Longitudinal Study of Weight Change Following Lower Limb Amputation

Completed

• Conditions: Amputation Wound; Traumatic Amputation of Toe; Dysvascular Amputation of Lower Limb

• Registration Number: NCT00932399
• Lead Sponsor: VA Office of Research and Development

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-01
• Study First Submitted QC: 2009-07-01
• Study First Posted: 2009-07-03
• Study Start: 2010-03
• Primary Completion: 2010-08
• Results First Submitted: 2014-10-02
• Results First Submitted QC: 2014-10-06
• Results First Posted: 2014-10-07
• Status Verified: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-13
• Last Update Posted: 2016-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 4549

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
% Weight Change From Baseline	At ~3 years after baseline	Time window for 3 years is 31-39 months after baseline

Trial Locations

Locations (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA; 🇺🇸 Seattle, Washington, United States