ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 444 for:    Foot Diseases | "Diabetic Foot"

The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00765063
Recruitment Status : Completed
First Posted : October 2, 2008
Results First Posted : January 13, 2012
Last Update Posted : January 13, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetic Foot Ulcer
Intervention Drug: Fragmin
Enrollment 62
Recruitment Details This was a follow-up study of A6301083 (NCT00662831)
Pre-assignment Details  
Arm/Group Title Dalteparin
Hide Arm/Group Description Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Period Title: Overall Study
Started 62
Completed 30
Not Completed 32
Reason Not Completed
Lack of Efficacy             5
Withdrawal by Subject             1
Other             16
Protocol Violation             6
Adverse Event             4
Arm/Group Title Dalteparin
Hide Arm/Group Description Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Overall Number of Baseline Participants 62
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 62 participants
65.2  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 62 participants
Female
16
  25.8%
Male
46
  74.2%
1.Primary Outcome
Title Number of All Hemorrhages
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were known to have taken at least one dose of the study medication.
Arm/Group Title Dalteparin
Hide Arm/Group Description:
Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Overall Number of Participants Analyzed 62
Measure Type: Number
Unit of Measure: Hemorrhages
3
2.Primary Outcome
Title Number of Major Hemorrhages
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were known to have taken at least one dose of the study medication.
Arm/Group Title Dalteparin
Hide Arm/Group Description:
Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Overall Number of Participants Analyzed 62
Measure Type: Number
Unit of Measure: Hemorrhages
0
3.Primary Outcome
Title Number of Minor Hemorrhages
Hide Description Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.
Time Frame Baseline to Week 24 (EOT) or ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were known to have taken at least one dose of the study medication.
Arm/Group Title Dalteparin
Hide Arm/Group Description:
Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Overall Number of Participants Analyzed 62
Measure Type: Number
Unit of Measure: Hemorrhages
3
4.Primary Outcome
Title Number of Clinically Relevant Minor Hemorrhages
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were known to have taken at least one dose of the study medication.
Arm/Group Title Dalteparin
Hide Arm/Group Description:
Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Overall Number of Participants Analyzed 62
Measure Type: Number
Unit of Measure: Hemorrhages
2
5.Primary Outcome
Title Number of Trivial Hemorrhages
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis population included all participants who were known to have taken at least one dose of the study medication.
Arm/Group Title Dalteparin
Hide Arm/Group Description:
Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Overall Number of Participants Analyzed 62
Measure Type: Number
Unit of Measure: Hemorrhages
1
6.Secondary Outcome
Title Number of Participants With Intact Skin Healing
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population included all participants who were enrolled into the study.
Arm/Group Title Dalteparin
Hide Arm/Group Description:
Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Overall Number of Participants Analyzed 62
Measure Type: Number
Unit of Measure: Participants
19
7.Secondary Outcome
Title Number of Participants With Improved Ulcer Healing
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled into the study.
Arm/Group Title Dalteparin
Hide Arm/Group Description:
Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Overall Number of Participants Analyzed 62
Measure Type: Number
Unit of Measure: Participants
25
8.Secondary Outcome
Title Number of Participants Who Underwent Amputation
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled into the study.
Arm/Group Title Dalteparin
Hide Arm/Group Description:
Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Overall Number of Participants Analyzed 62
Measure Type: Number
Unit of Measure: Participants
All amputations (major and minor) 1
Major Amputation 1
Minor Amputation 0
9.Secondary Outcome
Title Time to Intact Skin Healing
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.
Arm/Group Title Dalteparin
Hide Arm/Group Description:
Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Time to First Amputation
Hide Description [Not Specified]
Time Frame Baseline through Week 24 (EOT) or ET
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.
Arm/Group Title Dalteparin
Hide Arm/Group Description:
Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Number of Participants With Major Cardiovascular Disease Events (MCVE)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The data was not analyzed as planned because the study enrollment was terminated before the planned number of randomized participants was obtained.
Arm/Group Title Dalteparin
Hide Arm/Group Description:
Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title 11-point Likert Pain Scale
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled into the study.
Arm/Group Title Dalteparin
Hide Arm/Group Description:
Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Overall Number of Participants Analyzed 62
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 2.4  (2.1)
EOT 2.2  (2.1)
13.Secondary Outcome
Title 36-Item Short-Form Health Survey (SF-36) Score
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population included all participants who were enrolled into the study. 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.
Arm/Group Title Dalteparin
Hide Arm/Group Description:
Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
Overall Number of Participants Analyzed 62
Mean (Standard Deviation)
Unit of Measure: Units on a scale
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)
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title Dalteparin
Hide Arm/Group Description Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.
