjects With Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT02144610
- Acronym / sponsor ID
- AGILITY / AG-CLI-0206
- Conditions
- Critical Limb Ischemia
- Keywords
- CLI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 46 participants (actual)
- Lead sponsor
- AnGes USA, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Nov 2014 (actual)
- Primary completion
- 28 Nov 2016 (actual)
- Study completion
- 28 Nov 2016 (actual)
- First posted
- 22 May 2014 (estimated)
- Results
- Posted 13 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to Evaluate the Efficacy and Safety of AMG0001 in Subjects with Critical Limb Ischemia.
Detailed description
This is a double-blind, randomized, placebo-controlled, phase 3, multinational, multicenter study of AMG0001 (HGF plasmid) in subjects with Critical Limb Ischemia (CLI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gene Therapy HGF Plasmid (AMG0001) | Experimental | Biological: HGF Plasmid (AMG0001)Randomized subjects will receive 4 sets of intramuscular (IM) injections of HGF plasmid two weeks apart starting at Day 0 and again at Month 3 (first cycle) and at Month 9 and again at Month 12 (second cycle) in muscles of the affected lower limb. |
| Placebo | Placebo comparator | Biological: Matching PlaceboRandomized subjects will receive 4 sets of intramuscular (IM) injections of matching placebo two weeks apart starting at Day 0 and again at Month 3 (first cycle) and at Month 9 and again at Month 12 (second cycle) in muscles of the affected lower limb. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subjects with CLI (Severe Rutherford 4 and Rutherford 5) who have:
- or
- Subjects 40-90 years of either gender who have signed an informed consent form either directly or through a legally authorized representative.
- Subjects currently are taking a statin and an anti-platelet agent (e.g., clopidogrel, ticlopidine, aspirin, etc.) for 2 weeks or more prior to Day 0 as part of their standard of care, unless contraindicated. Subjects for whom these agents are contraindicated will have the reason for contraindication recorded in their case report form (CRF).
- If female, the subjects must not be of child bearing potential, e.g., post-menopausal or surgically sterile.
Key exclusion criteria (20 listed)
- Subjects whose CLI status is unstable (spontaneous marked improvement or marked worsening during the screening period) or who have excessive tissue necrosis that is unlikely to benefit from medication, or those poor option subjects requiring immediate revascularization by surgery. Stability of the CLI status will be confirmed by the Principal Investigator prior to randomization and retrospectively reviewed by the Adjudication Committee.
- Subjects who may require a major amputation (amputation at or above the ankle) within 4 weeks of Day 0 (± 4 weeks of Day 0).
- Subjects with ulcers with exposure of tendons, osteomyelitis or uncontrolled infection or with the largest ulcer that is greater than 20 cm2 in area (>10 cm2 area if on the heel).
- Subjects with purely neuropathic, or with venous ulcers.
- Subjects in Rutherford 6 class.
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 |
|---|---|---|
| HGF Plasmid (AMG0001)Also: Beperminogene perplasmid (INN)IM | Biological | Gene Therapy HGF Plasmid (AMG0001) |
| Matching PlaceboIM | Biological | Placebo |
Primary outcome
Major Amputation or Revascularization (of the Index Leg), All-cause Death, and Incidence of Stroke and Myocardial Infarction (MI)
Time frame: 18 months
A frequency table for Day 0 to 6 months, Day 0 to 12 months and Day 0 to 18 months intervals by treatment group; the Fisher's Exact test was used for treatment comparison.
Change in Ischemic Rest Pain (in the Index Leg) From Baseline Using a 10 cm Visual Analog Scale (VAS) Scale
Time frame: 18 months
The severity of rest pain (based on the average over previous 7 days) recorded using the 10 cm visual analog scale (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." 1. The subject is asked to mark a place on the line corresponding to the average pain intensity experienced in the last 7 days. 2. The distance along the scale is converted into a numeric reading by measuring the distance of the subjects mark in cm from the beginning of the scale (the 0 mark).
Ulcer Improvement
Time frame: 18 months
A table showing the number of subjects with complete healing of the target ulcer by treatment. Ulcer healing of the largest ulcer on the index limb was assessed clinically by the Principal Investigator by direct visual inspection at each study visit. If the largest ulcer on the index leg was considered completely healed, photographs of the healed ulcer area was captured. If an ulcer healed completely during the study period, the ulcer was re-evaluated 2 weeks later to confirm it has remained healed. Confirmation of complete ulcer healing was made by an outside physician unconnected with the study and nominated for this purpose.
