[{"data":1,"prerenderedAt":361},["ShallowReactive",2],{"content-site-settings":3,"content-\u002Fabout":49,"recruitment-data":160,"locations-data-[object Object]":243,"map-data-[object Object]":352},{"id":4,"extension":5,"meta":6,"stem":47,"__hash__":48},"dataFiles\u002Fdata\u002Fsite.json","json",{"en":7},{"siteDetails":8,"cookieControl":12,"siteLogo":16,"mainNav":21,"preNav":35,"stickyNav":36,"footerContent":37},{"organisationName":9,"siteName":10,"siteUrl":11},"University of Birmingham","FREMS Study Site","https:\u002F\u002Ffrems-study.digitrial.com\u002F",{"cookieModalTitle":13,"cookieModalText":14,"nonNecessaryCookiesUsed":15},"Cookies used on this site","This website only uses non-necessary cookies to remember where you are in the process and to learn about how people view the information. We do NOT use cookies that directly identify anyone. For the best experience please click Accept all below.",true,{"url":17,"alt":18,"width":19,"height":20},"frems-logo.svg","Home",160,null,[22,25,29,32],{"title":23,"url":24},"Taking part","\u002Ftaking-part",{"title":26,"url":27,"target":28,"external":28},"About the study","\u002Fabout\u002F",false,{"title":30,"url":31},"Resources","\u002Fresources\u002F",{"title":33,"url":34,"target":28,"external":28},"Contact","\u002Fcontact\u002F",[],[],{"footerLogo":38,"footerCol1":43,"footerCol2":44,"footerCol3":45,"additionalInfo":46},{"url":39,"alt":40,"width":41,"height":42},"frems-footer-logo.svg","FREMS-PDPN study logo",352,180,"**Address**\\\nBirmingham Clinical Trials Unit\nPublic Health Building\nUniversity of Birmingham\nBirmingham B15 2TT","**Telephone**\\\n+44 (0)121 415 9128\n\n**Email**\\\nfrems-pdpn@trials.bham.ac.uk\n\n**Social**\\\n\u003Ca href=\"https:\u002F\u002Ftwitter.com\u002Ffrems_pdpn\" target=\"_blank\">Twitter\u003C\u002Fa>","[Privacy policy](\u002Fprivacy)\n[Cookie policy](\u002Fcookies)\n[Accessibility statement](\u002Faccessibility)\n[Site map](\u002Fsite-map)","This study is funded by the National Institute for Health Research (NIHR) Heath Technology Assessment programme (project reference NIHR133599). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.\n\nThis is a digitrial site made by morph.co.uk.","data\u002Fsite","QR5K9ahYGZL5PI7YZmCR5PWFEX7nQcULbzd1RZ6iEQo",{"id":50,"title":26,"body":20,"description":20,"extension":5,"meta":51,"navigation":15,"path":156,"seo":157,"stem":158,"__hash__":159},"contentPages\u002Fpages\u002Fabout.en.json",{"pageTitle":26,"pageMetadata":52,"page_content":53},{"htmlTitle":26,"htmlDesc":26},[54,64,76,83,90,117],{"type":55,"title":56,"text":57,"image":58,"sectionSettings":63},"page_header","# About the study","PDPN affects 25% of people with diabetes and 70% of sufferers have moderate-to-severe pain. PDPN is associated with sleep disruption, poor quality of life (QoL), unemployment & depression",{"url":59,"alt":60,"width":61,"height":62},"frems-header-image-4.svg","",1000,655,{"sectionLabel":26},{"type":65,"settings":66,"title":69,"text":70,"image":71,"sectionSettings":74},"text_and_image",{"imgWidth":67,"imgPosition":68},"half-width","top","## Aim of the study","The study aims to evaluate the efficacy of FREMS (Frequency Rhythmic Electrical Modulated System) in patients with painful diabetic peripheral neuropathy (PDPN, painful feet from nerve damages caused by diabetes) who have not responded to the NICE (National Institute for Health and Care Excellence) recommended treatments. FREMS delivers electrical pulses via stickers that are placed on the feet and legs; these pulses can reduce the pain in patients with PDPN.",{"url":72,"alt":60,"width":61,"height":73},"frems-content-image-5-1000w.png",653,{"sectionLabel":75},"Aim of the