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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
10
Conventional prosthetic socket utilizing non-vacuum suspension to secure the residual limb to the prosthesis. Non-vacuum suspension includes pin/lock suspension and suction suspension.
Prosthetic socket that incorporates conventional vacuum suspension using the commercially available LimbLogic vacuum pump
The Ohio State University Davis Heart and Lung Research Institute
Columbus, Ohio, United States
RECRUITINGThe Ohio Willow Wood Company
Mount Sterling, Ohio, United States
RECRUITINGTranscutaneous partial pressure of oxygen (tcpO2 level) at 16 wks
Change from baseline in Transcutaneous partial pressure of oxygen (tcpO2 level) at 16 wks
Time frame: 16 weeks
Transcutaneous partial pressure of oxygen (tcpO2 level) at 8 wks
Change from baseline in Transcutaneous partial pressure of oxygen (tcpO2 level) at 8 wks
Time frame: 8 weeks
Hyperspectral Imaging Tissue Oxygen Saturation (StO2%) at 8wks
Change from baseline in Hyperspectral Imaging StO2% at 8wks
Time frame: 8 weeks
Hyperspectral Imaging StO2% at 16wks
change from baseline in Hyperspectral Imaging StO2% at 16wks
Time frame: 16 weeks
Laser speckle flowmetry tissue perfusion values at 8wks
Change from baseline in Laser speckle flowmetry tissue perfusion values at 8wks
Time frame: 8 weeks
Laser speckle flowmetry tissue perfusion values at 16wks
Change from baseline in Laser speckle flowmetry tissue perfusion values at 16wks
Time frame: 16 weeks
Laser Doppler flowmetry tissue perfusion values at 8wks
Change from baseline in Laser Doppler flowmetry tissue perfusion values at 8wks
Time frame: 8 weeks
Laser Doppler flowmetry tissue perfusion values at 16wks
Change from baseline in Laser Doppler flowmetry tissue perfusion values at 16wks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 16 weeks