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

Phase 2

Completed

• Conditions: Diabetic Foot Ulcer
• Interventions: Drug: Placebo for Fragmin/ Dalteparin Sodium; Drug: Fragmin/ Dalteparin Sodium

• Registration Number: NCT00662831
• Lead Sponsor: Pfizer

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 Description

Not available

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-16
• Study First Submitted QC: 2008-04-17
• Study First Posted: 2008-04-21
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Results First Submitted: 2011-08-11
• Results First Submitted QC: 2011-12-01
• Results First Posted: 2012-01-13
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-29
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

Inclusion Criteria

• Male or female subjects 18 years of age with type 1 or type 2 diabetes.
• Subjects with peripheral occlusive arterial disease (PAOD) and a neuropathy disability score (NDS) of >3

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Exclusion Criteria

• Subjects who have undergone vascular reconstruction or angioplasty less than 1 month prior to randomization. Subjects with an ulcer grading of 0 or 3 and staging of A, B or D according to the University of Texas wound classification system.
• Subjects with a known bleeding disorder or evidence of active bleeding.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo for Fragmin/ Dalteparin Sodium	Placebo
Active	Fragmin/ Dalteparin Sodium	Active study treatment

Primary Outcome Measures

Name	Time	Method
Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Including Intact Skin Healing	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Underwent Any Amputation	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 With Intact Skin Healing	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 Major and Minor Amputation	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 Major Cardiovascular Disease Events (MCVE)	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.
Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)	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.
Number of Participants With Greater Than or Equal to 50 Percent Reduction in Ulcer Surface Area Excluding Intact Skin Healing	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	Week 24 (EOT) or early termination
11-point Likert Pain Scale	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.
Median Time to First Amputation	Week 24 (EOT) or early termination
Time to Intact Skin Healing	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.
Euro Quality of Life-5 Dimensions (EQ-5D)- Utility Score	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.
36-Item Short-Form Health Survey (SF-36) Score	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).
Transcutaneous Local Tissue Oxygenation (pO2)	Baseline and Week 24 (EOT or early termination)	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Peterborough, United Kingdom