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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
History of Changes
Results First Received: August 11, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetic Foot Ulcer
Intervention: Drug: Fragmin

  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
This was a follow-up study of A6301083 (NCT00662831)

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 sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.

Participant Flow:   Overall Study
    Dalteparin  
STARTED     62  
COMPLETED     30  
NOT COMPLETED     32  
Lack of Efficacy                 5  
Withdrawal by Subject                 1  
Unspecified                 16  
Protocol Violation                 6  
Adverse Event                 4  



  Baseline Characteristics
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Reporting Groups
  Description
Dalteparin Dalteparin sodium 5000 International Units (IU) (0.2 mL) administered subcutaneously (s.c.) once daily (OD) for a maximum duration of 24 weeks.

Baseline Measures
    Dalteparin  
Number of Participants  
[units: participants]
 		  62  
Age  
[units: years]
Mean ± Standard Deviation 		  65.2  ± 11.0  
Gender  
[units: participants]
 		 
Female     16  
Male     46  



  Outcome Measures
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1.  Primary:   Number of All Hemorrhages   [ Time Frame: Baseline to Week 24 (end of treatment [EOT]) or early termination (ET) ]
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2.  Primary:   Number of Major Hemorrhages   [ Time Frame: Baseline to Week 24 (EOT) or ET ]
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3.  Primary:   Number of Minor Hemorrhages   [ Time Frame: Baseline to Week 24 (EOT) or ET ]
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4.  Primary:   Number of Clinically Relevant Minor Hemorrhages   [ Time Frame: Baseline to Week 24 (EOT) or ET ]
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5.  Primary:   Number of Trivial Hemorrhages   [ Time Frame: Baseline to Week 24 (EOT) or ET ]
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6.  Secondary:   Number of Participants With Intact Skin Healing   [ Time Frame: Baseline through Week 24 (EOT) or ET ]
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7.  Secondary:   Number of Participants With Improved Ulcer Healing   [ Time Frame: Baseline through Week 24 (EOT) or ET ]
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8.  Secondary:   Number of Participants Who Underwent Amputation   [ Time Frame: Baseline through Week 24 (EOT) or ET ]
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9.  Secondary:   Time to Intact Skin Healing   [ Time Frame: Baseline through Week 24 (EOT) or ET ]
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10.  Secondary:   Time to First Amputation   [ Time Frame: Baseline through Week 24 (EOT) or ET ]
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11.  Secondary:   Number of Participants With Major Cardiovascular Disease Events (MCVE)   [ Time Frame: Baseline through Week 24 (EOT) or ET ]
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12.  Secondary:   11-point Likert Pain Scale   [ Time Frame: Baseline and Week 24 (EOT) or ET ]
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13.  Secondary:   36-Item Short-Form Health Survey (SF-36) Score   [ Time Frame: Baseline and Week 24 (EOT) or ET ]
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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: 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