VAS Improvement
Time frame: 18 months
A table showing the number of subjects with improvement in VAS (≥ 20 mm) by treatment.
Hemodynamic Measurements - Mean Change From Baseline in Brachial (Right/Left) Systolic Pressure
Time frame: 18 months
Summary statistics were provided for baseline and change from baseline for right/left brachial systolic pressure by visit and treatment (only subjects with non-missing baseline and visit values). A two-way analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate were performed for each visit and LOCF.
Hemodynamic Measurements - Mean Change From Baseline in Ankle (Dorsalis Pedis/Posterior Tibial) Systolic Pressure
Time frame: 18 months
Summary statistics were provided for baseline and change from baseline for ankle systolic pressure measured at dorsalis pedis and posterior tibial by visit and treatment (only subjects with non-missing baseline and visit values). A two-way analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate were performed for each visit and LOCF.
Hemodynamic Measurements - Mean Change From Baseline in Toe Systolic Pressure
Time frame: 18 months
Summary statistics were provided for baseline and change from baseline for toe systolic pressure by visit and treatment (only subjects with non-missing baseline and visit values). A two-way analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate were performed for each visit and LOCF.
Hemodynamic Measurements - Mean Change From Baseline in ABI of Index Leg
Time frame: 18 months
Summary statistics were provided for baseline and change from baseline for calculated ABI by visit and treatment (only subjects with non-missing baseline and visit values). A two-way analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate were performed for each visit and LOCF.
Hemodynamic Measurements - Mean Change From Baseline in TBI of Index Leg
Time frame: 18 months
Summary statistics were provided for baseline and change from baseline for calculated TBI by visit and treatment (only subjects with non-missing baseline and visit values). A two-way analysis of covariance (ANCOVA) with treatment and region as fixed factors and baseline as a covariate were performed for each visit and LOCF.
Changes in the Quality of Life Using the Vascular Quality of Life Questionnaire (VascuQol) Over 18 Months
Time frame: 18 months
The VascuQol contains 5 domains (pain, symptom, activities, social, and emotional functioning); responses were scored from 0 (lowest QOL, death) to 7 (best QOL, maximum health). Responses were averaged for composite overall and domain-specific scores, giving equal weight to each question and domain. The composite overall is the average of domain-specific scores. Responses after revascularization or major amputation were included in the analysis. In the event of death, subjects were scored as 0. For the effect of treatment on individual domains, pain, symptoms, and activities were considered the most important of the 5 domains. Summary statistics were provided for baseline and change from baseline by visit and treatment for VascuQol, including subscore, for subjects who had a non-missing value at both baseline and the specific visit. A two-way ANCOVA with treatment and region as fixed factors and baseline as a covariate were performed for each visit and LOCF.
Changes in the Quality of Life From Baseline Using the EQ-5D-5L Over 18 Months
Time frame: 18 months
The EQ-5D-5L descriptive system covers 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4), and extreme problems (5); death was coded as a worst case. The EQ-5D-5L health state for each subject, referred to as a 5 digit code that combines 1 level from each of the 5 dimensions, was converted into a single index value using a published weighing system. The index value ranges from -0.109 to 1, where 1 indicates no problems in all 5 dimensions, and is reduced when a patient reports increasing problems. Summary statistics were provided for baseline and change from baseline by visit and treatment for EQ-5D-5L, including subscore, for subjects who had a non-missing value at both baseline and the specific visit. A two-way ANCOVA with treatment and region as fixed factors and baseline as a covariate were performed for each visit and LOCF.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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RecruitingObservational study
Vessel Recoil in Specific CLTI Populations
Chronic Limb Threatening Ischemia
Not yet recruiting
DCB Outcomes After Non-Compliant Balloon Vessel Preparation With or Without Scoring in Patients With Femoropopliteal Arterial Disease
Femoropopliteal Disease, Drug Coated Balloon
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.
Richard J. Powell, MD principal investigator
Dartmouth-Hitchcock Medical Center
60 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HGF Plasmid (AMG0001) in people with Critical Limb Ischemia, run by AnGes USA, Inc. at 60 sites in 11 countries.
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 12 inclusion and 20 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: stopped early, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Hungary, Finland, France, Belgium and 6 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Amputation or Revascularization (of the Index Leg), All-cause Death, and Incidence of Stroke and Myocardial Infarction (MI) (time frame: 18 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2019.