Status:
COMPLETED
Vacuum Suspension: Effects on Tissue Oxygenation, Activity and Fit
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Amputation
Diabetes
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The fit of the residual limb within a prosthetic socket is a primary concern for many amputees. A poor fit can lead to skin irritation, tissue breakdown, and pain. Further, amputees with diabetes or v...
Detailed Description
A proper fitting prosthetic socket provides the amputee with a comfortable system allowing them to pursue many of their desired vocational and recreational goals. Unfortunately, many amputees live wit...
Eligibility Criteria
Inclusion
- Over 18 and less than 70 years of age,
- Have a below knee amputation involving only one side,
- If the cause of amputation was for traumatic reasons and do not have diabetes or a vascular condition, the amputation must have occurred at least six months ago and the potential subject must have worn a prosthesis for at least four months,
- If the cause of amputation was for diabetes or vascular reasons, the potential subject must have been fit with a prosthesis and have worn it for at least one year,
- Wear the prosthesis for at least 6 hours a day,
- Able to walk without a cane, crutches, or a walker,
- Are moderately active enough to walk at a steady pace for at least 30 minutes.
Exclusion
- Have pain in legs or any condition that interferes with walking.
- Have an ulcer on the residual limb,
- If potential subject had an amputation because of a tumor or an infection, no longer have an active tumor or undergoing treatment for a tumor,
- Have fallen within the last 3 months.
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00117793
Start Date
August 1 2005
End Date
September 1 2008
Last Update
August 15 2014
Active Locations (1)
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1
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108