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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Drug: Fragmin Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 6 Month, Prospective, Open-Label Multiple Center Extension Trial To Evaluate The Long Term Safety And Sustained Efficacy Of Fragmin In The Treatment Of Chronic Foot Ulcers In Diabetic Patients With Peripheral Arterial Occlusive Disease
Study Start Date : October 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active
Active study treatment
Drug: Fragmin
Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium
Other Name: Dalteparin sodium




Primary Outcome Measures :
  1. Number of All Hemorrhages [ Time Frame: Baseline to Week 24 (end of treatment [EOT]) or early termination (ET) ]
    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.

  2. Number of Major Hemorrhages [ Time Frame: Baseline to Week 24 (EOT) or ET ]
    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).

  3. Number of Minor Hemorrhages [ Time Frame: Baseline to Week 24 (EOT) or ET ]
    Minor hemorrhages: defined as bleeding that did not meet the definition of major bleeding.

  4. Number of Clinically Relevant Minor Hemorrhages [ Time Frame: Baseline to Week 24 (EOT) or ET ]
    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.

  5. Number of Trivial Hemorrhages [ Time Frame: Baseline to Week 24 (EOT) or ET ]
    Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding.


Secondary Outcome Measures :
  1. Number of Participants With Intact Skin Healing [ Time Frame: Baseline through Week 24 (EOT) or ET ]
    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.

  2. Number of Participants With Improved Ulcer Healing [ Time Frame: Baseline through Week 24 (EOT) or ET ]
    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.

  3. Number of Participants Who Underwent Amputation [ Time Frame: Baseline through Week 24 (EOT) or ET ]
    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.

  4. Time to Intact Skin Healing [ Time Frame: Baseline through Week 24 (EOT) or ET ]
    Median time (in months) taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation.

  5. Time to First Amputation [ Time Frame: Baseline through Week 24 (EOT) or ET ]
  6. Number of Participants With Major Cardiovascular Disease Events (MCVE) [ Time Frame: Baseline through Week 24 (EOT) or ET ]
    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.

  7. 11-point Likert Pain Scale [ Time Frame: Baseline and Week 24 (EOT) or ET ]
    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.

  8. 36-Item Short-Form Health Survey (SF-36) Score [ Time Frame: Baseline and Week 24 (EOT) or ET ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have completed the 6 month study duration in the A6301083 study.
  • Subjects must have a positive ulcer treatment response, defined as a reduction in the study ulcer area size (ie, ulcer area reduction >0%) at Visit 8 (EOT Visit) from baseline in the A6301083 study.
  • All ulcers must have an ulcer staging of 1C, 2C, 1D or 2D according to the University of Texas wound classification system

Exclusion Criteria:

  • Subjects who have the following:
  • Intact skin healing (defined as 100% reduction in ulcer surface area with full epithelialisation at or prior to the EOT visit in the A6301083 study).
  • A study ulcer area at Visit 8 (EOT visit) which is greater or equal to the baseline ulcer area (ie, ulcer area increase ≥0%) in the A6301083 study.
  • Subjects with an ulcer grading of 0 or 3 or staging of A or B according to the University of Texas wound classification system.
  • Subjects with a known bleeding disorder or evidence of active bleeding.
  • Subjects who are on dialysis.
  • Subjects who where found to be major protocol violators in A6301083 study.
  • Subjects who did not complete the 6 month study period of the A6301083 study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00765063


Locations
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Austria
Pfizer Investigational Site
Wien, Austria, A-1090
Belgium
Pfizer Investigational Site
Ransart, Belgium, 6043
Canada, Manitoba
Pfizer Investigational Site
Winnipeg, Manitoba, Canada, R3A 1R9
Czech Republic
Pfizer Investigational Site
Praha 5, Czech Republic, 150 06
Pfizer Investigational Site
Zlin, Czech Republic, 760 01
Denmark
Pfizer Investigational Site
Aarhus C, Denmark, 8000
Germany
Pfizer Investigational Site
Karlsbad, Germany, 76307
Greece
Pfizer Investigational Site
Melissia/Athens, Greece, 15127
Italy
Pfizer Investigational Site
Firenze, Italy, 50139
Norway
Pfizer Investigational Site
Tonsberg, Norway, 3103
Poland
Pfizer Investigational Site
Lodz, Poland, 90-153
Pfizer Investigational Site
Pulawy, Poland, 24-100
Pfizer Investigational Site
Warszawa, Poland, 02-097
Pfizer Investigational Site
Wroclaw, Poland, 51-124
Russian Federation
Pfizer Investigational Site
Moscow, Russia, Russian Federation, 119034
Pfizer Investigational Site
Moscow, Russian Federation, 123423
Pfizer Investigational Site
Moscow, Russian Federation, 127486
Pfizer Investigational Site
Saint-Petersburg, Russian Federation, 194156
Sweden
Pfizer Investigational Site
Karlstad, Sweden, 651 85
Pfizer Investigational Site
Malmo, Sweden, 205 02
Pfizer Investigational Site
Stockholm, Sweden, 118 83
Pfizer Investigational Site
Stockholm, Sweden, 171 76
Pfizer Investigational Site
Stockholm, Sweden, 182 88
Ukraine
Pfizer Investigational Site
Kharkiv, Ukraine, 61002
Pfizer Investigational Site
Kyiv, Ukraine, 02091
Pfizer Investigational Site
Lviv, Ukraine, 79010
United Kingdom
Pfizer Investigational Site
Birmingham, United Kingdom, B9 5SS
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00765063    
Other Study ID Numbers: A6301086
First Posted: October 2, 2008    Key Record Dates
Results First Posted: January 13, 2012
Last Update Posted: January 13, 2012
Last Verified: December 2011
Keywords provided by Pfizer:
Diabetic Foot Ulcers Neuroischaemic
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases
Dalteparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action