Critical Limb Ischemia, Peripheral Arterial Disease, Vascular Diseases
Conditions
Keywords
Peripheral Arterial Disease, Vascular Disease, CLI, Critical Limb Ischemia, PAD, AnGes, HGF Plasmid, HGF, Hepatocyte Growth Factor Plasmid, gene therapy
Brief summary
The purpose of the study is to confirm the feasibility of study procedures and the tolerability of a new dose regimen of AMG0001 in subjects with Critical Limb Ischemia (CLI)
Detailed description
The primary objectives of the study are: 1. To confirm the feasibility of study-related activities and the tolerability of a modified dosage regimen of AMG0001 in CLI 2. To evaluate safety of AMG0001
Interventions
BIOLOGICALHGF Plasmid
Intramuscular injection in the affected limb.
Sponsors
AnGes USA, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Subjects with stable CLI (Severe Rutherford 4 and Rutherford 5) who have no option for revascularization by endovascular intervention or surgical bypass or a poor option (high risk) for revascularization by surgery and no option for an endovascular intervention * Subjects 40-90 years of either gender who have signed an informed consent * Subjects currently are taking a statin and an anti-platelet agent * 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. * Subjects with a previous medical history of myocardial infarction and/or stroke should have adequate management of risk factors to prevent secondary occurrence. * Subjects should have the ability to understand the requirements of the protocol and agree to return for the required study visits and assessments
Exclusion criteria
* Subjects whose CLI status is unstable (spontaneous marked improvement or marked worsening during the screening period). * 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 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. * 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. * 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. * A Stroke, TIA or MI within 3 months of entry into the study. * Subjects with known liver disease (e.g., hepatitis B or C or cirrhosis of the liver). * A subject with HIV, AIDS, or severe uncontrolled ulcerative colitis or Crohn's disease. * Subjects with a current, uncorrected history of alcohol or substance abuse. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) Suspected to be Related to Injections of AMG0001 | 18 months | All summaries and analyses will be presented in tabular or graphical form. The study is not powered for the statistical inference and the test will be considered to be descriptive. Treatment-emergent adverse events (TEAEs) was evaluated, and a table showing the number and percentage of subjects with occurrences categorized by System Organ Class and Preferred Term was provided by causality (relationship to study drug). |
| Number of Participants Discontinued Due to AEs From the Injections of AMG0001 | up to 18 Months | All summaries and analyses will be presented in tabular or graphical form. The study is not powered for the statistical inference and the test will be considered to be descriptive. Treatment-emergent adverse events (TEAEs) was evaluated, and a table showing the number and percentage of subjects with occurrences categorized by System Organ Class and Preferred Term was provided by whether the AE led to discontinuation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline of VascuQol Score for the Index Limb by Visit | 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. |
| Change in Hemodynamic Measurements of Change From Baseline Value of Toe Systolic Pressure (mmHg) | 18 months | Summary statistics was provided for baseline and change from baseline for toe systolic pressure by visit. At each visit, only subjects who have a non-missing value at both baseline and the specific visit was summarized. Two-sided one-sample t-test was performed for each visit and last observation carried forward (LOCF). |
| Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit | 18 months | Summary statistics was provided for baseline and change from baseline for ankle systolic pressure by visit. At each visit, only subjects who have a non-missing value at both baseline and the specific visit was summarized. Two-sided one-sample t-test was performed for each visit and last observation carried forward (LOCF). |
| Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg) | 18 months | Summary statistics was provided for baseline and change from baseline for right/left brachial systolic pressure by visit. At each visit, only subjects who have a non-missing value at both baseline and the specific visit was summarized. Two-sided one-sample t-test was performed for each visit and last observation carried forward (LOCF). |
| Number of Participants in Whom the Largest Ulcer Healed Completely or Gets Smaller (Photo Confirmation) | 18 Months | All summaries and analyses will be presented in tabular or graphical form. The study is not powered for the statistical inference and the test will be considered to be descriptive. A table showing the number of subjects completely healed in the target ulcer was provided at up to 6 months, \> 6 months to 12 months, from \>12 months to 18 months. |
| Change in Hemodynamic Measurement of Baseline Calculated ABI of the Index Leg by Visit | 18 months | Summary statistics was provided for baseline and change from baseline for ankle brachial index (ABI) by visit. At each visit, only subjects who have a non-missing value at both baseline and the specific visit was summarized. Two-sided one-sample t-test was performed for each visit and last observation carried forward (LOCF). ABI was calculated by dividing the ankle systolic blood pressure by the brachial systolic blood pressure. ABI was calculated at baseline and at each visit. The change in ABI at each visit compared to the baseline value was recorded. |
| Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death | 18 months | A summary table including counts and percentages was provided for subjects who had MI, stroke, major amputation, revascularization, or all-cause death for the time periods: 0 to Month 6, 0 to Month 12, 0 to Month 18. |
| Number of Participants With Worsening CLI Event of Index Leg | 18 months | A summary table and listing of worsening CLI-related events of the index leg including any new or worsening events, worsening rest pain, new ulcer or worsening ulcer, new or worsening wound infection, peripheral vascular intervention, complication of a peripheral vascular intervention, cellulitis, and amputation due to worsening CLI was provided. |
