N/A
Completed N=4,549
Longitudinal Study of Weight Change Following Lower Limb Amputation
Amputation Wound · Traumatic Amputation of Toe · Dysvascular Amputation of Lower Limb
Source: ClinicalTrials.gov NCT00932399 ↗
Enrolled (actual)
4,549
Serious AEs
—
Results posted
Oct 2014
Primary outcomePrimary: % Weight Change From Baseline — 5.5; 0.9 % weight change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY % Weight Change From Baseline |
5.5; 0.9 | — |
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)
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. Informational only — not medical advice.