Clinical Trial: Study Of The Effect Of Fragmin In The Treatment Of Neuroischaemic Foot Ulcers In Diabetic Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A 6 Month, Prospective, Randomized, Double Blind, Placebo-Controlled, Parallel Group, Multiple Center Trial To Evaluate The Efficacy And Safety Of Fragmin In The Treatment Of Chronic Neuroischaemic

Brief Summary: The purpose of the study isto see the effect of Fragmin on the healing of diabetic foot ulcers by determining the number of subjects with ≥50% reduction in ulcer surface area including intact skin healing.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome: Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing [ Time Frame: Week 24 [end of treatment (EOT)] or early termination ]

University of Texas (UT) system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. UT Wound Classification (1C/2C) was based on grade (0= healed site to 3= penetrating wound to bone or joint) and stage (A= clean wounds to D= ischaemic infected wounds) of wounds. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C.


Original Primary Outcome: Number of subjects with ≥50% reduction in ulcer surface area including intact skin healing. [ Time Frame: 6 months ]

Current Secondary Outcome:

  • Number of Participants With Intact Skin Healing [ Time Frame: Week 24 (EOT) or early termination ]
    Intact skin healing was defined as 100 percent reduction in ulcer surface area with full epithelialisation. UT system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C.
  • Number of Participants Who Underwent Any Amputation [ Time Frame: Week 24 (EOT) or early termination ]
    Any amputation included both major and minor amputations. 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.
  • Number of Participants Who Underwent Major and Minor Amputation [ Time Frame: Week 24 (EOT) or early termination ]
    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.
  • Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Excluding Intact Skin Healing [ Time Frame: Week 24 (EOT) or early termination ]
    University of Texas (UT) system assesses ulcer depth, wound infection and clinical signs of lower-extremity ischemia. UT Wound Classification (1C/2C) was based on grade (0= healed site to 3= penetrating wound to bone or joint) and stage (A= clean wounds to D= ischaemic infected wounds) of wounds. Participants were evaluated at 4 stratums: Stratum 1: Toe pressure>30 mm of mercury (mmHg) and UT grade and stage 1C. Stratum 2: Toe pressure<=30 mmHg and UT grade and stage 1C. Stratum 3: Toe pressure>30 mmHg and UT grade and stage 2C. Stratum 4: Toe pressure<=30 mmHg and UT grade and stage 2C.
  • Number of Participants Who Died [ Time Frame: Week 24 (EOT) or early termination ]
  • Number of Participants With Major Cardiovascular Disease Events (MCVE) [ Time Frame: Week 24 (EOT) or early termination ]
    Major cardiovascular events 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 to Intact Skin Healing [ Time Frame: Week 24 (EOT) or early termination ]
    Median time taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation.
  • Median Time to First Amputation [ Time Frame: Week 24 (EOT) or early termination ]
  • Euro Quality of Life-5 Dimensions (EQ-5D)- Utility Score [ Time Frame: Baseline and Week 24 (EOT or early termination) ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. It assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (eg, "confined to bed"). Scoring formula developed by EuroQol Group assigns a utility value for each domain in profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
  • Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS) [ Time Frame: Baseline and Week 24 (EOT or early termination) ]
    EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
  • 36-Item Short-Form Health Survey (SF-36) Score [ Time Frame: Baseline and Week 24 (EOT or early termination) ]
    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).
  • 11-point Likert Pain Scale [ Time Frame: Baseline and Week 24 (EOT or early termination) ]
    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.
  • Transcutaneous Local Tissue Oxygenation (pO2) [ Time Frame:&

    Original Secondary Outcome:

    • Number of subjects who have intact skin healing. [ Time Frame: 6 months ]
    • Number of patients who underwent amputation (major and minor). [ Time Frame: 6 months ]


    Information By: Pfizer

    Dates:
    Date Received: April 16, 2008
    Date Started: April 2008
    Date Completion:
    Last Updated: December 1, 2011
    Last Verified: December 2011