| Number of Participants With Shift From Baseline in Rutherford Classification | 18 months | Shift from baseline in Rutherford classification was summarized by study visit. Patients enrolled in the study were classified as either Rutherford 4 or Rutherford 5 at baseline. Rutherford category (clinical description) 0 (Asymptomatic - no hemodynamically significant occlusive disease) 1. (Mild claudication) 2. (Moderate claudication) 3. (Severe claudication) 4. (Ischemic rest pain) 5. (Minor tissue loss - nonhealing ulcer, focal gangrene with diffuse pedal ischemia) 6. (Major tissue loss - extending above TM level, functional foot no longer salvageable) |
| Change in Hemodynamic Measurement of Baseline Calculated Toe Brachial Index (TBI) of the Index Leg by Visit | 18 months | Summary statistics was provided for baseline and change from baseline for toe brachial index (TBI) by visit. At each visit, only subjects who have a non-missing value at both baseline and the specific visit was summarized. Two-sided one-sample t-test was performed for each visit and last observation carried forward (LOCF). TBI was calculated by dividing the toe systolic blood pressure by the brachial systolic blood pressure. TBI was calculated at baseline and at each visit. The change in TBI at each visit compared to the baseline value was recorded. |
| Number of Participants in Whom Rest Pain (Based on 10 cm VAS Scale) Reduces by 20 mm (2 cm) or More or Was Completely Relieved. | 18 months | All summaries and analyses will be presented in tabular or graphical form. The study is not powered for the statistical inference and the test will be considered to be descriptive. 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). |
Countries
United States
Participant flow
Recruitment details
10 subjects were enrolled at a single clinical site.
Participants by arm
| Arm | Count |
|---|---|
| AMG0001 Hepatocyte Growth Factor (HGF) Plasmid
HGF Plasmid: Intramuscular injection in the affected limb. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Death | 2 |
| Overall Study | Major amputation of index limb | 2 |
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | AMG0001 |
|---|---|
| Ability to Self-care Missing | 1 Participants |
| Ability to Self-care None | 5 Participants |
| Ability to Self-care Some | 4 Participants |
| Ability to Self-care Unable | 0 Participants |
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 6 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 68.4 years STANDARD_DEVIATION 5.8 |
| Alcohol Use No | 4 Participants |
| Alcohol Use Yes - 1 to 2 drinks per day or less | 5 Participants |
| Alcohol Use Yes - 3 drinks per day or more | 1 Participants |
| Anxiety/Depression Extreme | 0 Participants |
| Anxiety/Depression Missing | 1 Participants |
| Anxiety/Depression Moderate | 5 Participants |
| Anxiety/Depression None | 4 Participants |
| Current Tobacco Use No | 9 Participants |
| Current Tobacco Use Yes - Smoking | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height (cm) | 171.70 cm STANDARD_DEVIATION 5.921 |
| Mobility Confined | 1 Participants |
| Mobility Missing | 2 Participants |
| Mobility None | 0 Participants |
| Mobility Some | 7 Participants |
| Past Tobacco Use No | 0 Participants |
| Past Tobacco Use Yes - Smoking | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 8 Participants |
| Weight (kg) | 81.58 kg STANDARD_DEVIATION 11.052 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 10 |
| other Total, other adverse events | 10 / 10 |
| serious Total, serious adverse events | 7 / 10 |
Outcome results
Primary
Number of Participants Discontinued Due to AEs From the Injections of AMG0001
All summaries and analyses will be presented in tabular or graphical form. The study is not powered for the statistical inference and the test will be considered to be descriptive. Treatment-emergent adverse events (TEAEs) was evaluated, and a table showing the number and percentage of subjects with occurrences categorized by System Organ Class and Preferred Term was provided by whether the AE led to discontinuation.
Time frame: up to 18 Months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AMG0001 | Number of Participants Discontinued Due to AEs From the Injections of AMG0001 | Macular edema (likely unrelated) | 1 Participants |
| AMG0001 | Number of Participants Discontinued Due to AEs From the Injections of AMG0001 | Uterine leiomyosarcoma (possibly related) | 1 Participants |
Primary
Number of Participants With Adverse Events (AEs) Suspected to be Related to Injections of AMG0001
All summaries and analyses will be presented in tabular or graphical form. The study is not powered for the statistical inference and the test will be considered to be descriptive. Treatment-emergent adverse events (TEAEs) was evaluated, and a table showing the number and percentage of subjects with occurrences categorized by System Organ Class and Preferred Term was provided by causality (relationship to study drug).
Time frame: 18 months
Population: Not every subject analyzed may experience an adverse event likely related or possibly related to injections of AMG0001; therefore, the subject counts in the categories do not always add up to the total number analyzed
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AMG0001 | Number of Participants With Adverse Events (AEs) Suspected to be Related to Injections of AMG0001 | Infections and infestations (Mild) | 1 Participants |
| AMG0001 | Number of Participants With Adverse Events (AEs) Suspected to be Related to Injections of AMG0001 | Investigations (Moderate) | 1 Participants |
| AMG0001 | Number of Participants With Adverse Events (AEs) Suspected to be Related to Injections of AMG0001 | Eye disorders (Moderate) | 1 Participants |
| AMG0001 | Number of Participants With Adverse Events (AEs) Suspected to be Related to Injections of AMG0001 | General disorders & admin site conditions (Mild) | 1 Participants |
| AMG0001 | Number of Participants With Adverse Events (AEs) Suspected to be Related to Injections of AMG0001 | Vascular disorders (Severe) | 1 Participants |
| AMG0001 | Number of Participants With Adverse Events (AEs) Suspected to be Related to Injections of AMG0001 | Neoplasms benign, malignant, unspecified (Severe) | 1 Participants |
Secondary
Change From Baseline of VascuQol Score for the Index Limb by Visit
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.
