Status:
COMPLETED
Study to Determine if Different Prosthetic Sockets Effect How Much Oxygen is in the Tissue of Lower Limb Amputees While They Are Walking
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
University of Washington
Conditions:
Amputation
Diabetes Complications
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Amputee gait produces periodic occlusion of residual limb blood vessels. During the stance phase of gait, body weight cause the prosthesis to compresses the soft tissue of the residual limb and occlud...
Detailed Description
The amount of oxygen in residual limb tissue is an important health status indicator; resistance to infection, promotion of wound healing, production of collagen, and epithelialization all correlate w...
Eligibility Criteria
Inclusion
- All subjects must meet the following inclusion criteria:
- unilateral transtibial amputee of diabetic etiology between the ages of 18 and 70,
- have been fit with a prosthesis and have used a prosthesis for at least one year,
- wear the prosthesis at least 4 hours per day,
- ambulate without upper extremity aids, and
- have no history of injurious falls within the previous six months.
Exclusion
- Subjects will be excluded if:
- they have a significant lower extremity pain condition, musculoskeletal disorder, or neurological deficit that interferes with their ability to pursue typical daily activities or alters their gait characteristics or
- their residual limb is ulcerated.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2012
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00985842
Start Date
November 1 2009
End Date
October 26 2012
Last Update
June 29 2018
Active Locations (1)
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1
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108