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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

Tracking Information
First Submitted Date  ICMJE September 30, 2008
First Posted Date  ICMJE October 2, 2008
Results First Submitted Date  ICMJE August 11, 2011
Results First Posted Date  ICMJE January 13, 2012
Last Update Posted Date January 13, 2012
Study Start Date  ICMJE October 2008
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2011)
  • 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.
  • 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).
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 30, 2008)
  • The number of minor hemorrhages. [ Time Frame: 6 months ]
  • The number of clinically relevant minor hemorrhages. [ Time Frame: 6 months ]
  • The number of minor trivial hemorrhages. [ Time Frame: 6 months ]
  • The number of major hemorrhages. [ Time Frame: 6 months ]
  • The number of all hemorrhages (this includes minor and major; see bleeding definition in [ Time Frame: 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2011)
  • 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.
  • 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.
  • 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.
  • 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.
  • Time to First Amputation [ Time Frame: Baseline through Week 24 (EOT) or ET ]
  • 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.
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2008)
  • Number of subjects who have intact skin healing. [ Time Frame: 6 months ]
  • Number of subjects with improved ulcer healing. [ Time Frame: 6 months ]
  • Number of subjects who underwent major amputation [ Time Frame: 6 months ]
  • Number of subjects who underwent minor amputation. [ Time Frame: 6 months ]
  • Time to healing [ Time Frame: 6 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients (A6301086)
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Foot Ulcer
Intervention  ICMJE Drug: Fragmin
Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium
Other Name: Dalteparin sodium
Study Arms  ICMJE Experimental: Active
Active study treatment
Intervention: Drug: Fragmin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 24, 2011)
62
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2008)
215
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Canada,   Czech Republic,   Denmark,   Germany,   Greece,   Italy,   Norway,   Poland,   Russian Federation,   Sweden,   Ukraine,   United Kingdom
Removed Location Countries Lithuania,   Spain
 
Administrative Information
NCT Number  ICMJE NCT00765063
Other Study ID Numbers  ICMJE A6301086
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP