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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
276
Pre-filled syringes containing a single dose of 5000 IU Fragmin/ Dalteparin Sodium.
Pre-filled syringes containing a single dose of placebo for 5000 IU Fragmin/ Dalteparin Sodium.
Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing
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.
Time frame: Week 24 [end of treatment (EOT)] or early termination
Number of Participants With Intact Skin Healing
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.
Time frame: Week 24 (EOT) or early termination
Number of Participants Who Underwent Any Amputation
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.
Time frame: Week 24 (EOT) or early termination
Number of Participants Who Underwent Major and Minor Amputation
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.
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Pfizer Investigational Site
Klagenfurt, Austria
Pfizer Investigational Site
Vienna, Austria
Pfizer Investigational Site
Vienna, Austria
Pfizer Investigational Site
Ransart, Belgium
Pfizer Investigational Site
Winnipeg, Manitoba, Canada
Pfizer Investigational Site
Montreal, Quebec, Canada
Pfizer Investigational Site
Prague, Czechia
Pfizer Investigational Site
Prague, Czechia
Pfizer Investigational Site
Zlín, Czechia
Pfizer Investigational Site
Aalborg, Denmark
...and 53 more locations
Time frame: Week 24 (EOT) or early termination
Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Excluding Intact Skin Healing
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.
Time frame: Week 24 (EOT) or early termination
Number of Participants Who Died
Time frame: Week 24 (EOT) or early termination
Number of Participants With Major Cardiovascular Disease Events (MCVE)
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 frame: Week 24 (EOT) or early termination
Time to Intact Skin Healing
Median time taken to achieve intact skin healing which was defined as 100 percent reduction in ulcer surface area with full epithelialisation.
Time frame: Week 24 (EOT) or early termination
Median Time to First Amputation
Time frame: Week 24 (EOT) or early termination
Euro Quality of Life-5 Dimensions (EQ-5D)- Utility Score
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.
Time frame: Baseline and Week 24 (EOT or early termination)
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)
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.
Time frame: Baseline and Week 24 (EOT or early termination)
36-Item Short-Form Health Survey (SF-36) Score
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 early termination)
11-point Likert Pain Scale
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 early termination)
Transcutaneous Local Tissue Oxygenation (pO2)
Transcutaneous pO2 was assessed at the dorsum of the foot in the first intermetatarsal space using an appropriately calibrated instrument. The skin oxygen partial pressure was determined by measuring the oxygen reduction current by means of a measuring cell.
Time frame: Baseline and Week 24 (EOT or early termination)