Status:
COMPLETED
Longitudinal Study of Weight Change Following Lower Limb Amputation
Lead Sponsor:
VA Office of Research and Development
Conditions:
Amputation Wound
Traumatic Amputation of Toe
Eligibility:
MALE
27-89 years
Brief Summary
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...
Eligibility Criteria
Inclusion
- "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
- 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)
Key Trial Info
Start Date :
March 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
4549 Patients enrolled
Trial Details
Trial ID
NCT00932399
Start Date
March 1 2010
End Date
January 1 2016
Last Update
February 8 2016
Active Locations (1)
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1
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108