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Completed

NCT Number: NCT00932399

Longitudinal Study of Weight Change Following Lower Limb Amputation

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.

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Key information

Conditions

Amputation Wound Dysvascular Amputation of Lower Limb Traumatic Amputation of Toe

Age range

27 year–89 year

Sex eligibility

Male

Study type

Observational

Primary location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. % Weight Change From Baseline

    Time frame: At ~3 years after baseline

    Time window for 3 years is 31-39 months after baseline

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Weight Change, Physical Activity and Health Promotion in Veteran Amputees

Important dates

Study start
2010
Primary completion
2010
Study completion
2016
First posted
Jul 3, 2009
Registry last updated
Feb 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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