Amputation WoundNCT00932399
Longitudinal Study of Weight Change Following Lower Limb Amputation
An observational study of Amputation Wound and Traumatic Amputation of Toe, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 27 to 89 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Amputation Wound, Traumatic Amputation of Toe, Dysvascular Amputation of Lower Limb
- How many people
- 4,549 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jan 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 27 to 89 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Veterans who received care at a VISN20 medical facility between 1997 and 2008
Who may be able to join
- "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
Show all 9Show fewer
- 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"
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108
About this study
Official title: Weight Change, Physical Activity and Health Promotion in Veteran Amputees
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Weight Change From Baseline
Time window for 3 years is 31-39 months after baseline
Measured: At ~3 years after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startMar 2010
- Primary completionAug 2010
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amputation WoundStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,549 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Alyson J. Littman, PhD MPH, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932399
- Sponsor's protocol ID
- F6982-W
- Status last verified
- Jan 2016
- First submitted
- 1 Jul 2009
- Last updated
- 8 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 26453769
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Change, Physical Activity and Health Promotion in Veteran Amputees
- ClinicalTrials.gov ID
- NCT00932399
- Acronym / sponsor ID
- F6982-W
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,549 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Mar 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 3 Jul 2009 (estimated)
- Results
- Posted 7 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 27 to 89 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans who received care at a VISN20 medical facility between 1997 and 2008
Key inclusion criteria (9 listed)
- 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)
- no lower limb amputation during the study period
- no prior history of amputation
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
% Weight Change From Baseline
Time frame: At ~3 years after baseline
Time window for 3 years is 31-39 months after baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26453769Bouldin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alyson J. Littman, PhD MPH principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation Wound and Traumatic Amputation of Toe, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% Weight Change From Baseline (time frame: At ~3 years after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00932399, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016.