Time frame: 18 months
Population: At each visit, only subjects who had a non-missing value at both baseline and the specific visit was summarized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AMG0001 | Change From Baseline of VascuQol Score for the Index Limb by Visit | Activity (LOCF) | 0.54 score on a scale | Standard Deviation 1.562 |
| AMG0001 | Change From Baseline of VascuQol Score for the Index Limb by Visit | Emotional (LOCF) | 0.52 score on a scale | Standard Deviation 0.935 |
| AMG0001 | Change From Baseline of VascuQol Score for the Index Limb by Visit | Overall (LOCF) | 0.58 score on a scale | Standard Deviation 1.567 |
| AMG0001 | Change From Baseline of VascuQol Score for the Index Limb by Visit | Pain (LOCF) | 0.71 score on a scale | Standard Deviation 2.61 |
| AMG0001 | Change From Baseline of VascuQol Score for the Index Limb by Visit | Social (LOCF) | 0.75 score on a scale | Standard Deviation 1.488 |
| AMG0001 | Change From Baseline of VascuQol Score for the Index Limb by Visit | Symptom (LOCF) | 0.58 score on a scale | Standard Deviation 2.055 |
Comparison: Overall (LOCF)p-value: 0.331t-test, 2 sided
Comparison: Activity (LOCF)p-value: 0.362t-test, 2 sided
Comparison: Emotional (LOCF)p-value: 0.159t-test, 2 sided
Comparison: Pain (LOCF)p-value: 0.468t-test, 2 sided
Comparison: Social (LOCF)p-value: 0.197t-test, 2 sided
Comparison: Symptom (LOCF)p-value: 0.448t-test, 2 sided
Secondary
Change in Hemodynamic Measurement of Baseline Calculated ABI of the Index Leg by Visit
Summary statistics was provided for baseline and change from baseline for ankle brachial index (ABI) by visit. At each visit, only subjects who have a non-missing value at both baseline and the specific visit was summarized. Two-sided one-sample t-test was performed for each visit and last observation carried forward (LOCF). ABI was calculated by dividing the ankle systolic blood pressure by the brachial systolic blood pressure. ABI was calculated at baseline and at each visit. The change in ABI at each visit compared to the baseline value was recorded.
Time frame: 18 months
Population: At each visit, only subjects who have non-missing values both at baseline and the specific visit was summarized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AMG0001 | Change in Hemodynamic Measurement of Baseline Calculated ABI of the Index Leg by Visit | Change from Baseline at Month 3 | 0.286 ratio | Standard Deviation 0.4711 |
| AMG0001 | Change in Hemodynamic Measurement of Baseline Calculated ABI of the Index Leg by Visit | Change from Baseline at Month 6 | 0.115 ratio | Standard Deviation 0.3642 |
| AMG0001 | Change in Hemodynamic Measurement of Baseline Calculated ABI of the Index Leg by Visit | Change from Baseline at Month 9 | 0.102 ratio | Standard Deviation 0.2395 |
| AMG0001 | Change in Hemodynamic Measurement of Baseline Calculated ABI of the Index Leg by Visit | Change from Baseline at Month 12 | 0.254 ratio | Standard Deviation 0.3909 |
| AMG0001 | Change in Hemodynamic Measurement of Baseline Calculated ABI of the Index Leg by Visit | Change from Baseline at Month 15 | -0.097 ratio | Standard Deviation 0.1815 |
| AMG0001 | Change in Hemodynamic Measurement of Baseline Calculated ABI of the Index Leg by Visit | Change from Baseline at Month 18 | 0.210 ratio | Standard Deviation 0.1709 |
| AMG0001 | Change in Hemodynamic Measurement of Baseline Calculated ABI of the Index Leg by Visit | Change from Baseline at LOCF | 0.431 ratio | Standard Deviation 0.3365 |
Comparison: Change from Baseline at Month 3p-value: 0.246t-test, 2 sided
Comparison: Change from Baseline at Month 6p-value: 0.474t-test, 2 sided
Comparison: Change from Baseline at Month 9p-value: 0.395t-test, 2 sided
Comparison: Change from Baseline at Month 12p-value: 0.22t-test, 2 sided
Comparison: Change from Baseline at Month 15p-value: 0.454t-test, 2 sided
Comparison: Change from Baseline at Month 18p-value: 0.167t-test, 2 sided
Comparison: Change from Baseline at LOCFp-value: 0.015t-test, 2 sided
Secondary
Change in Hemodynamic Measurement of Baseline Calculated Toe Brachial Index (TBI) of the Index Leg by Visit
Summary statistics was provided for baseline and change from baseline for toe brachial index (TBI) by visit. At each visit, only subjects who have a non-missing value at both baseline and the specific visit was summarized. Two-sided one-sample t-test was performed for each visit and last observation carried forward (LOCF). TBI was calculated by dividing the toe systolic blood pressure by the brachial systolic blood pressure. TBI was calculated at baseline and at each visit. The change in TBI at each visit compared to the baseline value was recorded.
