Longitudinal Study of Weight Change Following Lower Limb Amputation

NCT00932399 | Completed Results

• 1 other identifier: F6982-W
• Study Type: observational
• Target: 4,549
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• % Weight Change From Baseline

  Time window for 3 years is 31-39 months after baseline

  At ~3 years after baseline

Study Arms (2)

Group 1

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

Group 2

No history of lower limb amputation

Eligibility Criteria

• Age: 27 Years - 89 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Veterans who received care at a VISN20 medical facility between 1997 and 2008

You may qualify if:

• "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"

You may not qualify if:

• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

Related Publications (1)

• Bouldin ED, Thompson ML, Boyko EJ, Morgenroth DC, Littman AJ. Weight Change Trajectories After Incident Lower-Limb Amputation. Arch Phys Med Rehabil. 2016 Jan;97(1):1-7.e1. doi: 10.1016/j.apmr.2015.09.017. Epub 2015 Oct 8.

  PMID: 26453769 RESULT

Results Point of Contact

• Title: Alyson Littman
• Organization: Seattle Epidemiologic Research and Information Center

alyson.littman@va.gov

206-277-4182

Study Officials

• Alyson J. Littman, PhD MPH

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2009
• First Posted: July 3, 2009
• Study Start: March 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: January 1, 2016
• Last Updated: February 8, 2016
• Results First Posted: October 7, 2014

Record last verified: 2016-01

Locations

US (1)