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The purpose of the study isto see the effect of Fragmin on the healing of diabetic foot ulcers by determining the number of subjects with ≥50% reduction in ulcer surface area including intact skin healing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Active study treatment |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fragmin/ Dalteparin Sodium | Drug | Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing | University of Texas (UT) system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. UT Wound Classification (1C/2C) was based on grade (0= healed site to 3= penetrating wound to bone or joint) and stage (A= clean wounds to D= ischaemic infected wounds) of wounds. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C. | Week 24 [end of treatment (EOT)] or early termination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Intact Skin Healing | Intact skin healing was defined as 100 percent reduction in ulcer surface area with full epithelialisation. UT system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of All Hemorrhages | Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin more than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of more than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Klagenfurt | A-9020 | Austria | |||
| Pfizer Investigational Site |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dalteparin | Dalteparin 5000 International Units (IU) (0.2 milliliter [mL]) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET). |
| FG001 | Placebo | Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo for Fragmin/ Dalteparin Sodium | Drug | Pre-filled syringes containing a single dose of placebo for 5000 IU Fragmin/ Dalteparin Sodium. |
|
| Week 24 (EOT) or early termination |
| Number of Participants Who Underwent Any Amputation | Any amputation included both major and minor amputations. A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation. | Week 24 (EOT) or early termination |
| Number of Participants Who Underwent Major and Minor Amputation | A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation. | Week 24 (EOT) or early termination |
| Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Excluding Intact Skin Healing | University of Texas (UT) system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. UT Wound Classification (1C/2C) was based on grade (0= healed site to 3= penetrating wound to bone or joint) and stage (A= clean wounds to D= ischaemic infected wounds) of wounds. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C. | Week 24 (EOT) or early termination |
| Number of Participants Who Died | Week 24 (EOT) or early termination |
| Number of Participants With Major Cardiovascular Disease Events (MCVE) | Major cardiovascular events were defined as death due to vascular cause; non-fatal myocardial infarction (MI) excluding procedure related to MI; coronary revascularization procedures not related to MIs; hospitalization for unstable angina or non-fatal stroke. | Week 24 (EOT) or early termination |
| Time to Intact Skin Healing | Median time taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation. | Week 24 (EOT) or early termination |
| Median Time to First Amputation | Week 24 (EOT) or early termination |
| Euro Quality of Life-5 Dimensions (EQ-5D)- Utility Score | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. It assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. | Baseline and Week 24 (EOT or early termination) |
| Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. | Baseline and Week 24 (EOT or early termination) |
| 36-Item Short-Form Health Survey (SF-36) Score | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). | Baseline and Week 24 (EOT or early termination) |
| 11-point Likert Pain Scale | The 11 point Likert pain scale which used a 0 (no pain) to 10 (worst possible pain) point rating system was used to assess participant's pain score. No distinction was made between neuropathy and inflammatory (nociceptive) pain. | Baseline and Week 24 (EOT or early termination) |
| Transcutaneous Local Tissue Oxygenation (pO2) | Transcutaneous pO2 was assessed at the dorsum of the foot in the first intermetatarsal space using an appropriately calibrated instrument. The skin oxygen partial pressure was determined by measuring the oxygen reduction current by means of a measuring cell. | Baseline and Week 24 (EOT or early termination) |
| Week 24 (EOT) or early termination |
| Number of Major and Minor Hemorrhages | Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin more than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of more than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding. | Week 24 (EOT) or early termination |
| Number of Clinically Relevant Minor Hemorrhages and Trivial Hemorrhages | Clinically relevant minor (non-major) bleeding was defined as any bleeding compromising hemodynamics, leading to hospitalization, subcutaneous haematoma more than 25 cm^2, intramuscular haematoma, epistaxis lasting for more than 5 minutes, spontaneous gingival bleeding, macroscopic hematuria and gastrointestinal hemorrhage (including at least 1 episode of melaena or hematemesis), rectal blood loss, hemoptysis, and any other bleeding with clinical consequences. Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding. | Week 24 (EOT) or early termination |
| Vienna |
| A-1030 |
| Austria |
