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Journal of Foot and Ankle Research
Published in: Journal of Foot and Ankle Research 1/2012

Open Access 01-12-2012 | Research

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

Authors: Joanne S Paton, Elizabeth A Stenhouse, Graham Bruce, Daniel Zahra, Ray B Jones

Published in: Journal of Foot and Ankle Research | Issue 1/2012

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Abstract

Background

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.

Method

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.

Results

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.

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.

Trial registration

Clinical trials.gov (NCT00999635). Note: this trial was registered on completion.
Appendix
Available only for authorised users
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Metadata
Title
A comparison of customised and prefabricated insoles to reduce risk factors for neuropathic diabetic foot ulceration: a participant-blinded randomised controlled trial
Authors
Joanne S Paton
Elizabeth A Stenhouse
Graham Bruce
Daniel Zahra
Ray B Jones
Publication date
01-12-2012
Publisher
BioMed Central
Published in
Journal of Foot and Ankle Research / Issue 1/2012
Electronic ISSN: 1757-1146
DOI
https://doi.org/10.1186/1757-1146-5-31

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