Today's post comes from jfootankleres.com (see link below) and looks at a specific problem for people trying to find the best sorts of footware to support feet with neuropathy (especially those prone to foot ulcers). Many people pay for expensive custom-made insoles but the trial described here comes to the conclusion that there's little to no difference with ordinary shop-bought insoles. It may mean trying on every shoe in the shop and then trying out various insoles to give further support but if you have neuropathic foot problems, you know it's worth taking the greatest care of your feet.
a participant-blinded randomised controlled trial
Joanne S Paton, Elizabeth A Stenhouse, Graham Bruce, Daniel Zahra and Ray B Jones
Journal of Foot and Ankle Research 2012, Published: 5 December 2012
Abstract (provisional)
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 6.56 pounds vs. 5.54 pounds, p=less than 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.
ConclusionThe 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.
The complete article is available as a provisional PDF. The fully formatted PDF and HTML versions are in production.