| Pfizer Investigational Site | Vienna | A-1090 | Austria |
| Pfizer Investigational Site | Ransart | 6043 | Belgium |
| Pfizer Investigational Site | Winnipeg | Manitoba | R3A 1R9 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H1T 2M4 | Canada |
| Pfizer Investigational Site | Prague | 140 21 | Czechia |
| Pfizer Investigational Site | Prague | 150 06 | Czechia |
| Pfizer Investigational Site | Zlín | 760 01 | Czechia |
| Pfizer Investigational Site | Aalborg | 9100 | Denmark |
| Pfizer Investigational Site | Aarhus C | 8000 | Denmark |
| Pfizer Investigational Site | Hvidovre | 2650 | Denmark |
| Pfizer Investigational Site | Koebenhavn NV | 2400 | Denmark |
| Pfizer Investigational Site | Odense C | 5000 | Denmark |
| Pfizer Investigational Site | Sønderborg | 6400 | Denmark |
| Pfizer Investigational Site | Tampere | 33520 | Finland |
| Pfizer Investigational Site | Karlsbad | 76307 | Germany |
| Pfizer Investigational Site | Athens | 106 76 | Greece |
| Pfizer Investigational Site | Athens | 11527 | Greece |
| Pfizer Investigational Site | Melissia/Athens | 15127 | Greece |
| Pfizer Investigational Site | Thessaloniki | 56429 | Greece |
| Pfizer Investigational Site | San Giovanni Rotondo | FG | 71013 | Italy |
| Pfizer Investigational Site | Florence | 50139 | Italy |
| Pfizer Investigational Site | Pisa | 56124 | Italy |
| Pfizer Investigational Site | Roma | 00133 | Italy |
| Pfizer Investigational Site | Kaunas | 49476 | Lithuania |
| Pfizer Investigational Site | Vilnius | 01102 | Lithuania |
| Pfizer Investigational Site | Vilnius | 10207 | Lithuania |
| Pfizer Investigational Site | Tønsberg | 3103 | Norway |
| Pfizer Investigational Site | Gdansk | 80-952 | Poland |
| Pfizer Investigational Site | Lodz | 90-153 | Poland |
| Pfizer Investigational Site | Puławy | 24-100 | Poland |
| Pfizer Investigational Site | Warsaw | 02-097 | Poland |
| Pfizer Investigational Site | Wroclaw | 51-124 | Poland |
| Pfizer Investigational Site | Moscow | 109240 | Russia |
| Pfizer Investigational Site | Moscow | 115998 | Russia |
| Pfizer Investigational Site | Moscow | 119034 | Russia |
| Pfizer Investigational Site | Moscow | 123423 | Russia |
| Pfizer Investigational Site | Moscow | 127486 | Russia |
| Pfizer Investigational Site | Saint Petersburg | 194156 | Russia |
| Pfizer Investigational Site | Getafe | Madrid | 28905 | Spain |
| Pfizer Investigational Site | Girona | 17007 | Spain |
| Pfizer Investigational Site | Madrid | 28040 | Spain |
| Pfizer Investigational Site | Karlstad | 651 85 | Sweden |
| Pfizer Investigational Site | Malmö | 205 02 | Sweden |
| Pfizer Investigational Site | Stockholm | 11883 | Sweden |
| Pfizer Investigational Site | Stockholm | 141 86 | Sweden |
| Pfizer Investigational Site | Stockholm | 17176 | Sweden |
| Pfizer Investigational Site | Stockholm | 182 88 | Sweden |
| Pfizer Investigational Site | Stockholm | 18288 | Sweden |
| Pfizer Investigational Site | Kharkiv | 61002 | Ukraine |
| Pfizer Investigational Site | Kyiv | 02091 | Ukraine |
| Pfizer Investigational Site | Lviv | 79010 | Ukraine |
| Pfizer Investigational Site | Odesa | 65009 | Ukraine |
| Pfizer Investigational Site | Barnsley | S75 2EP | United Kingdom |
| Pfizer Investigational Site | Birmingham | B9 5SS | United Kingdom |
| Pfizer Investigational Site | Colchester | CO4 5JL | United Kingdom |
| Pfizer Investigational Site | Coventry | CV2 2DX | United Kingdom |
| Pfizer Investigational Site | Dundee | DD1 9SY | United Kingdom |
| Pfizer Investigational Site | Ipswich | IP4 5PD | United Kingdom |
| Pfizer Investigational Site | Manchester | M13 0JE | United Kingdom |
| Pfizer Investigational Site | Manchester | M13 9WL | United Kingdom |
| Pfizer Investigational Site | Peterborough | PE3 9GZ | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dalteparin | Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET). |
| BG001 | Placebo | Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | 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 Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing | University of Texas (UT) system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. UT Wound Classification (1C/2C) was based on grade (0= healed site to 3= penetrating wound to bone or joint) and stage (A= clean wounds to D= ischaemic infected wounds) of wounds. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C. | Intention to treat (ITT) population included all participants who were randomized. Last observation carried forward (LOCF) method was used. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively. | Posted | Number | participants | Week 24 [end of treatment (EOT)] or early termination |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Intact Skin Healing | Intact skin healing was defined as 100 percent reduction in ulcer surface area with full epithelialisation. UT system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C. | ITT population included all participants who were randomized. LOCF method was used. