N/A N=4,549

Longitudinal Study of Weight Change Following Lower Limb Amputation

Amputation Wound · Traumatic Amputation of Toe · Dysvascular Amputation of Lower Limb

Bottom Line

View on ClinicalTrials.gov: NCT00932399 ↗

Enrolled (actual)

4,549

Serious AEs

—

Results posted

Oct 2014

Primary outcome: Primary: % Weight Change From Baseline — 5.5; 0.9 % weight change

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 27+ yrs
Sex: Male
Sponsor: VA Office of Research and Development
Primary completion: Aug 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY % Weight Change From Baseline	5.5; 0.9	—

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.

Eligibility Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00932399). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.