A comparison of customised and prefabricated insoles to reduce risk factors for neuropathic diabetic foot ulceration: a participant-blinded randomised controlled trial
dc.contributor.author | Paton, Joanne | |
dc.contributor.author | Stenhouse, EA | |
dc.contributor.author | Bruce, G | |
dc.contributor.author | Zahra, Daniel | |
dc.contributor.author | Jones, Ray | |
dc.date.accessioned | 2017-03-29T09:01:35Z | |
dc.date.available | 2017-03-29T09:01:35Z | |
dc.date.issued | 2012-12 | |
dc.identifier.issn | 1757-1146 | |
dc.identifier.issn | 1757-1146 | |
dc.identifier.other | 31 | |
dc.identifier.uri | http://hdl.handle.net/10026.1/8725 | |
dc.description.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. | |
dc.format.extent | 31- | |
dc.format.medium | Electronic | |
dc.language | en | |
dc.language.iso | eng | |
dc.publisher | Springer Science and Business Media LLC | |
dc.subject | Clinical Trials and Supportive Activities | |
dc.subject | Neurosciences | |
dc.subject | Diabetes | |
dc.subject | Clinical Research | |
dc.subject | Peripheral Neuropathy | |
dc.subject | Neurodegenerative | |
dc.subject | 6.3 Medical devices | |
dc.subject | 3.2 Interventions to alter physical and biological environmental risks | |
dc.subject | Metabolic and endocrine | |
dc.subject | Musculoskeletal | |
dc.title | A comparison of customised and prefabricated insoles to reduce risk factors for neuropathic diabetic foot ulceration: a participant-blinded randomised controlled trial | |
dc.type | journal-article | |
dc.type | Journal Article | |
plymouth.author-url | https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000314610300001&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=11bb513d99f797142bcfeffcc58ea008 | |
plymouth.issue | 1 | |
plymouth.volume | 5 | |
plymouth.publication-status | Published | |
plymouth.journal | Journal of Foot and Ankle Research | |
dc.identifier.doi | 10.1186/1757-1146-5-31 | |
plymouth.organisational-group | /Plymouth | |
plymouth.organisational-group | /Plymouth/Faculty of Health | |
plymouth.organisational-group | /Plymouth/Faculty of Health/Peninsula Medical School | |
plymouth.organisational-group | /Plymouth/Faculty of Health/School of Health Professions | |
plymouth.organisational-group | /Plymouth/Faculty of Health/School of Nursing and Midwifery | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA/UoA03 Allied Health Professions, Dentistry, Nursing and Pharmacy | |
plymouth.organisational-group | /Plymouth/Research Groups | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Health and Community | |
plymouth.organisational-group | /Plymouth/Research Groups/Plymouth Institute of Health and Care Research (PIHR) | |
plymouth.organisational-group | /Plymouth/Users by role | |
plymouth.organisational-group | /Plymouth/Users by role/Academics | |
plymouth.organisational-group | /Plymouth/Users by role/Researchers in ResearchFish submission | |
dc.publisher.place | England | |
dcterms.dateAccepted | 2012-11-19 | |
dc.identifier.eissn | 1757-1146 | |
dc.rights.embargoperiod | No embargo | |
rioxxterms.versionofrecord | 10.1186/1757-1146-5-31 | |
rioxxterms.licenseref.uri | http://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.licenseref.startdate | 2012-12-05 | |
rioxxterms.type | Journal Article/Review |