Longitudinal Study of Weight Change Following Lower Limb Amputation

VA Office of Research and Development

Status: Completed

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

Study type: Observational

Funder types: Other U.S. Federal agency

Identifiers

NCT00932399

F6982-W

Details and patient eligibility

About

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.

Enrollment: 4,549 patients

Sex: Male

Ages: 27 to 89 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

4,549 participants in 2 patient groups

Group 1

Description:

Underwent a procedure at a VA medical facility in VISN 20 for a lower limb amputation between 1997 and 2008

Group 2

Description:

No history of lower limb amputation