IceExplore TF Liner Alpha Investigation

Brief Summary

Single group prospective repeated measures comparing breathable liner and breathable socket to conventional enclosed silicone liner and socket system. IceExploreTF liner, the investigational device, is intended to function as part of a system that replaces a missing limb, a prosthetic interface with suction suspension technology and force transmission properties. More specifically, it is intended to reduce the skin humidity associated with the closed environment of predicate liners whilst maintaining secure suspension and user comfort. The literature indicates that the impact of sweat and heat on quality of life for trans-femoral amputees is significant and actions to improve sweat and heat issues with the prosthesis can contribute substantially to the well-being of amputees and could additionally have a positive effect on residual limb skin health.