Time frame: 18 months
Population: At each visit, only subjects who have non-missing values both at baseline and the specific visit was summarized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AMG0001 | Change in Hemodynamic Measurement of Baseline Calculated Toe Brachial Index (TBI) of the Index Leg by Visit | Change from Baseline at Month 12 | 0.044 ratio | Standard Deviation 0.0619 |
| AMG0001 | Change in Hemodynamic Measurement of Baseline Calculated Toe Brachial Index (TBI) of the Index Leg by Visit | Change from Baseline at Month 3 | 0.0180 ratio | Standard Deviation 0.0709 |
| AMG0001 | Change in Hemodynamic Measurement of Baseline Calculated Toe Brachial Index (TBI) of the Index Leg by Visit | Change from Baseline at Month 6 | 0.040 ratio | Standard Deviation 0.071 |
| AMG0001 | Change in Hemodynamic Measurement of Baseline Calculated Toe Brachial Index (TBI) of the Index Leg by Visit | Change from Baseline at Month 9 | 0.040 ratio | Standard Deviation 0.0779 |
| AMG0001 | Change in Hemodynamic Measurement of Baseline Calculated Toe Brachial Index (TBI) of the Index Leg by Visit | Change from Baseline at Month 15 | 0.060 ratio | Standard Deviation 0.0557 |
| AMG0001 | Change in Hemodynamic Measurement of Baseline Calculated Toe Brachial Index (TBI) of the Index Leg by Visit | Change from Baseline at Month 18 | 0.123 ratio | Standard Deviation 0.0907 |
| AMG0001 | Change in Hemodynamic Measurement of Baseline Calculated Toe Brachial Index (TBI) of the Index Leg by Visit | Change from Baseline at LOCF | 0.095 ratio | Standard Deviation 0.0831 |
Comparison: Change from Baseline at Month 3p-value: 0.655t-test, 2 sided
Comparison: Change from Baseline at Month 6p-value: 0.226t-test, 2 sided
Comparison: Change from Baseline at Month 9p-value: 0.38t-test, 2 sided
Comparison: Change from Baseline at Month 12p-value: 0.187t-test, 2 sided
Comparison: Change from Baseline at Month 15p-value: 0.203t-test, 2 sided
Comparison: Change from Baseline at Month 18p-value: 0.074t-test, 2 sided
Comparison: Change from Baseline at LOCFp-value: 0.038t-test, 2 sided
Secondary
Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit
Summary statistics was provided for baseline and change from baseline for ankle systolic pressure by visit. At each visit, only subjects who have a non-missing value at both baseline and the specific visit was summarized. Two-sided one-sample t-test was performed for each visit and last observation carried forward (LOCF).
Time frame: 18 months
Population: At each visit, only subjects who have non-missing values both at baseline and the specific visit was summarized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit | Change from Baseline at Month 9 (Dorsalis pedis) | 27.6 mmHg | Standard Deviation 58.12 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit | Change from Baseline at Month 12 (Dorsalis pedis) | 11.5 mmHg | Standard Deviation 30.16 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit | Change from Baseline at LOCF (Dorsalis pedis) | 55.0 mmHg | Standard Deviation 39.07 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit | Change from Baseline at Month 3 (Posterior tibial) | 10.5 mmHg | Standard Deviation 52.45 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit | Change from Baseline at Month 6 (Posterior tibial) | -4.8 mmHg | Standard Deviation 18.41 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit | Change from Baseline at Month 3 (Dorsalis pedis) | 10.8 mmHg | Standard Deviation 43.5 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit | Change from Baseline at Month 6 (Dorsalis pedis) | 40.7 mmHg | Standard Deviation 88.18 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit | Change from Baseline at Month 15 (Dorsalis pedis) | -13.3 mmHg | Standard Deviation 31.13 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit | Change from Baseline at Month 18 (Dorsalis pedis) | 31.3 mmHg | Standard Deviation 22.81 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit | Change from Baseline at Month 9 (Posterior tibial) | -8.0 mmHg | Standard Deviation 25.02 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit | Change from Baseline at Month 12 (Posterior tibial | 2.8 mmHg | Standard Deviation 20.76 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit | Change from Baseline at Month 15 (Posterior tibial | -14.3 mmHg | Standard Deviation 23.18 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit | Change from Baseline at Month 18 (Posterior tibial | 36.7 mmHg | Standard Deviation 29.28 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Ankle Systolic Pressure (mmHg) of the Index Leg by Visit | Change from Baseline at LOCF (Posterior tibial) | 19.8 mmHg | Standard Deviation 33.66 |
Comparison: Change from Baseline at Month 3 (Dorsalis pedis)p-value: 0.655t-test, 2 sided
Comparison: Change from Baseline at Month 6 (Dorsalis pedis)p-value: 0.31t-test, 2 sided
Comparison: Change from Baseline at Month 9 (Dorsalis pedis)p-value: 0.348t-test, 2 sided
Comparison: Change from Baseline at Month 12 (Dorsalis pedis)p-value: 0.501t-test, 2 sided
Comparison: Change from Baseline at Month 15 (Dorsalis pedis)p-value: 0.536t-test, 2 sided
Comparison: Change from Baseline at Month 18 (Dorsalis pedis)p-value: 0.14t-test, 2 sided
Comparison: Change from Baseline at LOCF (Dorsalis pedis)p-value: 0.018t-test, 2 sided
Comparison: Change from baseline at Month 3 (Posterior tibial)p-value: 0.716t-test, 2 sided
Comparison: Change from baseline at Month 6 (Posterior tibial)p-value: 0.641t-test, 2 sided
Comparison: Change from baseline at Month 9 (Posterior tibial)p-value: 0.514t-test, 2 sided
Comparison: Change from baseline at Month 12 (Posterior tibial)p-value: 0.808t-test, 2 sided
Comparison: Change from baseline at Month 15 (Posterior tibial)p-value: 0.396t-test, 2 sided
Comparison: Change from baseline at Month 18 (Posterior tibial)p-value: 0.162t-test, 2 sided
Comparison: Change from baseline at LOCF (Posterior tibial)p-value: 0.259t-test, 2 sided
Secondary
Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg)
Summary statistics was provided for baseline and change from baseline for right/left brachial systolic pressure by visit. At each visit, only subjects who have a non-missing value at both baseline and the specific visit was summarized. Two-sided one-sample t-test was performed for each visit and last observation carried forward (LOCF).
