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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)
The primary objectives of the study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG0001 | Experimental | Hepatocyte Growth Factor (HGF) Plasmid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HGF Plasmid | Biological | Intramuscular injection in the affected limb. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 18 months |
| 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. | up to 18 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Powell, MD | Dartmouth-Hitchcock Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
Not provided
10 subjects were enrolled at a single clinical site.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AMG0001 | Hepatocyte Growth Factor (HGF) Plasmid HGF Plasmid: Intramuscular injection in the affected limb. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AMG0001 | Hepatocyte Growth Factor (HGF) Plasmid HGF Plasmid: Intramuscular injection in the affected limb. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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 | Posted | Count of Participants | Participants | 18 months |
|
Adverse events were documented and followed from the start of the first dose of study product (Day 0), until the final outcome is known or until the end of the study safety follow-up period (Month 36).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AMG0001 | Hepatocyte Growth Factor (HGF) Plasmid HGF Plasmid: Intramuscular injection in the affected limb. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Administration site reaction | General disorders | MedDRA (16.1) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Susan Pitman Lowenthal | AnGes USA, Inc. | 240-780-9025 | spitmanlowenthal@anges-usa.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 3, 2016 | Oct 11, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 20, 2018 | Oct 11, 2019 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| D014652 | Vascular Diseases |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
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| 18 Months |
| 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."
| 18 months |
| 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. | 18 months |
| 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). | 18 months |
| 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). | 18 months |
| 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). | 18 months |
| 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. | 18 months |
| 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. | 18 months |
| 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. | 18 months |
| 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. | 18 months |
| 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)
| 18 months |
| Death |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight (kg) | Mean | Standard Deviation | kg |
|
| Height (cm) | Mean | Standard Deviation | cm |
|
| Past Tobacco Use | Count of Participants | Participants |
|
| Current Tobacco Use | Count of Participants | Participants |
|
| Alcohol Use | Count of Participants | Participants |
|
| Mobility | Count of Participants | Participants |
|
| Ability to Self-care | Count of Participants | Participants |
|
| Anxiety/Depression | Count of Participants | Participants |
|
|
|
| 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. | Posted | Count of Participants | Participants | up to 18 Months |
|
|
|
| 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. | 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 | Posted | Count of Participants | Participants | 18 Months |
|
|
|
| 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."
| 8 subjects had available data through Month 6; 6 subjects through Month 12; 4 subjects through Month 18 | Posted | Count of Participants | Participants | 18 months |
|
|
|
| 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. | At each visit, only subjects who had a non-missing value at both baseline and the specific visit was summarized. | Posted | Mean | Standard Deviation | score on a scale | 18 months |
|
|
|
|
| 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). | At each visit, only subjects who have non-missing values both at baseline and the specific visit was summarized. | Posted | Mean | Standard Deviation | mmHg | 18 months |
