A Phase 2/3 interventional study of Fragmin in Diabetic Foot Ulcer, sponsored by Pfizer. Completed at 27 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-13.
Sponsored by Pfizer · Phase 2/3, Interventional, and Treatment
The primary objective of this 6 month open-label extension trial is to evaluate long-term safety and tolerability of dalteparin in treatment of chronic neuroischaemic foot ulcers in diabetic patients with peripheral arterial occlusive disease (PAOD) and peripheral neuropathy.
1,054 studies on the registry are indexed under Diabetic Foot; 222 are open to participants now.
This study's enrollment of 62 is close to the median of 60 across 826 interventional studies indexed under Diabetic Foot.
Browse Diabetic Foot studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Active study treatment
Drug: Fragmin
Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium
Also known as: Dalteparin sodium
Number of All Hemorrhages
Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 gram (g)/litre (L) (2 g/ decilitre \[dL\]), clinically overt bleeding leading to transfusion of greater 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.
Time frame: Baseline to Week 24 (end of treatment [EOT]) or early termination (ET)
Number of Major Hemorrhages
Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 g/L (2 g/dL), clinically overt bleeding leading to transfusion of greater 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).
Time frame: Baseline to Week 24 (EOT) or ET
Number of Minor Hemorrhages
Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.
Time frame: Baseline to Week 24 (EOT) or ET
Number of Clinically Relevant Minor 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.
Time frame: Baseline to Week 24 (EOT) or ET
Number of Trivial Hemorrhages
Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding.
Time frame: Baseline to Week 24 (EOT) or ET
Number of Participants With Intact Skin Healing
Intact skin healing was defined as 100 percent reduction in ulcer surface area with full epithelialisation. The ulcer area was measured in square millimetre (mm) by measuring the longest width and length of the ulcer after debridement. The area was calculated from an acetate tracing. Ulcers were also documented by standardized photographs. The largest ulcer was considered the study ulcer in participants with multiple ulcers.
Time frame: Baseline through Week 24 (EOT) or ET
Number of Participants With Improved Ulcer Healing
Improved ulcer healing was defined as greater than or equal to 50 percent reduction in ulcer surface area from baseline of the A6301083 study excluding intact skin healing. The ulcer area was measured in square mm by measuring the longest width and length of the ulcer after debridement. Ulcers were also documented by standardized photographs.
Time frame: Baseline through Week 24 (EOT) or ET
Number of Participants Who Underwent 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.
Time frame: Baseline through Week 24 (EOT) or ET
Time to Intact Skin Healing
Median time (in months) taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation.
Time frame: Baseline through Week 24 (EOT) or ET
Time to First Amputation
Time frame: Baseline through Week 24 (EOT) or ET
Number of Participants With Major Cardiovascular Disease Events (MCVE)
MCVE 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.
Time frame: Baseline through Week 24 (EOT) or ET
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.
Time frame: Baseline and Week 24 (EOT) or ET
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).
Time frame: Baseline and Week 24 (EOT) or ET
This was a follow-up study of A6301083 (NCT00662831)
| Milestone | Dalteparin |
|---|---|
| Started | 62 |
| Completed | 30 |
| Not completed | 32 |
| Withdrew: Lack of efficacy | 5 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Other | 16 |
| Withdrew: Protocol violation | 6 |
| Withdrew: Adverse event | 4 |
Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 gram (g)/litre (L) (2 g/ decilitre \[dL\]), clinically overt bleeding leading to transfusion of greater 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.
| Hemorrhages | Dalteparin |
|---|---|
| Number of All Hemorrhages | 3 |
Major hemorrhages: defined as fatal bleeding, clinically overt bleeding causing a fall in hemoglobin greater than or equal to 20 g/L (2 g/dL), clinically overt bleeding leading to transfusion of greater 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).
| Hemorrhages | Dalteparin |
|---|---|
| Number of Major Hemorrhages | 0 |
Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.
| Hemorrhages | Dalteparin |
|---|---|
| Number of Minor Hemorrhages | 3 |
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.
| Hemorrhages | Dalteparin |
|---|---|
| Number of Clinically Relevant Minor Hemorrhages | 2 |
Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding.
| Hemorrhages | Dalteparin |
|---|---|
| Number of Trivial Hemorrhages | 1 |
Intact skin healing was defined as 100 percent reduction in ulcer surface area with full epithelialisation. The ulcer area was measured in square millimetre (mm) by measuring the longest width and length of the ulcer after debridement. The area was calculated from an acetate tracing. Ulcers were also documented by standardized photographs. The largest ulcer was considered the study ulcer in participants with multiple ulcers.
