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Longitudinal Study of Weight Change Following Lower Limb Amputation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00932399
First Posted: July 3, 2009
Last Update Posted: February 8, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
The purpose of this study is to assess weight change in a population of Veterans with amputations. Little is known about the how weight changes following an amputation. It is widely believed that many patients experience weight gain following amputation. This study aims to identify magnitude of weight changes following amputation and determine characteristics associated with weight gain. Information on weight change trajectories would be useful to better understand long-term health consequences associated with amputation and to design and target interventions to encourage weight maintenance and general health promotion for groups at high risk of weight gain.

Condition
Amputation Wound Traumatic Amputation of Toe Dysvascular Amputation of Lower Limb

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Weight Change, Physical Activity and Health Promotion in Veteran Amputees

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • % Weight Change From Baseline [ Time Frame: At ~3 years after baseline ]
    Time window for 3 years is 31-39 months after baseline


Enrollment: 4549
Study Start Date: March 2010
Study Completion Date: January 2016
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   27 Years to 89 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Veterans who received care at a VISN20 medical facility between 1997 and 2008
Criteria

Inclusion Criteria:

"Exposed" cohort:

  • incident lower limb amputation during the study period (1/1997-12/2008) in VISN 20
  • >= 1 plausible weight recoded in the medical record at baseline (defined as 8 weeks before amputation or 2-8 weeks post amputation)
  • >=1 weight measured post amputation (2 months to 42 months post amputation)

"Unexposed" (comparison) cohort:

  • no lower limb amputation during the study period
  • no prior history of amputation
  • >= 2 plausible recorded weights including at least one in the 2-6 weeks after their reference date ("baseline").
  • Alive at least 18 months after "baseline"

Exclusion Criteria:

  • female (due to small number of women with lower limb amputations)
  • lack information on any of the characteristics used for matching (e.g., birth year/age and height to calculate body mass index)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00932399


Locations
United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Alyson J. Littman, PhD MPH VA Puget Sound Health Care System Seattle Division, Seattle, WA
  More Information

Publications:
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00932399     History of Changes
Other Study ID Numbers: F6982-W
First Submitted: July 1, 2009
First Posted: July 3, 2009
Results First Submitted: October 2, 2014
Results First Posted: October 7, 2014
Last Update Posted: February 8, 2016
Last Verified: January 2016

Additional relevant MeSH terms:
Body Weight Changes
Amputation, Traumatic
Body Weight
Signs and Symptoms
Wounds and Injuries