Lower Limb Amputation Clinical Trial
Official title:
Prosthetic Socket System: Pilot Assessment
The purpose of the study is to evaluate residual limb circulation and skin health associated with the use of a prosthetic vacuum socket. A conventional non-vacuum prosthetic socket will be compared to a vacuum prosthetic socket.
The prosthetic suspension plays a pivotal role in an amputee's comfort. It can also
significantly impact an amputee's limb health. If the prosthesis is not held securely to the
amputee's limb, relative movement between the limb and prosthetic interface can cause
bruising, skin irritation and skin breakdown. These poor outcomes are uncomfortable and can
lead to much more serious health conditions. A positive solution to creating secure and
comfortable suspension is the use of a vacuum suspension socket. The vacuum pressure assists
in preventing movement in the socket. The clinical benefits associated with vacuum
suspension include volume retention, increased proprioception, secure suspension, and
frequently reported observations of wound healing. However, the long term effects of vacuum
suspension on circulation remain undetermined or undocumented.
This study examines a vacuum suspension system on the health of the residual limb (amputated
limb). A vacuum socket creates a vacuum between the rigid prosthetic socket and prosthetic
liner which is sealed to the socket. Therefore, vacuum is not directly applied to the skin
of the residual limb.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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