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively. | Posted | Number | participants | Week 24 (EOT) or early termination |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Underwent Any Amputation | Any amputation included both major and minor amputations. A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation. | ITT population included all participants who were randomized. | Posted | Number | participants | Week 24 (EOT) or early termination |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Underwent Major and Minor Amputation | A major amputation was defined as above the ankle and was reported as below-the-knee and above-the-knee amputations. A minor amputation was defined as below the ankle amputation. | ITT population included all participants who were randomized. | Posted | Number | participants | Week 24 (EOT) or early termination |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Excluding Intact Skin Healing | University of Texas (UT) system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. UT Wound Classification (1C/2C) was based on grade (0= healed site to 3= penetrating wound to bone or joint) and stage (A= clean wounds to D= ischaemic infected wounds) of wounds. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C. | ITT population included all participants who were randomized. LOCF method was used. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively. | Posted | Number | participants | Week 24 (EOT) or early termination |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Died | ITT population included all participants who were randomized. | Posted | Number | participants | Week 24 (EOT) or early termination |
|
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Major Cardiovascular Disease Events (MCVE) | Major cardiovascular events were defined as death due to vascular cause; non-fatal myocardial infarction (MI) excluding procedure related to MI; coronary revascularization procedures not related to MIs; hospitalization for unstable angina or non-fatal stroke. | The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained. | Posted | Week 24 (EOT) or early termination |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Intact Skin Healing | Median time taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation. | The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained. | Posted | Week 24 (EOT) or early termination |
|
| |||||||||||||||||||||||||||||||||||||||
| Secondary | Median Time to First Amputation | The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained. | Posted | Week 24 (EOT) or early termination |
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Euro Quality of Life-5 Dimensions (EQ-5D)- Utility Score | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. It assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. | ITT population included all participants who were randomized. Participants were only considered when all items contributing to the score had been answered. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 24 (EOT or early termination) |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) | EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. | ITT population included all participants who were randomized. Participants were only considered when all items contributing to the score had been answered. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively. | Posted | Mean | Standard Deviation | mm | Baseline and Week 24 (EOT or early termination) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 36-Item Short-Form Health Survey (SF-36) Score | SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning). | ITT population included all participants who were randomized. This was calculated only when more than half of the questions within dimension were answered. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 24 (EOT or early termination) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | 11-point Likert Pain Scale | The 11 point Likert pain scale which used a 0 (no pain) to 10 (worst possible pain) point rating system was used to assess participant's pain score. No distinction was made between neuropathy and inflammatory (nociceptive) pain. | ITT population included all participants who were randomized. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 24 (EOT or early termination) |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Transcutaneous Local Tissue Oxygenation (pO2) | Transcutaneous pO2 was assessed at the dorsum of the foot in the first intermetatarsal space using an appropriately calibrated instrument. The skin oxygen partial pressure was determined by measuring the oxygen reduction current by means of a measuring cell. | ITT population included all participants who were randomized. Participants were analyzed at selected sites only, based on availability. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 24 (EOT or early termination) |
|
| ||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of All Hemorrhages | Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin more than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of more than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding. | Safety analysis population included all participants who were known to have taken at least one dose of the study medication. | Posted | Number | hemorrhages | Week 24 (EOT) or early termination |
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Major and Minor Hemorrhages | Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin more than or equal to 20 gram (g)/litre (L) (2 g/ decilitre [dL]), clinically overt bleeding leading to transfusion of more than or equal to 2 units of whole blood or red cells, or symptomatic bleeding in areas of special concern (intracranial, retroperitoneal, intraocular, intraspinal, pericardial, intramuscular with compartmental syndrome, or intraarticular). Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding. | Safety analysis population included all participants who were known to have taken at least one dose of the study medication. | Posted | Number | hemorrhages | Week 24 (EOT) or early termination |
