Amputation Wound, Dysvascular Amputation of Lower Limb, Traumatic Amputation of Toe
Conditions
Brief 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.
Interventions
None listed
Sponsors
VA Office of Research and Development
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
27 Years to 89 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % Weight Change From Baseline | At ~3 years after baseline | Time window for 3 years is 31-39 months after baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Underwent a procedure at a VA medical facility in VISN 20 for a lower limb amputation between 1997 and 2008 | 759 |
| Group 2 No history of lower limb amputation | 3,790 |
| Total | 4,549 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Total |
|---|---|---|---|
| Age, Customized 55-64 years | 294 participants | 1470 participants | 1764 participants |
| Age, Customized <55 years | 141 participants | 705 participants | 846 participants |
| Age, Customized 65-74 years | 200 participants | 995 participants | 1195 participants |
| Age, Customized 75-89 years | 124 participants | 620 participants | 744 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 759 Participants | 3790 Participants | 4549 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
% Weight Change From Baseline
Time window for 3 years is 31-39 months after baseline
Time frame: At ~3 years after baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Group 1 | % Weight Change From Baseline | 5.5 % weight change |
| Group 2 | % Weight Change From Baseline | 0.9 % weight change |