All-Cause Mortality
Dalteparin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dalteparin
Affected / at Risk (%)
Total   11/62 (17.74%) 
Blood and lymphatic system disorders   
Anaemia * 1  1/62 (1.61%) 
Cardiac disorders   
Cardiac failure * 1  1/62 (1.61%) 
Cardiac failure acute * 1  1/62 (1.61%) 
Myocardial infarction * 1  1/62 (1.61%) 
Infections and infestations   
Cellulitis * 1  2/62 (3.23%) 
Erysipelas * 1  1/62 (1.61%) 
Gangrene * 1  1/62 (1.61%) 
Infected skin ulcer * 1  1/62 (1.61%) 
Pneumonia * 1  2/62 (3.23%) 
Urinary tract infection * 1  1/62 (1.61%) 
Injury, poisoning and procedural complications   
Fall * 1  1/62 (1.61%) 
Femoral neck fracture * 1  1/62 (1.61%) 
Metabolism and nutrition disorders   
Hypoglycaemia * 1  1/62 (1.61%) 
Musculoskeletal and connective tissue disorders   
Pain in extremity * 1  1/62 (1.61%) 
Nervous system disorders   
Carpal tunnel syndrome * 1  1/62 (1.61%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dalteparin
Affected / at Risk (%)
Total   26/62 (41.94%) 
Blood and lymphatic system disorders   
Anaemia * 1  1/62 (1.61%) 
Cardiac disorders   
Atrial fibrillation * 1  1/62 (1.61%) 
Cardiac failure * 1  2/62 (3.23%) 
Ear and labyrinth disorders   
Vertigo * 1  1/62 (1.61%) 
Endocrine disorders   
Hypothyroidism * 1  1/62 (1.61%) 
Eye disorders   
Panophthalmitis * 1  1/62 (1.61%) 
Gastrointestinal disorders   
Abdominal pain * 1  1/62 (1.61%) 
Diarrhoea * 1  2/62 (3.23%) 
Haemorrhoidal haemorrhage * 1  1/62 (1.61%) 
Nausea * 1  2/62 (3.23%) 
General disorders   
Oedema peripheral * 1  1/62 (1.61%) 
Ulcer haemorrhage * 1  1/62 (1.61%) 
Infections and infestations   
Cystitis * 1  1/62 (1.61%) 
Diabetic foot infection * 1  3/62 (4.84%) 
Erysipelas * 1  2/62 (3.23%) 
Folliculitis * 1  1/62 (1.61%) 
Infected skin ulcer * 1  1/62 (1.61%) 
Nasopharyngitis * 1  4/62 (6.45%) 
Orchitis * 1  1/62 (1.61%) 
Pneumonia * 1  1/62 (1.61%) 
Respiratory tract infection * 1  1/62 (1.61%) 
Tooth infection * 1  1/62 (1.61%) 
Urinary tract infection * 1  1/62 (1.61%) 
Wound infection * 1  1/62 (1.61%) 
Injury, poisoning and procedural complications   
Chest injury * 1  1/62 (1.61%) 
Contusion * 1  2/62 (3.23%) 
Wound * 1  1/62 (1.61%) 
Investigations   
Body temperature increased * 1  1/62 (1.61%) 
Metabolism and nutrition disorders   
Hypertriglyceridaemia * 1  1/62 (1.61%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  2/62 (3.23%) 
Musculoskeletal pain * 1  1/62 (1.61%) 
Osteitis * 1  1/62 (1.61%) 
Psychiatric disorders   
Sleep disorder * 1  1/62 (1.61%) 
Renal and urinary disorders   
Urinary retention * 1  1/62 (1.61%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea * 1  1/62 (1.61%) 
Skin and subcutaneous tissue disorders   
Decubitus ulcer * 1  1/62 (1.61%) 
Diabetic ulcer * 1  2/62 (3.23%) 
Dry gangrene * 1  1/62 (1.61%) 
Skin discolouration * 1  1/62 (1.61%) 
Skin ulcer * 1  4/62 (6.45%) 
Urticaria * 1  1/62 (1.61%) 
Surgical and medical procedures   
Tooth extraction * 1  1/62 (1.61%) 
Vascular disorders   
Circulatory collapse * 1  1/62 (1.61%) 
Hypertensive crisis * 1  1/62 (1.61%) 
Intra-abdominal haematoma * 1  1/62 (1.61%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.1
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is 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.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00765063     History of Changes
Other Study ID Numbers: A6301086
First Submitted: September 30, 2008
First Posted: October 2, 2008
Results First Submitted: August 11, 2011
Results First Posted: January 13, 2012
Last Update Posted: January 13, 2012