Trial Outcomes & Findings for Longitudinal Study of Weight Change Following Lower Limb Amputation (NCT NCT00932399)
NCT ID: NCT00932399
Last Updated: 2016-02-08
Results Overview
Time window for 3 years is 31-39 months after baseline
Recruitment status
COMPLETED
Target enrollment
4549 participants
Primary outcome timeframe
At ~3 years after baseline
Results posted on
2016-02-08
Participant Flow
Participant milestones
| Measure |
Group 1
Underwent a procedure at a VA medical facility in Veterans Integrated Service Network #20 for a lower limb amputation between 1997 and 2008
|
Group 2
No history of lower limb amputation
|
|---|---|---|
|
Overall Study
STARTED
|
759
|
3790
|
|
Overall Study
COMPLETED
|
759
|
3790
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Longitudinal Study of Weight Change Following Lower Limb Amputation
Baseline characteristics by cohort
| Measure |
Group 1
n=759 Participants
Underwent a procedure at a VA medical facility in VISN 20 for a lower limb amputation between 1997 and 2008
|
Group 2
n=3790 Participants
No history of lower limb amputation
|
Total
n=4549 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<55 years
|
141 participants
n=39 Participants
|
705 participants
n=41 Participants
|
846 participants
n=35 Participants
|
|
Age, Customized
55-64 years
|
294 participants
n=39 Participants
|
1470 participants
n=41 Participants
|
1764 participants
n=35 Participants
|
|
Age, Customized
65-74 years
|
200 participants
n=39 Participants
|
995 participants
n=41 Participants
|
1195 participants
n=35 Participants
|
|
Age, Customized
75-89 years
|
124 participants
n=39 Participants
|
620 participants
n=41 Participants
|
744 participants
n=35 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
759 Participants
n=39 Participants
|
3790 Participants
n=41 Participants
|
4549 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: At ~3 years after baselineTime window for 3 years is 31-39 months after baseline
Outcome measures
| Measure |
Group 1
n=759 Participants
Underwent a procedure at a VA medical facility in VISN 20 for a lower limb amputation between 1997 and 2008
|
Group 2
n=3790 Participants
No history of lower limb amputation
|
|---|---|---|
|
% Weight Change From Baseline
|
5.5 % weight change
Interval 4.1 to 6.9
|
0.9 % weight change
Interval 0.0 to 1.8
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Alyson Littman
Seattle Epidemiologic Research and Information Center
Phone: 206-277-4182
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place