Time frame: 18 months
Population: At each visit, only subjects who have non-missing values both at baseline and the specific visit was summarized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg) | Change from Baseline at Month 6 (Right) | -1.1 mmHg | Standard Deviation 30.8 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg) | Change from Baseline at Month 9 (Right) | -4.2 mmHg | Standard Deviation 13.12 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg) | Change from Baseline at Month 12 (Right) | -9.6 mmHg | Standard Deviation 18.12 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg) | Change from Baseline at Month 15 (Right) | -4.3 mmHg | Standard Deviation 8.14 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg) | Change from Baseline at Month 3 (Left) | -10.9 mmHg | Standard Deviation 18.67 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg) | Change from Baseline at Month 6 (Left) | -7.8 mmHg | Standard Deviation 20.52 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg) | Change from Baseline at Month 9 (Left) | -0.6 mmHg | Standard Deviation 13.9 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg) | Change from Baseline at Month 3 (Right) | -4.5 mmHg | Standard Deviation 24.42 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg) | Change from Baseline at Month 18 (Right) | 5.8 mmHg | Standard Deviation 15.22 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg) | Change from Baseline at LOCF (Right) | 12.5 mmHg | Standard Deviation 20.91 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg) | Change from Baseline at Month 12 (Left) | -6.6 mmHg | Standard Deviation 16.79 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg) | Change from Baseline at Month 15 (Left) | 1.0 mmHg | Standard Deviation 15.77 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg) | Change from Baseline at Month 18 (Left) | 8.3 mmHg | Standard Deviation 13.2 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Brachial Systolic Pressure (mmHg) | Change from Baseline at LOCF (Left) | 6.6 mmHg | Standard Deviation 13.7 |
Comparison: Change from Baseline at Month 3p-value: 0.671t-test, 2 sided
Comparison: Change from Baseline at Month 6p-value: 0.925t-test, 2 sided
Comparison: Change from Baseline at Month 9p-value: 0.514t-test, 2 sided
Comparison: Change from Baseline at Month 12p-value: 0.302t-test, 2 sided
Comparison: Change from Baseline at Month 15p-value: 0.373t-test, 2 sided
Comparison: Change from Baseline at Month 18p-value: 0.505t-test, 2 sided
Comparison: Change from Baseline at LOCFp-value: 0.135t-test, 2 sided
Comparison: Change from baseline at month 3 (Left)p-value: 0.175t-test, 2 sided
Comparison: Change from baseline at month 6 (Left)p-value: 0.393t-test, 2 sided
Comparison: Change from baseline at month 9 (Left)p-value: 0.928t-test, 2 sided
Comparison: Change from baseline at month 12 (Left)p-value: 0.429t-test, 2 sided
Comparison: Change from baseline at month 15 (Left)p-value: 0.907t-test, 2 sided
Comparison: Change from baseline at month 18 (Left)p-value: 0.3t-test, 2 sided
Comparison: Change from baseline at LOCF (Left)p-value: 0.214t-test, 2 sided
Secondary
Change in Hemodynamic Measurements of Change From Baseline Value of Toe Systolic Pressure (mmHg)
Summary statistics was provided for baseline and change from baseline for toe systolic pressure by visit. At each visit, only subjects who have a non-missing value at both baseline and the specific visit was summarized. Two-sided one-sample t-test was performed for each visit and last observation carried forward (LOCF).
