Investigation into insoles to reduce risk of ulceration in people with diabetes
Neuropathic diabetic foot ulceration may be prevented if the mechanical stress transmitted to the foot is reduced when walking. Insole therapy is one practical method commonly used to reduce loads under the foot and ulceration risk. The type of insole best suited to achieve this aim is unknown. This series of related research evaluates the effectiveness of insoles for people with diabetes and neuropathy.
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Paton J, Stenhouse E, Bruce G, Jones R. A comparison of functional and prefabricated insoles to reduce risk factors for neuropathic diabetic foot ulceration: a single blind randomised control trial. Journal of Foot and Ankle Research.  2012,
This trial compared custom-made functional insoles with prefabricated insoles to reduce risk factors for ulceration of neuropathic diabetic feet.
Method: 119 neuropathic participants with diabetes were randomly allocated to custom-made functional or prefabricated insoles. Data were collected at insole issue and six month follow-up using the F-scan in-shoe pressure measurement system.
Results: There were no differences in peak pressure between insoles. The custom-made functional insole was slightly more effective than the prefabricated insole in reducing forefoot pressure time integral at issue (27% vs. 22%), remained more effective at six month follow-up (30% vs. 24%),p=0.001), but was more expensive (UK £656 vs. £554, p<0.001). Cost comparison of insole provision included direct and indirect costs, that is the price of the insoles, staff time and participant attendance and travel cost.
There was no difference in patient perception between insoles.
Conclusion: The custom-made insoles are more expensive than prefabricated insoles evaluated in this trial and no better in reducing peak pressure. We recommend that where clinically appropriate, the more cost effective prefabricated insole should be considered for use by patients with diabetes and neuropathy.
Paton J, Stenhouse E, Jones R, Bruce G. 2007. Custom-made total contact insoles and prefabricated functional diabetic insoles: A case report. The Diabetic Foot Journal. 10 (3) 138-143
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We report on a comparison of the two insoles in the case of a 54-year-old lady with type 2 diabetes and peripheral neuropathy, presenting with ulceration overlying the third metatarsal region. The F-scan in-shoe pressure measurement system (TEKSCAN) provided an objective measure of effect.
Conclusion: 1) Assessment of foot structure and biomechanical dysfunction is crucial to prescribing load-reducing insoles for diabetic individuals. 2) In-shoe pressure measurement systems can instantly compare and optimise offloading interventions with limited patient risk. 3) This case study showed the prefabricated functional insole (Interpod Diabetic Algeo Ltd) as a successful alternative to total contact insoles, benefiting the low-arched pronated neuropathic diabetic foot.
Paton J, Bruce G, Jones R, Stenhouse E. 2011. Effectiveness of insoles used for the prevention of ulceration in the neuropathic diabetic foot: a systematic review. Journal of Diabetes and its Complications. 25, 52-62.
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Scope of the Review: This review evaluated the effectiveness of insoles used for the prevention of ulcer in the neuropathic diabetic foot.
Methods: Databases were searched from inception to 2008,
Results: A total of five trials met the inclusion criteria: two randomised control trials (RCTs), two case control studies, and one follow-up study. The methodological quality of  the majority of studies was poor. There is a small amount of limited evidence indicating that insoles are effective in reducing incidence of ulceration and reducing plantar peak pressures in the diabetic neuropathic foot.
Conclusions: Insoles appear of use for the prevention of neuropathic diabetic foot ulceration, although evidence is limited. Clinical recommendation regarding type and specification of insole is not possible at this time. There is an essential need for a large well-designed RCT comparing different types of commonly used insole for the prevention of ulceration in the diabetic neuropathic foot. Outcome measures should include patient perceptions of the effectiveness and cost-effectiveness analysis.
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Paton J, Jones R, Stenhouse E, Bruce G. 2007 The physical characteristics of orthotic materials used in the manufacture of orthosis for patients with diabetes. Foot and Ankle International. 28 (10) 1057-1063.
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Published research evaluating the physical properties of materials commonly used in the manufacture of orthoses for patients with diabetes is limited. This study investigated the physical properties of materials used to fabricate orthoses designed for the prevention of neuropathic diabetic foot ulcers.
Methods: Fifteen commonly used orthotic materials we      re selected for testing. The density, resilience, stiffness, static coefficient of friction, durability, and compression set of each material were tested, ranked, and allocated a performance indicator score.
Results: The most clinically desirable dampening materials tested were Poron® 96 (6-mm) and Poron® 4000 (6-mm). High density EVA (Algeo Ltd., Liverpool, UK) and Lunacell Nora® EVA (Freudenberg, Weinhein, Germany) possessed the properties most suitable to achieve motion control. The data present a simple and useful comparison and classification of the selected materials.
Conclusions: Although this information should not be used as a single indicator for assessing the suitability of an orthotic material, the results provide clinically relevant information relating to the physical properties of orthotic materials commonly used in the prevention of neuropathic diabetic foot ulcers.