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Longitudinal Study of Weight Change Following Lower Limb Amputation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00932399
First received: July 1, 2009
Last updated: January 13, 2016
Last verified: January 2016
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
Overall Participants Analyzed 
[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


Publications of Results:

Responsible Party: VA Office of Research and Development
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: January 13, 2016
Health Authority: United States: Federal Government