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dc.contributor.authorPaton, Joanne
dc.contributor.authorStenhouse, EA
dc.contributor.authorBruce, G
dc.contributor.authorZahra, Daniel
dc.contributor.authorJones, Ray
dc.date.accessioned2017-03-29T09:01:35Z
dc.date.available2017-03-29T09:01:35Z
dc.date.issued2012-12
dc.identifier.issn1757-1146
dc.identifier.issn1757-1146
dc.identifier.other31
dc.identifier.urihttp://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.extent31-
dc.format.mediumElectronic
dc.languageen
dc.language.isoeng
dc.publisherSpringer Science and Business Media LLC
dc.subjectClinical Trials and Supportive Activities
dc.subjectNeurosciences
dc.subjectDiabetes
dc.subjectClinical Research
dc.subjectPeripheral Neuropathy
dc.subjectNeurodegenerative
dc.subject6.3 Medical devices
dc.subject3.2 Interventions to alter physical and biological environmental risks
dc.subjectMetabolic and endocrine
dc.subjectMusculoskeletal
dc.titleA comparison of customised and prefabricated insoles to reduce risk factors for neuropathic diabetic foot ulceration: a participant-blinded randomised controlled trial
dc.typejournal-article
dc.typeJournal Article
plymouth.author-urlhttps://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000314610300001&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=11bb513d99f797142bcfeffcc58ea008
plymouth.issue1
plymouth.volume5
plymouth.publication-statusPublished
plymouth.journalJournal of Foot and Ankle Research
dc.identifier.doi10.1186/1757-1146-5-31
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.placeEngland
dcterms.dateAccepted2012-11-19
dc.identifier.eissn1757-1146
dc.rights.embargoperiodNo embargo
rioxxterms.versionofrecord10.1186/1757-1146-5-31
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserved
rioxxterms.licenseref.startdate2012-12-05
rioxxterms.typeJournal Article/Review


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