1. 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

2. 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 Foot deformation Foot deformation Poor circulation Poor circulation Decreased healing Decreased healing

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

4. “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

5. Is There a Legit Market? $27,987 20.8 million people 6% incidence = $34,927,776,000

6. How Does Medicare Fit into the Picture? Two options –O–O–O–One pair of depth-inlay shoes and three pairs of inserts –O–O–O–One pair of custom molded shoes with inserts If… –D–D–D–Diabetes, amputation, past ulceration, calluses, neuropathy, poor circulation…

7. Orthotic Insert Specifications Inexpensive-Minimize Labor Costs Inexpensive-Minimize Labor Costs Versatile-Manufacture it to fit any standard extra depth shoe; numerous built in modifications Versatile-Manufacture it to fit any standard extra depth shoe; numerous built in modifications Preventative-Minimize vertical plantar pressure and incidence of wounds Preventative-Minimize vertical plantar pressure and incidence of wounds

8. Current Technology Acor makes QuickFit Pro and Quickformables Acor makes QuickFit Pro and Quickformables Both are total contact and heat forming Both are total contact and heat forming Require sizing (come in a three size range) and modification (at an extra cost for materials AND labor) by pedorthist Require sizing (come in a three size range) and modification (at an extra cost for materials AND labor) by pedorthist Difficult to change after initial fabrication Difficult to change after initial fabrication These technologies do reduce the time of fabrication. These technologies do reduce the time of fabrication. However, better inserts can be made in even less time. However, better inserts can be made in even less time.

9. Proposed Product Manufactured, multilayered, and modifiable orthotic insert for the general diabetic patient with neuropathy and foot deformation Manufactured, multilayered, and modifiable orthotic insert for the general diabetic patient with neuropathy and foot deformation –all sizes –perforated from the bottom up to offload typical high pressure areas (i.e. the heel, first and fifth metatarsal heads) –Removed sections can be reattached later if necessary. –Plastizote foam top layer allows insert to be heat molded if necessary –Pedorthist must make modifications (Medicare coverage). –As durable and less expensive than current customized inserts.

10. Costs and Schedule Proposed Cost of Final Product: $50- 100/pair; compare to current $260/pair Proposed Cost of Final Product: $50- 100/pair; compare to current $260/pair Proposed Budget: ~$500 due to F Scan sensor, materials, professionally constructed prototype? Proposed Budget: ~$500 due to F Scan sensor, materials, professionally constructed prototype? Schedule: Schedule: Experimental SetupNow-Early Feb. Final Design IssuesFeb.-Early March Prototype DesignMarch-Early April Testing/ModificationApril

11. Experimental overview

12. Materials

13. Material Heat Formable Temperature (F) Durometer (Shore) Minimum Thickness AvailableAdditional Benefits P-Cell250-27520-251/16"Top layer, serves to control friction Plastazote250-285201/16" Puff Lite250251/8" BirkoCork325-5 mmstability and durability Cushion Cork--1/16" Multi-Cork300-32550-631/8" NORA EVA-181.5 mm SPENCO-401/16"shock absorption, shear force maintenance MicroCell Puff275-300351/16" Poron14-551/16"pure shock absorbance

14. Analysis Compare and contrast vertical plantar pressure measurements (force vs. time, pressure vs. time). Compare and contrast vertical plantar pressure measurements (force vs. time, pressure vs. time). Test to see if extra thickness is more effective in terms of offloading (2 layers versus 3). Test to see if extra thickness is more effective in terms of offloading (2 layers versus 3). Compare the materials used and layer combinations for best combined grouping. Compare the materials used and layer combinations for best combined grouping.

15. Shape and Depth of Perforation Test varying shape of perforations. Test varying shape of perforations. Current ideas: diamond, triangular, and circular removable perforations in the lower layer. Current ideas: diamond, triangular, and circular removable perforations in the lower layer. Dual layer perforated design. Dual layer perforated design.

16. 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 4 Sensors per cm 2 The actual sensor is a resistive sensor with a resolution of 4 Sensors per cm 2 This will be a key factor in quantifying the results of the pressure offloading of our insert. This will be a key factor in quantifying the results of the pressure offloading of our insert. www.tekscan.com

17. 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 very labor intensive and, therefore, expensive. The current process of orthotic customization is very labor intensive and, therefore, expensive. –The cost can be minimized 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. –Perforated sections should address this need.