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. “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

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

5. 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…

6. 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

7. 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 (using sections of two-sided tape??). –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.

8. 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

9. Experimental overview

10. Materials P-Cell Multi-Cell Puff Cork Poron

11. Methods All Testing done through F-scan GAIT analysis All Testing done through F-scan GAIT analysis Test individual materials for off- loading Test individual materials for off- loading Layer Materials to test combined efficacy Layer Materials to test combined efficacy Key point: This is a single variable experiment the plaster foot model will be the only tested “foot” platform Key point: This is a single variable experiment the plaster foot model will be the only tested “foot” platform

12. 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.

13. How to Obtain Quantitative Results With so many currently available inserts, we need to show the benefits of ours. With so many currently available inserts, we need to show the benefits of ours. Show that the insert is able to be customized while offload peak pressures on the foot. Show that the insert is able to be customized while offload peak pressures on the foot.

14. 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

15. Available F-Scan Systems F-Scan available at the Belmont GAIT lab. F-Scan available at the Belmont GAIT lab. Use for analysis of diabetic inserts. Use for analysis of diabetic inserts. Identifying ideal design and material selection Identifying ideal design and material selection www.tekscan.com

16. 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.