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Offloading Device for the Reduction of Foot Complications in Diabetic Patients

Offloading Device for the Reduction of Foot Complications in Diabetic Patients. Michael Osborne Rod Aliabadi Patrick Gonzales Colin Smith. Diabetes and the Effects. Affects 20.8 million Americans Insufficient insulin production or action Neuropathy Foot deformation Poor circulation

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Offloading Device for the Reduction of Foot Complications in Diabetic Patients

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  1. Offloading Device for the Reduction of Foot Complications in Diabetic Patients • Michael Osborne • Rod Aliabadi • Patrick Gonzales • Colin Smith

  2. Diabetes and the Effects • Affects 20.8 million Americans • Insufficient insulin production or action • Neuropathy • Foot deformation • Poor circulation • 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 • One pair of depth-inlay shoes and three pairs of inserts • One pair of custom molded shoes with inserts • If… • Diabetes, amputation, past ulceration, calluses, neuropathy, poor circulation…

  6. Orthotic Insert Specifications • Inexpensive-Minimize Labor Costs • Versatile-Manufacture it to fit any standard extra depth shoe; numerous built in modifications • 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 • 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 Budget: ~$500 due to F Scan sensor, materials, professionally constructed prototype? • Schedule: Experimental Setup Now-Early Feb. Final Design Issues Feb.-Early March Prototype Design March-Early April Testing/Modification April

  9. Experimental overview

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

  11. Methods • All Testing done through F-scan GAIT analysis • Test individual materials for off-loading • 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

  12. Analysis • 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). • 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. • 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. • The actual sensor is a resistive sensor with a resolution of 4 Sensors per cm2 • 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. • Use for analysis of diabetic inserts. • Identifying ideal design and material selection www.tekscan.com

  16. Conclusions • 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 cost can be minimized by minimizing labor. • The use of surface depressions is a common method of offloading used in industry. • Perforated sections should address this need.

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