Time frame: 18 months
Population: At each visit, only subjects who have non-missing values both at baseline and the specific visit was summarized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Toe Systolic Pressure (mmHg) | Change from Baseline at Month 3 | 0.5 mmHg | Standard Deviation 11.96 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Toe Systolic Pressure (mmHg) | Change from Baseline at Month 6 | 3.7 mmHg | Standard Deviation 12.6 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Toe Systolic Pressure (mmHg) | Change from Baseline at Month 9 | 5.5 mmHg | Standard Deviation 13.48 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Toe Systolic Pressure (mmHg) | Change from Baseline at Month 12 | 4.2 mmHg | Standard Deviation 9.12 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Toe Systolic Pressure (mmHg) | Change from Baseline at Month 15 | 6.7 mmHg | Standard Deviation 7.37 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Toe Systolic Pressure (mmHg) | Change from Baseline at Month 18 | 19.8 mmHg | Standard Deviation 13.33 |
| AMG0001 | Change in Hemodynamic Measurements of Change From Baseline Value of Toe Systolic Pressure (mmHg) | Change from Baseline at LOCF | 16.0 mmHg | Standard Deviation 12.05 |
Comparison: Change from Baseline at Month 3p-value: 0.939t-test, 2 sided
Comparison: Change from Baseline at Month 6p-value: 0.508t-test, 2 sided
Comparison: Change from Baseline at Month 9p-value: 0.474t-test, 2 sided
Comparison: Change from Baseline at Month 12p-value: 0.361t-test, 2 sided
Comparison: Change from Baseline at Month 15p-value: 0.258t-test, 2 sided
Comparison: Change from baseline at Month 18p-value: 0.059t-test, 2 sided
Comparison: Change from Baseline at LOCFp-value: 0.023t-test, 2 sided
Secondary
Number of Participants in Whom Rest Pain (Based on 10 cm VAS Scale) Reduces by 20 mm (2 cm) or More or Was Completely Relieved.
All summaries and analyses will be presented in tabular or graphical form. The study is not powered for the statistical inference and the test will be considered to be descriptive. 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).
Time frame: 18 months
Population: 8 subjects had available data through Month 6; 6 subjects through Month 12; 4 subjects through Month 18
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AMG0001 | Number of Participants in Whom Rest Pain (Based on 10 cm VAS Scale) Reduces by 20 mm (2 cm) or More or Was Completely Relieved. | Day 0 to Month 6 | 1 Participants |
| AMG0001 | Number of Participants in Whom Rest Pain (Based on 10 cm VAS Scale) Reduces by 20 mm (2 cm) or More or Was Completely Relieved. | Month 6 to Month 12 | 2 Participants |
| AMG0001 | Number of Participants in Whom Rest Pain (Based on 10 cm VAS Scale) Reduces by 20 mm (2 cm) or More or Was Completely Relieved. | Month 12 to Month 18 | 2 Participants |
Secondary
Number of Participants in Whom the Largest Ulcer Healed Completely or Gets Smaller (Photo Confirmation)
All summaries and analyses will be presented in tabular or graphical form. The study is not powered for the statistical inference and the test will be considered to be descriptive. A table showing the number of subjects completely healed in the target ulcer was provided at up to 6 months, \> 6 months to 12 months, from \>12 months to 18 months.
Time frame: 18 Months
Population: 4 subjects classified as Rutherford Class 5 at Baseline had available data through Month 6; 1 subject through Month 12; 0 subject through Month 18
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AMG0001 | Number of Participants in Whom the Largest Ulcer Healed Completely or Gets Smaller (Photo Confirmation) | Month 12 to Month 18 | 0 Participants |
| AMG0001 | Number of Participants in Whom the Largest Ulcer Healed Completely or Gets Smaller (Photo Confirmation) | Day 0 to Month 6 | 0 Participants |
| AMG0001 | Number of Participants in Whom the Largest Ulcer Healed Completely or Gets Smaller (Photo Confirmation) | Month 6 to Month 12 | 0 Participants |
Secondary
Number of Participants With Shift From Baseline in Rutherford Classification
Shift from baseline in Rutherford classification was summarized by study visit. Patients enrolled in the study were classified as either Rutherford 4 or Rutherford 5 at baseline. Rutherford category (clinical description) 0 (Asymptomatic - no hemodynamically significant occlusive disease) 1. (Mild claudication) 2. (Moderate claudication) 3. (Severe claudication) 4. (Ischemic rest pain) 5. (Minor tissue loss - nonhealing ulcer, focal gangrene with diffuse pedal ischemia) 6. (Major tissue loss - extending above TM level, functional foot no longer salvageable)
Time frame: 18 months
Population: Number analyzed in one or more rows differs from overall number analyzed due to subject study discontinuation.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Up to Month 3 (Baseline R4) | Shift to R6 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 15 to 18 (Baseline R5) | Shift to R2 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 15 to 18 (Baseline R5) | Shift to R5 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Up to Month 3 (Baseline R4) | Shift to R1 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Up to Month 3 (Baseline R4) | Shift to R2 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Up to Month 3 (Baseline R4) | Shift to R3 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Up to Month 3 (Baseline R4) | Shift to R4 | 4 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Up to Month 3 (Baseline R4) | Shift to R5 | 1 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Up to Month 3 (Baseline R4) | Discontinuation due to Death, AE or CLI Event | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 3 to 6 (Baseline R4) | Shift to R1 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 3 to 6 (Baseline R4) | Shift to R2 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 3 to 6 (Baseline R4) | Shift to R3 | 1 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 3 to 6 (Baseline R4) | Shift to R4 | 2 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 3 to 6 (Baseline R4) | Shift to R5 | 1 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 3 to 6 (Baseline R4) | Shift to R6 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 3 to 6 (Baseline R4) | Discontinuation due to Death, AE or CLI Event | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 6 to 9 (Baseline R4) | Shift to R1 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 6 to 9 (Baseline R4) | Shift to R2 | 1 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 6 to 9 (Baseline R4) | Shift to R3 | 1 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 6 to 9 (Baseline