Longitudinal Study of Weight Change Following Lower Limb Amputation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00932399
First received: July 1, 2009
Last updated: October 6, 2014
Last verified: October 2014
Results First Received: October 2, 2014  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Retrospective
Conditions: Amputation Wound
Traumatic Amputation of Toe
Dysvascular Amputation of Lower Limb

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Group 1 Underwent a procedure at a VA medical facility in Veterans Integrated Service Network #20 for a lower limb amputation between 1997 and 2008
Group 2 No history of lower limb amputation

Participant Flow:   Overall Study
    Group 1     Group 2  
STARTED     759     3790  
COMPLETED     759     3790  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Group 1 Underwent a procedure at a VA medical facility in VISN 20 for a lower limb amputation between 1997 and 2008
Group 2 No history of lower limb amputation
Total Total of all reporting groups

Baseline Measures
    Group 1     Group 2     Total  
Number of Participants  
[units: participants]
  759     3790     4549  
Age, Customized  
[units: participants]
     
<55 years     141     705     846  
55-64 years     294     1470     1764  
65-74 years     200     995     1195  
75-89 years     124     620     744  
Gender  
[units: participants]
     
Female     0     0     0  
Male     759     3790     4549  



  Outcome Measures

1.  Primary:   % Weight Change From Baseline   [ Time Frame: At ~3 years after baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Alyson Littman
Organization: Seattle Epidemiologic Research and Information Center
phone: 206-277-4182
e-mail: alyson.littman@va.gov


No publications provided


Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00932399     History of Changes
Other Study ID Numbers: F6982-W
Study First Received: July 1, 2009
Results First Received: October 2, 2014
Last Updated: October 6, 2014
Health Authority: United States: Federal Government