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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00765063
First received: September 30, 2008
Last updated: December 1, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Diabetic Foot Ulcer
Drug: Fragmin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of All Hemorrhages [ Time Frame: Baseline to Week 24 (end of treatment [EOT]) or early termination (ET) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Trivial bleeding was defined as all minor bleeding that did not meet the definition of clinically relevant minor bleeding.


Secondary Outcome Measures:
  • Number of Participants With Intact Skin Healing [ Time Frame: Baseline through Week 24 (EOT) or ET ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Number of Participants With Major Cardiovascular Disease Events (MCVE) [ Time Frame: Baseline through Week 24 (EOT) or ET ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Enrollment: 62
Study Start Date: October 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Active study treatment
Drug: Fragmin
Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium
Other Name: Dalteparin sodium

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765063

  Show 27 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00765063     History of Changes
Other Study ID Numbers: A6301086
Study First Received: September 30, 2008
Results First Received: August 11, 2011
Last Updated: December 1, 2011
Health Authority: Spain: Ethics Committee

Keywords provided by Pfizer:
Diabetic Foot Ulcers Neuroischaemic

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Ulcer
Foot Ulcer
Diabetic Foot
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 21, 2014