Offloading Device for the Reduction of Foot Complications in Diabetic Patients Michael Osborne Michael Osborne Rod Aliabadi Rod Aliabadi Patrick Gonzales Patrick Gonzales Colin Smith Colin Smith Supported by: Supported by: Dr. William Dougherty-Advisor Richard Brown-Certified Pedorthist Dr. Kevin Robinson-Belmont Univ. Gait Lab

Diabetes and the Effects Affects 20.8 million Americans Affects 20.8 million Americans Insufficient insulin production or action Insufficient insulin production or action Neuropathy Neuropathy Poor circulation Poor circulation Foot deformation Foot deformation Decreased healing Decreased healing

Deformations and Complications Charcot Foot Increased Pressure at Metatarsal Heads Foot Drop Hammer Toe

“Within the rapidly growing diabetes market, companies will find it extremely challenging to protect their market share because of intensifying competition, no longer can a manufacturer concentrate on just one segment and lead the market. Apart from having an ambitious product line strategy, manufacturers need to enter into other diabetes segments in order to not only protect but also grow their market share.” -Ajit Baid July 2003 CEO, F&S industry analysis

Is There a Legit Market? $27, million people 6% incidence = $34,927,776,000

Orthotic Insert Specifications Inexpensive-Minimize labor costs and cut costs of customized insert by at least 50% Inexpensive-Minimize labor costs and cut costs of customized insert by at least 50% Versatile-Manufacture it to fit any standard extra depth shoe; built in modifications Versatile-Manufacture it to fit any standard extra depth shoe; built in modifications Preventative-Minimize vertical plantar pressure and incidence of wounds in the TYPICAL neuropathic patient Preventative-Minimize vertical plantar pressure and incidence of wounds in the TYPICAL neuropathic patient Durability-Match the standard useful life of four months for custom inserts Durability-Match the standard useful life of four months for custom inserts

Current Technology Acor: QuickFit Pro and Quickformables Acor: QuickFit Pro and Quickformables Total contact and heat forming Total contact and heat forming Require sizing (come in a three size range) and modification (at an extra cost for materials AND labor) Require sizing (come in a three size range) and modification (at an extra cost for materials AND labor) Difficult to change after initial fabrication Difficult to change after initial fabrication Reduce fabrication time and cost Reduce fabrication time and cost Inadequate durability and performance compared to custom inserts Inadequate durability and performance compared to custom inserts

Proposed Product Manufactured, four-layered, modifiable orthotic insert for the general diabetic patient with neuropathy and foot deformation Manufactured, four-layered, modifiable orthotic insert for the general diabetic patient with neuropathy and foot deformation –all sizes –Perforated from the bottom up to quickly offload areas of high pressure –Removed sections of cork can be reattached to previous location or can be used to build up another area –Head-molding capabilities make the insert total contact

Costs and Safety Proposed Cost: $40/pair; compare to current $260/pair for custom and $25/pair for Acor Quikfit Proposed Cost: $40/pair; compare to current $260/pair for custom and $25/pair for Acor Quikfit Proposed Budget: $300 due to F Scan sensor and materials Proposed Budget: $300 due to F Scan sensor and materials Safety: Safety: Foam bottoming out-test to determine useful life and provide warnings User modification-warnings and education Improper modification by provider-sell only to licensed physicians and pedorthists FDA Class I Device: no 501(k) necessary, must submit Good Manufacturing Practices

F-scan Provides bipedal plantar pressure and force measurements on the feet using paper-thin reusable sensors placed in shoes. Provides bipedal plantar pressure and force measurements on the feet using paper-thin reusable sensors placed in shoes. The actual sensor is a resistive sensor with a resolution of 0.25 cm 2 The actual sensor is a resistive sensor with a resolution of 0.25 cm 2 This is a key factor in quantifying the results of the pressure offloading of our insert. This is a key factor in quantifying the results of the pressure offloading of our insert.

Materials

Material Heat Formable Temperature (F) Durometer (Shore) Minimum Thickness AvailableAdditional Benefits P-Cell /16"Top layer, serves to control friction Plastazote /16" Puff Lite250251/8" BirkoCork325-5 mmstability and durability Cushion Cork--1/16" Multi-Cork /8" NORA EVA mm SPENCO-401/16"shock absorption, shear force maintenance MicroCell Puff /16" Poron14-551/16"pure shock absorbance

Material Experimentation Compare and contrast vertical plantar pressure measurements (pressure vs. time) during normal gait Compare and contrast vertical plantar pressure measurements (pressure vs. time) during normal gait Compare five inserts to determine if fourth layer is necessary and which material is most easily perforated and provides the best offloading Compare five inserts to determine if fourth layer is necessary and which material is most easily perforated and provides the best offloading Pressure conversion factor given as one unit to 1.4 psi Pressure conversion factor given as one unit to 1.4 psi White Plastizote base offloads the most, but cork is almost as good and MUCH easier to perforate White Plastizote base offloads the most, but cork is almost as good and MUCH easier to perforate Blue Line: New Balance Insert Green Line: White Plastizote and Spenco Pink Line: Cork and Diabetic Tri-lam Black Line: P-Lite and Diabetic Tri-lam Red Line: White Plastizote and Diabetic Tri-lam Time (ms) Vertical Plantar Pressure

Shape of Perforation Test perforation schemes with static tests on loaded first metatarsal head on diabetic tri-lam (1/8 inch layers) with no base layer Test perforation schemes with static tests on loaded first metatarsal head on diabetic tri-lam (1/8 inch layers) with no base layer Dual layer perforation shown to be best-base layer and Puff Dual layer perforation shown to be best-base layer and Puff Pressure conversion is one unit to 1.4 psi Pressure conversion is one unit to 1.4 psi Red line: Diamond perforations Blue line: Circular perforations Black line: Diamond perforations below circular perforations In order to fit into standard extra-depth shoe, we will use 1/8” of Pink Plastizote and Poron on top of 1/16” Puff with a standard shaped cork base In order to fit into standard extra-depth shoe, we will use 1/8” of Pink Plastizote and Poron on top of 1/16” Puff with a standard shaped cork base Time (ms) Vertical Plantar Pressure

Conclusions There is a rapidly increasing market for diabetic footwear. There is a rapidly increasing market for diabetic footwear. –Many patients cannot afford necessary footwear. The current process of orthotic customization is labor intensive, expensive, and unavailable to rural patients. The current process of orthotic customization is labor intensive, expensive, and unavailable to rural patients. –The cost and availability can be optimized by minimizing labor. The use of surface depressions is a common method of offloading used in industry. The use of surface depressions is a common method of offloading used in industry. –Perforations address this need and allow modifications. Recommendation: Project can be continued to develop a “smart” insert that records pressures during the day and alerts patients of potentially dangerous plantar pressures. Recommendation: Project can be continued to develop a “smart” insert that records pressures during the day and alerts patients of potentially dangerous plantar pressures.