| Participants | Dalteparin |
|---|---|
| Number of Participants With Intact Skin Healing | 19 |
Improved ulcer healing was defined as greater than or equal to 50 percent reduction in ulcer surface area from baseline of the A6301083 study excluding intact skin healing. The ulcer area was measured in square mm by measuring the longest width and length of the ulcer after debridement. Ulcers were also documented by standardized photographs.
| Participants | Dalteparin |
|---|---|
| Number of Participants With Improved Ulcer Healing | 25 |
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.
| Participants | Dalteparin |
|---|---|
| All amputations (major and minor) | 1 |
| Major Amputation | 1 |
| Minor Amputation | 0 |
Median time (in months) taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
MCVE 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.
No measurements were reported for this outcome.
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.
| Units on a scale | Dalteparin |
|---|---|
| Baseline | 2.4 ± 2.1 |
| EOT | 2.2 ± 2.1 |
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).
| Units on a scale | Dalteparin |
|---|---|
| Baseline: Physical Functioning (n= 43) | 34.7 ± 11.7 |
| Baseline: Role-Physical (n= 43) | 36.5 ± 10.7 |
| Baseline: Bodily Pain (n= 43) | 45.1 ± 9.6 |
| Baseline: General Health (n= 43) | 44.1 ± 4.5 |
| Baseline: Visibility (n= 43) | 48.1 ± 5.7 |
| Baseline: Social Functioning (n= 43) | 34.3 ± 7.6 |
| Baseline: Role-Emotional (n= 43) | 36.6 ± 13.8 |
| Baseline: Mental Health (n= 43) | 42.1 ± 6.4 |
| Baseline: Physical (PCS) (n= 43) | 40.1 ± 7.7 |
| Baseline: Mental (MCS) (n= 43) | 41.4 ± 7.2 |
| EOT: Physical Functioning (n= 57) | 34.8 ± 11.2 |
| EOT: Role-Physical (n= 57) | 35.1 ± 11.0 |
| EOT: Bodily Pain (n= 57) | 45.5 ± 11.3 |
| EOT: General Health (n= 57) | 42.9 ± 4.6 |
| EOT: Visibility (n= 57) | 48.7 ± 6.3 |
| EOT: Social Functioning (n= 57) | 35.1 ± 4.5 |
| EOT: Role-Emotional (n= 57) | 36.3 ± 14.9 |
| EOT: Mental Health (n= 57) | 42.2 ± 7.1 |
| EOT: Physical (PCS) (n= 57) | 39.4 ± 9.0 |
| EOT: Mental (MCS) (n= 57) | 41.9 ± 7.9 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dalteparin | — | 11/62 (17.7%) | 26/62 (41.9%) |
| Event | Dalteparin |
|---|---|
| CellulitisInfections and infestations | 2/62 |
| PneumoniaInfections and infestations | 2/62 |
| AnaemiaBlood and lymphatic system disorders | 1/62 |
| Cardiac failureCardiac disorders | 1/62 |
| Cardiac failure acuteCardiac disorders | 1/62 |
| Myocardial infarctionCardiac disorders | 1/62 |
| ErysipelasInfections and infestations | 1/62 |
| GangreneInfections and infestations | 1/62 |
| Infected skin ulcerInfections and infestations | 1/62 |
| Urinary tract infectionInfections and infestations | 1/62 |
| Event | Dalteparin |
|---|---|
| NasopharyngitisInfections and infestations | 4/62 |
| Skin ulcerSkin and subcutaneous tissue disorders | 4/62 |
| Diabetic foot infectionInfections and infestations | 3/62 |
| Cardiac failureCardiac disorders | 2/62 |
| DiarrhoeaGastrointestinal disorders | 2/62 |
| NauseaGastrointestinal disorders | 2/62 |
| ErysipelasInfections and infestations | 2/62 |
| ContusionInjury, poisoning and procedural complications | 2/62 |
| Back painMusculoskeletal and connective tissue disorders | 2/62 |
| Diabetic ulcerSkin and subcutaneous tissue disorders | 2/62 |
| Age Continuous(years) | Dalteparin |
|---|---|
| Mean | 65.2 ± 11.0 |
| Sex: Female, Male(Participants) | Dalteparin |
|---|---|
| Female | 16 |
| Male | 46 |
This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
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