Overview

This trial is active, not recruiting.

Conditions amputation wound, traumatic amputation of toe, dysvascular amputation of lower limb
Sponsor Department of Veterans Affairs
Start date March 2010
End date August 2010
Trial size 4549 participants
Trial identifier NCT00932399, F6982-W

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Underwent a procedure at a VA medical facility in VISN 20 for a lower limb amputation between 1997 and 2008
No history of lower limb amputation

Primary Outcomes

Measure
% Weight Change From Baseline
time frame: At ~3 years after baseline

Eligibility Criteria

Male participants from 27 years up to 89 years old.

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)

Additional Information

Official title Weight Change, Physical Activity and Health Promotion in Veteran Amputees
Principal investigator Alyson J. Littman, PhD MPH
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Department of Veterans Affairs.