application) Foot ulcers in people with diabetes mellitus represent a major public health problem of increasing magnitude and escalating health care expenditure. Diabetic foot ulcers are frequently due to a combination of peripheral neuropathy, minor trauma, peripheral vascular disease and accompanying foot deformity which often lead directly to lower extremity amputation (LEA) Currently, total contact casting (TCC) is the most rapid and effective method for healing diabetic neuropathic foot ulcers. TCC has several major drawbacks including requiring specialized skills in the application, patient reports of difficulties with walking and ADL function and frequent cast changes to prevent complications. These limitations have prevented its wide-spread adoption as the optimal off-loading therapy. Recently, some removable ankle foot orthoses (AFOs) have been shown to reduce plantar pressures to a similar extent as TCC, though ulcer healing outcomes have not yet been demonstrated. Removable AFOs offer many potential advantages over TCC such as lower costs, easier patient application and greater convenience by requiring fewer visits to health care specialists. The overall goal of this application is to conduct a prospective, randomized controlled clinical trial comparing TCC to a removable AFO to determine the optimal off-loading therapy for healing diabetic, neuropathic foot ulcers.
The Specific Aims of this project are to determine the percent of subjects with Wagner grade 1 or 2 neuropathic foot ulcers who completely heal within 8 weeks; and the time (in days) it requires to achieve complete healing using each off-loading therapy. Additional aims will be to determine the impact each off-loading therapy has on subjects' level of impairment, functional limitation, disability and to determine the costs and cost-effectiveness associated with each offloading therapy based on discrete indicators of patient severity and compliance to each therapy. The results of this application will have an immediate impact toward increasing our current understanding of the magnitude of pressure offloading which is required to achieve successful healing outcomes. In addition, we will define the optimal off-loading therapy for rapid and effective ulcer healing outcomes which promise to reduce the annual number of LEAs, limit the burden of disability and demonstrate the most cost-effective pressure off-loading therapy in patients with diabetes mellitus and chronic foot ulcers.
| Tuttle, Lori J; Bittel, Daniel C; Bittel, Adam J et al. (2018) Early-Onset Physical Frailty in Adults With Diabesity and Peripheral Neuropathy. Can J Diabetes 42:478-483 |
| Sinacore, David R; Hastings, Mary K; Bohnert, Kathryn L et al. (2017) Immobilization-induced osteolysis and recovery in neuropathic foot impairments. Bone 105:237-244 |
| Gelber, Judith R; Sinacore, David R; Strube, Michael J et al. (2014) Windlass Mechanism in Individuals With Diabetes Mellitus, Peripheral Neuropathy, and Low Medial Longitudinal Arch Height. Foot Ankle Int 35:816-824 |
| Hastings, Mary K; Johnson, Jeffrey E; Strube, Michael J et al. (2013) Progression of foot deformity in Charcot neuropathic osteoarthropathy. J Bone Joint Surg Am 95:1206-13 |
| Hastings, Mary K; Sinacore, David R; Mercer-Bolton, Nicole et al. (2011) Precision of foot alignment measures in Charcot arthropathy. Foot Ankle Int 32:867-72 |
| Gutekunst, David J; Hastings, Mary K; Bohnert, Kathryn L et al. (2011) Removable cast walker boots yield greater forefoot off-loading than total contact casts. Clin Biomech (Bristol, Avon) 26:649-54 |
| Hastings, Mary K; Gelber, Judy R; Isaac, Elena J et al. (2010) Foot progression angle and medial loading in individuals with diabetes mellitus, peripheral neuropathy, and a foot ulcer. Gait Posture 32:237-41 |
| Sinacore, David R; Hastings, Mary K; Bohnert, Kathryn L et al. (2008) Inflammatory osteolysis in diabetic neuropathic (charcot) arthropathies of the foot. Phys Ther 88:1399-407 |
| Sinacore, David R; Bohnert, Kathryn L; Hastings, Mary K et al. (2008) Mid foot kinetics characterize structural polymorphism in diabetic foot disease. Clin Biomech (Bristol, Avon) 23:653-61 |
| Hastings, Mary Kent; Gelber, Judy; Commean, Paul K et al. (2008) Bone mineral density of the tarsals and metatarsals with reloading. Phys Ther 88:766-79 |
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