R4) | Shift to R4 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 6 to 9 (Baseline R4) | Shift to R5 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 6 to 9 (Baseline R4) | Shift to R6 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 6 to 9 (Baseline R4) | Discontinuation due to Death, AE or CLI Event | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 9 to 12 (Baseline R4) | Shift to R1 | 1 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 9 to 12 (Baseline R4) | Shift to R2 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 9 to 12 (Baseline R4) | Shift to R3 | 1 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 9 to 12 (Baseline R4) | Shift to R4 | 1 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 9 to 12 (Baseline R4) | Shift to R5 | 1 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 9 to 12 (Baseline R4) | Shift to R6 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 9 to 12 (Baseline R4) | Discontinuation due to Death, AE or CLI Event | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 12 to 15 (Baseline R4) | Shift to R1 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 12 to 15 (Baseline R4) | Shift to R2 | 1 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 12 to 15 (Baseline R4) | Shift to R3 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 12 to 15 (Baseline R4) | Shift to R4 | 1 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 12 to 15 (Baseline R4) | Shift to R5 | 1 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 12 to 15 (Baseline R4) | Shift to R6 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 12 to 15 (Baseline R4) | Discontinuation due to Death, AE or CLI Event | 1 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 15 to 18 (Baseline R4) | Shift to R1 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 15 to 18 (Baseline R4) | Shift to R2 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 15 to 18 (Baseline R4) | Shift to R3 | 2 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 15 to 18 (Baseline R4) | Shift to R4 | 1 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 15 to 18 (Baseline R4) | Shift to R5 | 1 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 15 to 18 (Baseline R4) | Shift to R6 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 15 to 18 (Baseline R4) | Discontinuation due to Death, AE or CLI Event | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Up to Month 3 (Baseline R5) | Shift to R1 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Up to Month 3 (Baseline R5) | Shift to R2 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Up to Month 3 (Baseline R5) | Shift to R3 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Up to Month 3 (Baseline R5) | Shift to R4 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Up to Month 3 (Baseline R5) | Shift to R5 | 3 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Up to Month 3 (Baseline R5) | Shift to R6 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Up to Month 3 (Baseline R5) | Discontinuation due to Death, AE or CLI Event | 1 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 3 to 6 (Baseline R5) | Shift to R1 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 3 to 6 (Baseline R5) | Shift to R2 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 3 to 6 (Baseline R5) | Shift to R3 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 3 to 6 (Baseline R5) | Shift to R4 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 3 to 6 (Baseline R5) | Shift to R5 | 2 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 3 to 6 (Baseline R5) | Shift to R6 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 3 to 6 (Baseline R5) | Discontinuation due to Death, AE or CLI Event | 1 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 6 to 9 (Baseline R5) | Shift to R1 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 6 to 9 (Baseline R5) | Shift to R2 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 6 to 9 (Baseline R5) | Shift to R3 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 6 to 9 (Baseline R5) | Shift to R4 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 6 to 9 (Baseline R5) | Shift to R5 | 2 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 6 to 9 (Baseline R5) | Shift to R6 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 6 to 9 (Baseline R5) | Discontinuation due to Death, AE or CLI Event | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 9 to 12 (Baseline R5) | Shift to R1 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 9 to 12 (Baseline R5) | Shift to R2 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 9 to 12 (Baseline R5) | Shift to R3 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 9 to 12 (Baseline R5) | Shift to R4 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 9 to 12 (Baseline R5) | Shift to R5 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 9 to 12 (Baseline R5) | Shift to R6 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 9 to 12 (Baseline R5) | Discontinuation due to Death, AE or CLI Event | 2 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 12 to 15 (Baseline R5) | Shift to R1 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 12 to 15 (Baseline R5) | Shift to R2 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 12 to 15 (Baseline R5) | Shift to R3 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 12 to 15 (Baseline R5) | Shift to R4 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 12 to 15 (Baseline R5) | Shift to R5 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 12 to 15 (Baseline R5) | Shift to R6 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 12 to 15 (Baseline R5) | Discontinuation due to Death, AE or CLI Event | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 15 to 18 (Baseline R5) | Shift to R1 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 15 to 18 (Baseline R5) | Shift to R3 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 15 to 18 (Baseline R5) | Shift to R4 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 15 to 18 (Baseline R5) | Shift to R6 | 0 Participants |
| AMG0001 | Number of Participants With Shift From Baseline in Rutherford Classification | Month 15 to 18 (Baseline R5) | Discontinuation due to Death, AE or CLI Event | 0 Participants |
Secondary
Number of Participants With Worsening CLI Event of Index Leg
A summary table and listing of worsening CLI-related events of the index leg including any new or worsening events, worsening rest pain, new ulcer or worsening ulcer, new or worsening wound infection, peripheral vascular intervention, complication of a peripheral vascular intervention, cellulitis, and amputation due to worsening CLI was provided.
