Longitudinal Study of Weight Change Following Lower Limb Amputation

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

4549 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Impact of Lower Limb Fractures on Body Mass Index (BMI)

NCT05162521

Fracture

UNKNOWN

Metabolic and Neural Adaptations to Weight Loss, Plateau, and Regain

NCT02199483

Healthy Volunteers

WITHDRAWN

Effect of Weight Loss on Body Composition and Metabolic Function in Women With Lipedema

NCT03271034

Lipedema Metabolism

COMPLETED NA

Aging, Exercise, and Hormonal Influences of Fat Metabolism

NCT00100451

Cardiovascular Disease

COMPLETED NA

Energy Metabolism and Nutrient Absorption in Lean and Obese Individuals

NCT00414063

Obesity

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Amputation Wound Traumatic Amputation of Toe Dysvascular Amputation of Lower Limb

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

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

No interventions assigned to this group

Group 2

No history of lower limb amputation

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

27 Years

Maximum Eligible Age

89 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes