Can Smart Orthotics Have An Impact In Preventing Ulceration?

Start Page: 28

   “While this is, in principle, an attractive concept, I think the reality is that the cost of a system like this would make it unappealing to both patients and healthcare providers,” notes Dr. Davis.


If smart orthotics become available, do you think the insurance companies will cover the expenses related to the use of these devices?


Dr. Davis says the key to insurance coverage is validating the cost-effectiveness of new solutions such as smart orthoses. He says double-blind studies are necessary to compare orthotics with smart orthotics, and longitudinal studies are necessary for matched patient cohorts with the endpoint of a documented reduction in ulcer incidence. Dr. Davis notes such studies are relatively expensive as they require well over 100 patients per group, with each group usually needing to be tracked for 12 to 24 months.

   “With this said, there is probably no easier approach to reduce ulcers than one that focuses on the use of appropriate footwear,” offers Dr. Davis.

   If the profession confirms that smart orthotics are more effective than present orthotic devices, Dr. Yavuz advocates that insurance companies should cover them. Given the high cost of the diabetic foot and amputations, he says if smart orthotics have reasonable purchase and maintenance costs, they can present a “win-win situation for all parties,” including patients, healthcare providers and insurance companies.

   Dr. Erdemir is uncertain that insurance companies will cover smart orthotic devices. However, he feels establishing the efficacy of orthotics to prevent foot ulceration and an analysis of cost savings associated with prevention via footwear prescription are necessary steps that can encourage policy makers and insurance companies to adopt such practices.

   Dr. Davis is the Vice President and Director of the Medical Device Development Center at the Austen BioInnovation Institute in Akron, Ohio.

   Dr. Erdemir is the Director of the Computational Biomodeling Core and a Staff Scientist in the Department of Biomedical Engineering/ND-20 at Lerner Research Institute in Cleveland, Ohio.

   Dr. Yavuz is an Assistant Professor in the Department of Basic Sciences at the Ohio College of Podiatric Medicine.


1. Bus SA, Valk GD, van Deursen RW, et al. The effectiveness of footwear and offloading interventions to prevent and heal foot ulcers and reduce plantar pressure in diabetes: a systematic review. Diabetes Metab Res Rev 2008;24 Suppl 1:S162-80.
2. Yavuz M, Erdemir A, Botek G, et al. Peak pressure and shear locations under the foot: relevance to diabetic patients. Diabetes Care 2007; 30(10):2643-5.
3. Mueller MJ, Zou D, Lott DJ. Pressure gradient as an indicator of plantar skin injury. Diabetes Care 2005 Dec;28(12):2908-12.
4. Cavanagh PR, Erdemir A and Petre M. A finite element approach to examine the relationship between plantar pressure and internal stress in the foot, 54th Annual Meeting of the Orthopaedic Research Society, March 2-5, 2008, San Francisco, CA.
5. Lavery LA, Armstrong DG, Wunderlich RP, et al. Predictive value of foot pressure assessment as part of a population-based diabetes disease management program. Diabetes Care 2003; 26(4):1069-73.
6. Hsi WL, Ulbrecht JS, Perry JE, et al. Plantar pressure threshold for ulceration risk using the EMEDSF platform [abstract]. Diabetes 1993; 42(S1):103a.
7. Murray HJ, Young MJ, Hollis S, et al. The association between callus formation, high pressures and neuropathy in diabetic foot ulceration. Diabet Med. 1996 Nov;13(11):979-82.
8. Yavuz M, Tajaddini A, Botek G, et al. Temporal characteristics of plantar shear distribution: relevance to diabetic patients. J Biomech. 2008;41(3):556-9.
9. Brand PW. Tenderizing the foot. Foot Ankle Int 2003; 24(6):457-61.

image description image description

Post new comment

  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.

More information about formatting options

Enter the characters shown in the image.