Time frame: 18 months
Population: Number analyzed in one or more rows differs from overall number analyzed due to subject study discontinuation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Up to 3M : Wound infection (new or worsening) | 1 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Up to 3M : Amputation due to Worsening CLI | 1 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Up to 3M : Peripheral vascular intervention | 1 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 9M to 12M : Wound infection (new or worsening) | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Month 9 up to 12 : Amputation due to Worsening CLI | 1 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Month 15 up to 18 : Worsening of ulcer | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Up to 3M : Any CLI-related events | 3 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Up to 3M : Worsening rest pain | 3 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Up to 3M : New ulcer | 2 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Up to 3M : Complication vascular intervention | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Up to 3M : Cellulitis | 1 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Up to 3M : Worsening of ulcer | 1 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 3M to 6M : Any CLI-related events | 2 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 3M to 6M : Worsening rest pain | 2 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 3M to 6M : New ulcer | 2 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 3M to 6M : Wound infection (new or worsening) | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 3M to 6M : Amputation due to Worsening CLI | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 3M to 6M : Peripheral vascular intervention | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 3M to 6M : Complication of vascular intervention | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 3M to 6M : Cellulitis | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 3M to 6M : Worsening of ulcer | 1 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 6M to 9M : Any CLI-related events | 2 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 6M to 9M : Worsening rest pain | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 6M to 9M : New ulcer | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 6M to 9M : Wound infection (new or worsening) | 1 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Month 6 up to 9 : Amputation due to Worsening CLI | 2 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Month 6 up to 9 : Peripheral vascular intervention | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 6M to 9M : Complication of vascular intervention | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Month 6 up to 9 : Cellulitis | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Month 6 up to 9 : Worsening of ulcer | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 9M to 12M : Any CLI-related events | 1 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Month 9 up to 12 : Worsening rest pain | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Month 9 up to 12 : New ulcer | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 9M to 12M : Peripheral vascular intervention | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 9M to 12M : Complication of vascular intervention | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Month 9 up to 12 : Cellulitis | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Month 9 up to 12 : Worsening of ulcer | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 12M to 15M : Any CLI-related events | 2 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Month 12 up to 15 : Worsening rest pain | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Month 12 up to 15 : New ulcer | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 12M to 15M : Wound infection (new or worsening) | 1 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 12M to 15M : Amputation due to Worsening CLI | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 12M to 15M : Peripheral vascular intervention | 1 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 12M to 15M : Complication of vascular intervention | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Month 12 up to 15 : Cellulitis | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Month 12 up to 15 : Worsening of ulcer | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 15M to 18M : Any CLI-related events | 2 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Month 15 up to 18 : Worsening rest pain | 1 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Month 15 up to 18 : New ulcer | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 15M to 18M : Wound infection (new or worsening) | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 15M to 18M : Amputation due to Worsening CLI | 1 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 15M to 18M : Peripheral vascular intervention | 1 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | 15M to 18M : Complication of vascular intervention | 0 Participants |
| AMG0001 | Number of Participants With Worsening CLI Event of Index Leg | Month 15 up to 18 : Cellulitis | 0 Participants |
Secondary
Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death
A summary table including counts and percentages was provided for subjects who had MI, stroke, major amputation, revascularization, or all-cause death for the time periods: 0 to Month 6, 0 to Month 12, 0 to Month 18.
Time frame: 18 months
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| AMG0001 | Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death | Month 0 to 6 | Myocardial infarction | 0 Participants |
| AMG0001 | Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death | Month 0 to 6 | Stroke | 0 Participants |
| AMG0001 | Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death | Month 0 to 6 | Major amputation of the index leg | 1 Participants |
| AMG0001 | Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death | Month 0 to 6 | Revascularization of the index leg | 1 Participants |
| AMG0001 | Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death | Month 0 to 6 | All-cause death | 1 Participants |
| AMG0001 | Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death | Month 0 to 6 | No events recorded | 7 Participants |
| AMG0001 | Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death | Month 0 to 12 | Myocardial infarction | 0 Participants |
| AMG0001 | Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death | Month 0 to 12 | Stroke | 0 Participants |
| AMG0001 | Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death | Month 0 to 12 | Major amputation of the index leg | 2 Participants |
| AMG0001 | Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death | Month 0 to 12 | Revascularization of the index leg | 1 Participants |
| AMG0001 | Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death | Month 0 to 12 | All-cause death | 2 Participants |
| AMG0001 | Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death | Month 0 to 12 | No events recorded | 5 Participants |
| AMG0001 | Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death | Month 0 to 18 | Myocardial infarction | 0 Participants |
| AMG0001 | Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death | Month 0 to 18 | Stroke | 0 Participants |
| AMG0001 | Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death | Month 0 to 18 | Major amputation of the index leg | 2 Participants |
| AMG0001 | Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death | Month 0 to 18 | Revascularization of the index leg | 3 Participants |
| AMG0001 | Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death | Month 0 to 18 | All-cause death | 3 Participants |
| AMG0001 | Subjects Who Had Myocardial Infarction (MI), Stroke, Major Amputation, Revascularization (by Surgical Bypass, Endovascular Intervention, Hybrid Procedure), or All-cause Death | Month 0 to 18 | No events recorded | 2 Participants |