SBIR-STTR Award

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. PROPOSED COMMERCIAL APPLICATIONS: 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.

Insurance providers spend millions of dollars on prosthetics and pressure reducing modalities for diabetes-related wound care; however, no scientific data exists on shear (friction) and scarce data on pressure reduction. Presently, no commercially available removable cast walker reduces shear. Salix Medical's (patent pending) removable cast walker (ACE walker) uses a unique shear modulation technology to eliminate peaks in pressure and shear at the sole of the foot. Such peaks usually initiate or exacerbate a destructive pathway that involves ulceration and may well lead to amputation in patients with diabetes. This randomized clinical trial will evaluate the 1) ACE walker versus 2) the clinical 'gold standard" Total Contact Casts and 3) standard Healing Sandals to heal diabetic foot ulcers. In addition the study will evaluate functional status and health care costs among treatment groups. Three groups of thirty-five diabetics with neuropathic ulcerations will be selected to participate in a 12-week clinical trial. At baseline, and at two week intervals, clinical evaluations will be performed to assess wound size and depth.

Thesaurus Terms:
assistive device /technology, biomedical equipment development, decubitus ulcer, diabetes mellitus, evaluation /testing, foot, medical complication, orthotics biomechanics, clinical trial phase II /III /IV, diabetic neuropathy, gait, mechanical stress, orthopedics, wound healing clinical research, human subject, patient oriented research