Study to Determine if Different Prosthetic Sockets Effect How Much Oxygen is in the Tissue of Lower Limb Amputees While They Are Walking
Completed · Not applicable
Conditions studied: Amputation, Diabetes Complications, Leg Injuries, Traumatic Amputation
In brief
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 occlude blood flow. This occlusion can be relieved during swing phase, but may depend on type of prosthesis. The purpose of the proposed research is to: (1) discover the range of tissue oxygenation in the intact and residual lower limbs of dysvascular amputees during gait and (2) to learn which of five different prosthetic limb systems provides greater tissue oxygenation.
Key facts
- Study ID
- NCT00985842
- Run by
- VA Office of Research and Development
- People needed
- 7
- Starts
- 2009-11-01
- Expected to finish
- 2012-10-26
- Last updated by the study team
- 2018-06-29
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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