|
| |||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Clinically Relevant Minor Hemorrhages and Trivial Hemorrhages | Clinically relevant minor (non-major) bleeding was defined as any bleeding compromising hemodynamics, leading to hospitalization, subcutaneous haematoma more than 25 cm^2, intramuscular haematoma, epistaxis lasting for more than 5 minutes, spontaneous gingival bleeding, macroscopic hematuria and gastrointestinal hemorrhage (including at least 1 episode of melaena or hematemesis), rectal blood loss, hemoptysis, and any other bleeding with clinical consequences. Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding. | Safety analysis population included all participants who were known to have taken at least one dose of the study medication. | Posted | Number | hemorrhages | Week 24 (EOT) or early termination |
|
|
Not provided
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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 | Dalteparin | Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET). | 33 | 184 | 76 | 184 | ||
| EG001 | Placebo | Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET. | 18 | 92 | 36 | 92 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Trifascicular block | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Colonic stenosis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Ulcer | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Arteriosclerotic gangrene | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Diabetic foot | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Strangury | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Diabetic ulcer | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Venous thrombosis | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Anaemia of chronic disease | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Monocytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Bundle branch block left | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Eye haemorrhage | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Abdominal rigidity | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Erosive duodenitis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Retching | Gastrointestinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Inflammation | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Oedema | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Ulcer | General disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Liver disorder | Hepatobiliary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Diabetic foot infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Infected skin ulcer | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Localised infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Lymphangitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Orchitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Osteomyelitis chronic | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Wound infection | Infections and infestations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Traumatic haematoma | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA 13.1 | Non-systematic Assessment |
| |
| Antibiotic resistant Staphylococcus test positive | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Bacterial test positive | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Blood albumin decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Blood glucose abnormal | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Fibrin D dimer increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Heart rate decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 13.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Diabetic foot | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| IIIrd nerve paralysis | Nervous system disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Generalised anxiety disorder | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Diabetic nephropathy | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Urinary tract disorder | Renal and urinary disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Genital haemorrhage | Reproductive system and breast disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Blood blister | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Diabetic ulcer | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Skin lesion | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Skin ulcer haemorrhage | Skin and subcutaneous tissue disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 13.1 | Non-systematic Assessment |
|
Study enrollment was terminated before planned number of participants was obtained. Although randomized participants were allowed to complete entire course of therapy according to protocol and study status was therefore designated as completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
Not provided
Not provided
| ID | Term |
|---|---|
| D017985 | Dalteparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
Not provided
Not provided
| Male |
|
| Stratum 3 (n= 29, 14) |
|
| Stratum 4 (n= 19, 10) |
|
| Participants |
|
|
|
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Participants |
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