Presently, no commercially available removable cast walker's design reduces shear. Salix Medical's removable cast walker (ACE walker) uses pressure reduction and a unique shear modulation technology (patent pending) to eliminate peaks in pressure and shear at the sole of the foot, which usually initiate or exacerbate a destructive pathway that involves ulceration and amputation in patients with diabetes. Although insurance providers spend millions of dollars on prosthet6ics and pressure reducing modalities for diabetes-related wound care, no scientific data exists on shear and scarce data on pressure reduction. This study will evaluate the ACE walker and a commercially available, and widely used, removable pneumatic cast walker. The two systems are identical in functionality, except that the ACE walker incorporates shear and pressure reduction technology at the interface between the foot's plantar aspect and the walker's insole. Two groups of ten subject per group with a history of diabetes-related neuropathic ulceration in a 16-week trial will be selected. Subjects will be randomized into the ACE group and control walker group. At baseline, and every four weeks, in vivo gait pressure measurements will be performed, along with in vitro mechanical testing, which will measure changes in the stiffness and shear behavior of the walkers.
As many as 18 million persons in the U.S. suffer from diabetes. Of this population some 20% (3 million plus) are categorized as being at high- risk for amputation due to severe infections affecting the bottom of the foot. Shear is the most salient etiological component in the development of wounds in most patients with diabetes. Salix Medical's ACE walker is a system that should prove extremely useful, if not the gold standard, for those diabetic patients requiring removable walkers.