|
|
|
|
| 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). | At each visit, only subjects who have non-missing values both at baseline and the specific visit was summarized. | Posted | Mean | Standard Deviation | mmHg | 18 months |
|
|
|
|
| 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). | At each visit, only subjects who have non-missing values both at baseline and the specific visit was summarized. | Posted | Mean | Standard Deviation | mmHg | 18 months |
|
|
|
|
| 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. | At each visit, only subjects who have non-missing values both at baseline and the specific visit was summarized. | Posted | Mean | Standard Deviation | ratio | 18 months |
|
|
|
|
| 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. | At each visit, only subjects who have non-missing values both at baseline and the specific visit was summarized. | Posted | Mean | Standard Deviation | ratio | 18 months |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | 18 months |
|
|
|
| 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. | Number analyzed in one or more rows differs from overall number analyzed due to subject study discontinuation. | Posted | Count of Participants | Participants | 18 months |
|
|
|
| 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)
| Number analyzed in one or more rows differs from overall number analyzed due to subject study discontinuation. | Posted | Count of Participants | Participants | 18 months |
|
|
|
| 3 |
| 10 |
| 7 |
| 10 |
| 10 |
| 10 |
| Cardiac failure | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Gastrointestinal hemorrhage | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Intestinal ischemia | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
|
| Post procedural hematoma | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
|
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
|
| Carotid artery stenosis | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Diabetic neuropathy | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Leg amputation | Surgical and medical procedures | MedDRA (16.1) | Non-systematic Assessment |
|
| Toe amputation | Surgical and medical procedures | MedDRA (16.1) | Non-systematic Assessment |
|
| Ischemic limb pain | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Peripheral ischemia | Vascular disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Muscle atrophy | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Uterine Leiomyosarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.1) | Non-systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Injection site discharge | General disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Oversensing | General disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
|
| Laceration | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
|
| Abdominal wound dehiscence | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
|
| Anemia postoperative | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
|
| Skin wound | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA (16.1) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
|
| Pseudomonas infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
|
| Wound infection | Infections and infestations | MedDRA (16.1) | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Atrial flutter | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Cardiac failure acute | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Duodenal ulcer | Gastrointestinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Blood blister | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA (16.1) | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Myoclonus | Nervous system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| anaemia | Blood and lymphatic system disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Diabetic retinopathy | Eye disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Macular oedema | Eye disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Vitreous adhesions | Eye disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Renal failure chronic | Renal and urinary disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (16.1) | Non-systematic Assessment |
|
Not provided
Not provided
| D016491 |
| Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
|
| Month 12 to Month 18 |
|
|
|
| Month 12 to Month 18 |
|
|
| Title | Measurements |
|---|---|
|
| Pain (LOCF) |
|
| Social (LOCF) |
|
| Symptom (LOCF) |
|
| Superiority |
| Emotional (LOCF) | t-test, 2 sided | 0.159 | Superiority |
| Pain (LOCF) | t-test, 2 sided | 0.468 | Superiority |
| Social (LOCF) | t-test, 2 sided | 0.197 | Superiority |
| Symptom (LOCF) | t-test, 2 sided | 0.448 | Superiority |
|
| Change from Baseline at Month 9 |
|
|
| Change from Baseline at Month 12 |
|
|
| Change from Baseline at Month 15 |
|
|
| Change from Baseline at Month 18 |
|
|
| Change from Baseline at LOCF |
|
|
| 0.508 |
| Superiority |
| Change from Baseline at Month 9 | t-test, 2 sided | 0.474 | Superiority |
| Change from Baseline at Month 12 | t-test, 2 sided | 0.361 | Superiority |
| Change from Baseline at Month 15 | t-test, 2 sided | 0.258 | Superiority |
| Change from baseline at Month 18 | t-test, 2 sided | 0.059 | Superiority |
| Change from Baseline at LOCF | t-test, 2 sided | 0.023 | Superiority |
|
| Change from Baseline at Month 9 (Dorsalis pedis) |
|
|
| Change from Baseline at Month 12 (Dorsalis pedis) |
|
|
| Change from Baseline at Month 15 (Dorsalis pedis) |
|
|
| Change from Baseline at Month 18 (Dorsalis pedis) |
|
|
| Change from Baseline at LOCF (Dorsalis pedis) |
|
|
| Change from Baseline at Month 3 (Posterior tibial) |
|
|
| Change from Baseline at Month 6 (Posterior tibial) |
|
|
| Change from Baseline at Month 9 (Posterior tibial) |
|
|
| Change from Baseline at Month 12 (Posterior tibial |
|
|
| Change from Baseline at Month 15 (Posterior tibial |
|
|
| Change from Baseline at Month 18 (Posterior tibial |
|
|
| Change from Baseline at LOCF (Posterior tibial) |
|
|
| 0.310 |
| Superiority |
| Change from Baseline at Month 9 (Dorsalis pedis) | t-test, 2 sided | 0.348 | Superiority |
| Change from Baseline at Month 12 (Dorsalis pedis) | t-test, 2 sided | 0.501 | Superiority |
| Change from Baseline at Month 15 (Dorsalis pedis) | t-test, 2 sided | 0.536 | Superiority |
| Change from Baseline at Month 18 (Dorsalis pedis) | t-test, 2 sided | 0.140 | Superiority |
| Change from Baseline at LOCF (Dorsalis pedis) | t-test, 2 sided | 0.018 | Superiority |
| Change from baseline at Month 3 (Posterior tibial) | t-test, 2 sided | 0.716 | Superiority |
| Change from baseline at Month 6 (Posterior tibial) | t-test, 2 sided | 0.641 | Superiority |
| Change from baseline at Month 9 (Posterior tibial) | t-test, 2 sided | 0.514 | Superiority |
| Change from baseline at Month 12 (Posterior tibial) | t-test, 2 sided | 0.808 | Superiority |
| Change from baseline at Month 15 (Posterior tibial) | t-test, 2 sided | 0.396 | Superiority |
| Change from baseline at Month 18 (Posterior tibial) | t-test, 2 sided | 0.162 | Superiority |
| Change from baseline at LOCF (Posterior tibial) | t-test, 2 sided | 0.259 | Superiority |
|
| Change from Baseline at Month 9 (Right) |
|
|
| Change from Baseline at Month 12 (Right) |
|
|
| Change from Baseline at Month 15 (Right) |
|
|
| Change from Baseline at Month 18 (Right) |
|
|
| Change from Baseline at LOCF (Right) |
|
|
| Change from Baseline at Month 3 (Left) |
|
|
| Change from Baseline at Month 6 (Left) |
|
|
| Change from Baseline at Month 9 (Left) |
|
|
| Change from Baseline at Month 12 (Left) |
|
|
| Change from Baseline at Month 15 (Left) |
|
|
| Change from Baseline at Month 18 (Left) |
|
|
| Change from Baseline at LOCF (Left) |
|
|
| 0.925 |
| Superiority |
| Change from Baseline at Month 9 | t-test, 2 sided | 0.514 | Superiority |
| Change from Baseline at Month 12 | t-test, 2 sided | 0.302 | Superiority |
| Change from Baseline at Month 15 | t-test, 2 sided | 0.373 | Superiority |
| Change from Baseline at Month 18 | t-test, 2 sided | 0.505 | Superiority |
| Change from Baseline at LOCF | t-test, 2 sided | 0.135 | Superiority |
| Change from baseline at month 3 (Left) | t-test, 2 sided | 0.175 | Superiority |
| Change from baseline at month 6 (Left) | t-test, 2 sided | 0.393 | Superiority |
| Change from baseline at month 9 (Left) | t-test, 2 sided | 0.928 | Superiority |
| Change from baseline at month 12 (Left) | t-test, 2 sided | 0.429 | Superiority |
| Change from baseline at month 15 (Left) | t-test, 2 sided | 0.907 | Superiority |
| Change from baseline at month 18 (Left) | t-test, 2 sided | 0.300 | Superiority |
