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Reduction in Foot Ulcer Treatment Costs Using Pressure-based In-Shoe Orthoses
JAN S. ULBRECHT, TIMOTHY HURLEY, PETER R. CAVANAGH
Presented at the 74th American Diabetes Association Mtg; San Francisco; June 14-17 2014
The purpose of this study was to estimate the potential annual treatment cost savings for diabetic foot ulcers (DFUs) in the U.S. associated with use of orthoses that are custom-designed based on measured barefoot plantar pressure versus current standard of care.
DFU occurrence rates from a recently concluded single-blinded multi-center randomized controlled trial (CareFUL Prevention) were used to model the potential impact on DFU treatment costs. In the CareFUL Prevention trial occurrence of DFUs in high-risk patients with a history of forefoot plantar neuropathic ulcers were compared between groups randomized to wear orthoses custom designed based on measured barefoot plantar pressure (P) or standard of care HCPCS code A5513 inserts that are custom molded to the foot with optional modification based on clinical criteria (S). P have been previously shown to off-load the forefoot significantly better than S. The hazard ratio for the occurrence of an ulcer in S compared to P in this study was 3.4 (95%CI 1.3-8.7). Prevalence of diabetic neuropathy, forefoot DFU’s and associated treatment costs were estimated from published studies and used to model annual DFU treatment costs in the U.S. based on the use of P versus S. Costs were projected to 2013 U.S. dollars.
Applying outcomes from the CareFUL Prevention trial, potential gross DFU treatment cost savings in the U.S. was $4.5 billion annually. A sensitivity analysis estimated the range of annual cost savings to be between $1.5 and $8.7 billion. On a net cost basis (factoring the additional cost of design and fabrication of P orthoses compared to C inserts), the estimated DFU treatment cost savings per 100 high-risk patients was $375,000 annually.
Use of orthoses custom-designed based on measured barefoot plantar pressure, that both off-load and prevent forefoot DFUs better than standard of care A5513 inserts, have the potential to result in significant prevention of DFUs and therefore substantial treatment costs savings.
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