INSoles To Ease Pressure (INSTEP) Study: a multicentre, randomised controlled feasibility study to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy: a study protoco
dc.contributor.author | Collings, Richard | |
dc.contributor.author | Freeman, Jennifer | |
dc.contributor.author | Latour, Jos M | |
dc.contributor.author | Glasser, S | |
dc.contributor.author | Vickery, PJ | |
dc.contributor.author | Enki, Doyo Gragn | |
dc.contributor.author | Lepesis, V | |
dc.contributor.author | Paton, Joanne | |
dc.date.accessioned | 2019-03-22T12:16:41Z | |
dc.date.issued | 2019-03-23 | |
dc.identifier.issn | 2044-6055 | |
dc.identifier.issn | 2044-6055 | |
dc.identifier.other | ARTN e029185 | |
dc.identifier.uri | http://hdl.handle.net/10026.1/13517 | |
dc.description.abstract |
<jats:sec><jats:title>Introduction</jats:title><jats:p>Foot ulceration is a multifactorial complication of diabetes. Therapeutic insoles and footwear are frequently used to reduce elevated tissue pressures associated with risk of foot ulceration. A novel protocol using in-shoe pressure measurement technology to provide an instant optimised insole and house shoe solution has been developed, with the aim of reducing foot ulceration.</jats:p></jats:sec><jats:sec><jats:title>Aim</jats:title><jats:p>This study aims to assess the feasibility of conducting a multicentre randomised controlled trial to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy.</jats:p></jats:sec><jats:sec><jats:title>Methods and analysis</jats:title><jats:p>This study is a participant and assessor blinded, randomised, multicentre parallel group feasibility trial with embedded qualitative study. Seventy-six participants will be recruited from three podiatry clinics and randomised to an optimised insole plus usual care (intervention group) or standard insole plus usual care (control group) using a minimisation by randomisation procedure by study centre and previous ulcer status. Assessment visits and data collection will be at baseline, 3 months, 6 months and 12 months. Feasibility and acceptability of the trial procedures will be determined in terms of recruitment and retention rates, data completion rates, intervention adherence and effectiveness of the blinding.</jats:p><jats:p>Assessment of the appropriateness and performance of outcome measures will inform selection of the primary and secondary outcomes and sample size estimate for the anticipated definitive randomised controlled trial. Clinical outcomes include incidence of plantar foot ulceration and change in peak plantar pressure. Twelve participants (four from each centre) and three treating podiatrists (one from each centre) will be interviewed to explore their experiences of receiving and delivering the intervention.</jats:p></jats:sec><jats:sec><jats:title>Ethics and dissemination</jats:title><jats:p>The study was approved by the South-West Exeter Research Ethics Committee. Findings will be disseminated through conference presentations, public platforms and academic publications.</jats:p></jats:sec><jats:sec><jats:title>Trials registration number</jats:title><jats:p>ISRCTN16011830; Pre-results.</jats:p></jats:sec> | |
dc.format.extent | e029185-e029185 | |
dc.format.medium | Electronic | |
dc.language | en | |
dc.language.iso | en | |
dc.publisher | BMJ Publishing Group | |
dc.subject | diabetic foot | |
dc.subject | primary care | |
dc.subject | qualitative research | |
dc.subject | Adult | |
dc.subject | Aged | |
dc.subject | Aged, 80 and over | |
dc.subject | Diabetes Mellitus | |
dc.subject | Diabetic Foot | |
dc.subject | Diabetic Neuropathies | |
dc.subject | Feasibility Studies | |
dc.subject | Female | |
dc.subject | Foot | |
dc.subject | Foot Orthoses | |
dc.subject | Humans | |
dc.subject | Male | |
dc.subject | Middle Aged | |
dc.subject | Pressure | |
dc.subject | Shoes | |
dc.subject | Young Adult | |
dc.title | INSoles To Ease Pressure (INSTEP) Study: a multicentre, randomised controlled feasibility study to compare the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy: a study protoco | |
dc.type | journal-article | |
dc.type | Comparative Study | |
dc.type | Journal Article | |
dc.type | Randomized Controlled Trial | |
dc.type | Research Support, Non-U.S. Gov't | |
plymouth.author-url | https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000471144900328&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=11bb513d99f797142bcfeffcc58ea008 | |
plymouth.issue | 3 | |
plymouth.volume | 9 | |
plymouth.publication-status | Published | |
plymouth.journal | BMJ Open | |
dc.identifier.doi | 10.1136/bmjopen-2019-029185 | |
plymouth.organisational-group | /Plymouth | |
plymouth.organisational-group | /Plymouth/Faculty of Health | |
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/Institute of Translational and Stratified Medicine (ITSMED) | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)/CBBB | |
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 | 2019-01-24 | |
dc.rights.embargodate | 2019-3-27 | |
dc.identifier.eissn | 2044-6055 | |
dc.rights.embargoperiod | Not known | |
rioxxterms.versionofrecord | 10.1136/bmjopen-2019-029185 | |
rioxxterms.licenseref.uri | http://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.licenseref.startdate | 2019-03-23 | |
rioxxterms.type | Journal Article/Review | |
plymouth.funder | Reducing Foot Plantar Pressure (ReFPres) in people with diabetes using an instant insole solution: a mixed methods pilot study::National Institute of Health and Medical Research |