Vacuum Suspension: Effects on Tissue Oxygenation, Activity and Fit

Completed · Not applicable

Conditions studied: Amputation, Diabetes, Leg Injuries, Traumatic Amputations

In brief

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 vascular dysfunction often have difficulty maintaining healthy residual limb tissue; a condition that could be mitigated by the application of negative pressure (i.e., vacuum suspension). The aim of this research is to characterize the residual limb response to a vacuum suspension system and to measure prosthetic performance in comparison to a typical suction suspension system. The proposed research plan involves two sets of human subject experiments: (1) prospective, randomized cross-over study to quantify performance of a vacuum suspension system as compared to a total surface bearing suction socket in terms of pistoning, maintaining limb volume, step counts, and subjective measures of fit and (2) measurement of transcutaneous oxygen tension as a function of vacuum pressure.

Key facts

Study ID

NCT00117793

Run by

US Department of Veterans Affairs

People needed

20

Starts

2005-08-01

Expected to finish

2008-09-01

Last updated by the study team

2014-08-15

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• VA Puget Sound Health Care System, Seattle — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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