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01-12-2012 | Research | Uitgave 1/2012 Open Access

Journal of Foot and Ankle Research 1/2012

A comparison of customised and prefabricated insoles to reduce risk factors for neuropathic diabetic foot ulceration: a participant-blinded randomised controlled trial

Journal of Foot and Ankle Research > Uitgave 1/2012
Joanne S Paton, Elizabeth A Stenhouse, Graham Bruce, Daniel Zahra, Ray B Jones
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Electronic supplementary material

The online version of this article (doi:10.​1186/​1757-1146-5-31) contains supplementary material, which is available to authorized users.

Competing interest

The authors declare that they have no competing interest.

Authors’ contributions

JP conceived and conducted the trial, extracted and analysed the data and produced the initial draft manuscript. RJ, ES and GB critically reviewed the design, development and progress of the trial. RJ and ES reviewed the manuscript for academic content and GB reviewed the discipline specific content. DZ helped with the re-analysis of data dealing with reviewers’ concerns on initial submission. All authors read and approved the final manuscript.



Neuropathic diabetic foot ulceration may be prevented if the mechanical stress transmitted to the plantar tissues is reduced. Insole therapy is one practical method commonly used to reduce plantar loads and ulceration risk. The type of insole best suited to achieve this is unknown. This trial compared custom-made functional insoles with prefabricated insoles to reduce risk factors for ulceration of neuropathic diabetic feet.


A participant-blinded randomised controlled trial recruited 119 neuropathic participants with diabetes who were randomly allocated to custom-made functional or prefabricated insoles. Data were collected at issue and six month follow-up using the F-scan in-shoe pressure measurement system. Primary outcomes were: peak pressure, forefoot pressure time integral, total contact area, forefoot rate of load, duration of load as a percentage of stance. Secondary outcomes were patient perceived foot health (Bristol Foot Score), quality of life (Audit of Diabetes Dependent Quality of Life). We also assessed cost of supply and fitting. Analysis was by intention-to-treat.


There were no differences between insoles in peak pressure, or three of the other four kinetic measures. 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). Full compliance (minimum wear 7 hours a day 7 days per week) was reported by 40% of participants and 76% of participants reported a minimum wear of 5 hours a day 5 days per week. There was no difference in patient perception between insoles.


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.

Trial registration

Clinical (NCT00999635). Note: this trial was registered on completion.

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