| Change from baseline at LOCF (Left) | t-test, 2 sided | 0.214 | Superiority |
|
| Change from Baseline at Month 9 |
|
|
| Change from Baseline at Month 12 |
|
|
| Change from Baseline at Month 15 |
|
|
| Change from Baseline at Month 18 |
|
|
| Change from Baseline at LOCF |
|
|
| 0.226 |
| Superiority |
| Change from Baseline at Month 9 | t-test, 2 sided | 0.380 | Superiority |
| Change from Baseline at Month 12 | t-test, 2 sided | 0.187 | Superiority |
| Change from Baseline at Month 15 | t-test, 2 sided | 0.203 | Superiority |
| Change from Baseline at Month 18 | t-test, 2 sided | 0.074 | Superiority |
| Change from Baseline at LOCF | t-test, 2 sided | 0.038 | Superiority |
|
| Change from Baseline at Month 9 |
|
|
| Change from Baseline at Month 12 |
|
|
| Change from Baseline at Month 15 |
|
|
| Change from Baseline at Month 18 |
|
|
| Change from Baseline at LOCF |
|
|
| 0.474 |
| Superiority |
| Change from Baseline at Month 9 | t-test, 2 sided | 0.395 | Superiority |
| Change from Baseline at Month 12 | t-test, 2 sided | 0.220 | Superiority |
| Change from Baseline at Month 15 | t-test, 2 sided | 0.454 | Superiority |
| Change from Baseline at Month 18 | t-test, 2 sided | 0.167 | Superiority |
| Change from Baseline at LOCF | t-test, 2 sided | 0.015 | Superiority |
| Revascularization of the index leg |
|
| All-cause death |
|
| No events recorded |
|
| Month 0 to 12 |
|
| Month 0 to 18 |
|
|
| Up to 3M : New ulcer |
|
|
| Up to 3M : Wound infection (new or worsening) |
|
|
| Up to 3M : Amputation due to Worsening CLI |
|
|
| Up to 3M : Peripheral vascular intervention |
|
|
| Up to 3M : Complication vascular intervention |
|
|
| Up to 3M : Cellulitis |
|
|
| Up to 3M : Worsening of ulcer |
|
|
| 3M to 6M : Any CLI-related events |
|
|
| 3M to 6M : Worsening rest pain |
|
|
| 3M to 6M : New ulcer |
|
|
| 3M to 6M : Wound infection (new or worsening) |
|
|
| 3M to 6M : Amputation due to Worsening CLI |
|
|
| 3M to 6M : Peripheral vascular intervention |
|
|
| 3M to 6M : Complication of vascular intervention |
|
|
| 3M to 6M : Cellulitis |
|
|
| 3M to 6M : Worsening of ulcer |
|
|
| 6M to 9M : Any CLI-related events |
|
|
| 6M to 9M : Worsening rest pain |
|
|
| 6M to 9M : New ulcer |
|
|
| 6M to 9M : Wound infection (new or worsening) |
|
|
| Month 6 up to 9 : Amputation due to Worsening CLI |
|
|
| Month 6 up to 9 : Peripheral vascular intervention |
|
|
| 6M to 9M : Complication of vascular intervention |
|
|
| Month 6 up to 9 : Cellulitis |
|
|
| Month 6 up to 9 : Worsening of ulcer |
|
|
| 9M to 12M : Any CLI-related events |
|
|
| Month 9 up to 12 : Worsening rest pain |
|
|
| Month 9 up to 12 : New ulcer |
|
|
| 9M to 12M : Wound infection (new or worsening) |
|
|
| Month 9 up to 12 : Amputation due to Worsening CLI |
|
|
| 9M to 12M : Peripheral vascular intervention |
|
|
| 9M to 12M : Complication of vascular intervention |
|
|
| Month 9 up to 12 : Cellulitis |
|
|
| Month 9 up to 12 : Worsening of ulcer |
|
|
| 12M to 15M : Any CLI-related events |
|
|
| Month 12 up to 15 : Worsening rest pain |
|
|
| Month 12 up to 15 : New ulcer |
|
|
| 12M to 15M : Wound infection (new or worsening) |
|
|
| 12M to 15M : Amputation due to Worsening CLI |
|
|
| 12M to 15M : Peripheral vascular intervention |
|
|
| 12M to 15M : Complication of vascular intervention |
|
|
| Month 12 up to 15 : Cellulitis |
|
|
| Month 12 up to 15 : Worsening of ulcer |
|
|
| 15M to 18M : Any CLI-related events |
|
|
| Month 15 up to 18 : Worsening rest pain |
|
|
| Month 15 up to 18 : New ulcer |
|
|
| 15M to 18M : Wound infection (new or worsening) |
|
|
| 15M to 18M : Amputation due to Worsening CLI |
|
|
| 15M to 18M : Peripheral vascular intervention |
|
|
| 15M to 18M : Complication of vascular intervention |
|
|
| Month 15 up to 18 : Cellulitis |
|
|
| Month 15 up to 18 : Worsening of ulcer |
|
|
| Shift to R3 |
|
| Shift to R4 |
|
| Shift to R5 |
|
| Shift to R6 |
|
| Discontinuation due to Death, AE or CLI Event |
|
| Month 3 to 6 (Baseline R4) |
|
|
| Month 6 to 9 (Baseline R4) |
|
|
| Month 9 to 12 (Baseline R4) |
|
|
| Month 12 to 15 (Baseline R4) |
|
|
| Month 15 to 18 (Baseline R4) |
|
|
| Up to Month 3 (Baseline R5) |
|
|
| Month 3 to 6 (Baseline R5) |
|
|
| Month 6 to 9 (Baseline R5) |
|
|
| Month 9 to 12 (Baseline R5) |
|
|
| Month 12 to 15 (Baseline R5) |
|
|
| Month 15 to 18 (Baseline R5) |
|
|