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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00662831
First received: April 16, 2008
Last updated: December 1, 2011
Last verified: December 2011
History of Changes
Results First Received: August 11, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Diabetic Foot Ulcer
Interventions: Drug: Fragmin/ Dalteparin Sodium
Drug: Placebo for Fragmin/ Dalteparin Sodium

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Dalteparin Dalteparin 5000 International Units (IU) (0.2 milliliter [mL]) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
Placebo Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.

Participant Flow:   Overall Study
    Dalteparin     Placebo  
STARTED     184     92  
COMPLETED     78     33  
NOT COMPLETED     106     59  
Death                 4                 1  
Lack of Efficacy                 6                 6  
Lost to Follow-up                 1                 0  
Withdrawal by Subject                 2                 1  
Unspecified                 62                 31  
Protocol Violation                 8                 4  
Adverse Event                 23                 16  



  Baseline Characteristics
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Reporting Groups
  Description
Dalteparin Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
Placebo Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.
Total Total of all reporting groups

Baseline Measures
    Dalteparin     Placebo     Total  
Number of Participants  
[units: participants]
 		  184     92     276  
Age  
[units: years]
Mean ± Standard Deviation 		  64.8  ± 10.3     64.7  ± 10.9     64.8  ± 10.5  
Gender  
[units: participants]
 		     
Female     63     30     93  
Male     121     62     183  



  Outcome Measures
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1.  Primary:   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 ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants With Intact Skin Healing   [ Time Frame: Week 24 (EOT) or early termination ]
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3.  Secondary:   Number of Participants Who Underwent Any Amputation   [ Time Frame: Week 24 (EOT) or early termination ]
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4.  Secondary:   Number of Participants Who Underwent Major and Minor Amputation   [ Time Frame: Week 24 (EOT) or early termination ]
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5.  Secondary:   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 ]
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6.  Secondary:   Number of Participants Who Died   [ Time Frame: Week 24 (EOT) or early termination ]
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7.  Secondary:   Number of Participants With Major Cardiovascular Disease Events (MCVE)   [ Time Frame: Week 24 (EOT) or early termination ]
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8.  Secondary:   Time to Intact Skin Healing   [ Time Frame: Week 24 (EOT) or early termination ]
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9.  Secondary:   Median Time to First Amputation   [ Time Frame: Week 24 (EOT) or early termination ]
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10.  Secondary:   Euro Quality of Life-5 Dimensions (EQ-5D)- Utility Score   [ Time Frame: Baseline and Week 24 (EOT or early termination) ]
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11.  Secondary:   Euro Quality of Life (EQ-5D)- Visual Analog Scale (VAS)   [ Time Frame: Baseline and Week 24 (EOT or early termination) ]
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12.  Secondary:   36-Item Short-Form Health Survey (SF-36) Score   [ Time Frame: Baseline and Week 24 (EOT or early termination) ]
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13.  Secondary:   11-point Likert Pain Scale   [ Time Frame: Baseline and Week 24 (EOT or early termination) ]
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Measure Type Secondary
Measure Title 11-point Likert Pain Scale
Measure Description 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)  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population included all participants who were randomized. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each group respectively.

Reporting Groups
  Description
Dalteparin Dalteparin 5000 International Units (IU) (0.2 mL) subcutaneously (s.c.) once daily for 24 weeks or early termination (ET).
Placebo Placebo (0.2 mL normal saline) administered s.c. once daily for 24 weeks or ET.

Measured Values
    Dalteparin     Placebo  
Number of Participants Analyzed  
[units: participants]
 		  183     89  
11-point Likert Pain Scale  
[units: Units on a scale]
Mean ± Standard Deviation 		   
Baseline     4.20  ± 2.76     4.50  ± 2.83  
EOT (n= 155, 75)     2.10  ± 2.27     2.50  ± 2.54  

No statistical analysis provided for 11-point Likert Pain Scale



14.  Secondary:   Transcutaneous Local Tissue Oxygenation (pO2)   [ Time Frame: Baseline and Week 24 (EOT or early termination) ]
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15.  Other Pre-specified:   Number of All Hemorrhages   [ Time Frame: Week 24 (EOT) or early termination ]
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16.  Other Pre-specified:   Number of Major and Minor Hemorrhages   [ Time Frame: Week 24 (EOT) or early termination ]
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17.  Other Pre-specified:   Number of Clinically Relevant Minor Hemorrhages and Trivial Hemorrhages   [ Time Frame: Week 24 (EOT) or early termination ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study enrollment was terminated before planned number of participants was obtained. Although randomized participants were allowed to complete entire course of therapy according to protocol and study status was therefore designated as completed.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00662831     History of Changes
Other Study ID Numbers: A6301083
Study First Received: April 16, 2008
Results First Received: August 11, 2011
Last Updated: December 1, 2011
Health Authority: United Kingdom: Research Ethics Committee