study",{"type":77,"text":78,"componentName":79,"sectionSettings":80},"text_and_component","## Current enrolment curve","StudyRecruitmentChart",{"sectionLabel":81,"textAlign":82},"Current enrolment curve","center",{"type":77,"text":84,"componentName":85,"componentOptions":86,"sectionSettings":88},"## Locations","StudyLocationsMap",{"mapTitle":87},"UK",{"sectionLabel":89,"textAlign":82},"Study locations map",{"type":91,"settings":92,"text":96,"cards":97,"sectionSettings":115},"text_and_cards",{"headerLevel":93,"headerFontSize":93,"maxCardsPerRow":93,"wholeClickable":15,"cardTheme":94,"numberedCards":28,"alignCards":95,"alignCardContent":95},"3","white","left","## Study team",[98,105,110],{"type":99,"image":100,"title":103,"summary":104},"card_image_text",{"url":101,"width":102,"height":102},"bf-headshot.jpeg",500,"Dr Bernhard Frank ","**Chief Investigator**\n\nConsultant in Pain Medicine, Walton Centre NHS Foundation Trust. Honorary Clinical Senior Lecturer, University of Liverpool",{"type":99,"image":106,"title":108,"summary":109},{"url":107,"width":102,"height":102},"abd-tahrani-cropped.jpg","Dr Abd Tahrani","**Joint Lead Applicant**\n\nHonorary Professor of Medicine at the University of Birmingham and an Honorary Consultant in Endocrinology, Diabetes and Weight Management at the University Hospitals of Birmingham NHS Foundation Trust.",{"type":99,"image":111,"title":113,"summary":114},{"url":112,"width":102,"height":102},"idphotosh.jpg","Sam Hopkins","**Senior Trial Manager**\n\nSam is a senior trial manager at Birmingham Clinical Trials Unit based at the University of Birmingham. She has over 13 years of experience working on clinical trials, in a range of different specialities in both an NHS and academic setting.",{"sectionLabel":116,"textAlign":82},"Study Team",{"type":91,"settings":118,"text":120,"cards":121,"sectionSettings":154},{"headerLevel":93,"headerFontSize":93,"maxCardsPerRow":93,"wholeClickable":28,"cardTheme":119,"alignCards":82,"alignCardContent":82},"primary","## Information about the study",[122,129,134,139,144,149],{"type":123,"icon":124,"title":127,"summary":128},"card_icon_text",{"iconName":125,"iconSize":126},"content-cross","xl","Treatments","FREMS and TENS - both give electrical pulses delivered through stickers on the skin.",{"type":123,"icon":130,"title":132,"summary":133},{"iconName":131,"iconSize":126},"content-calendar","Study Duration","3 years",{"type":123,"icon":135,"title":137,"summary":138},{"iconName":136,"iconSize":126},"content-seedling","Study Funders","This study is funded by the NIHR HTA Programme project reference 133599. The study is sponsored by The University of Birmingham.",{"type":123,"icon":140,"title":142,"summary":143},{"iconName":141,"iconSize":126},"content-edit","Study Design","A randomised controlled trial to assess the efficacy of FREMS in patients with PDPN who have significant pain despite trying the NICE recommended treatments.",{"type":123,"icon":145,"title":147,"summary":148},{"iconName":146,"iconSize":126},"content-chart-1","Participant Population and Sample Size","356 adults with PDPN for ≥3 months with significant pain (mean pain Numerical Rating Scale \\[NRS] ≥4 for a week prior to randomisation) despite trying ≥2 different classes of PDPN medications.",{"type":123,"icon":150,"title":152,"summary":153},{"iconName":151,"iconSize":126},"content-pie-chart","Outcome Measures","The main study outcome is pain severity collected by text message from the participants. Other outcomes include QoL, sleep quality, medication changes & value for money.",{"sectionLabel":155,"textAlign":82},"Information about the Study","\u002Fpages\u002Fabout.en",{"title":26},"pages\u002Fabout.en","p7OXQr8Hfj3kw6tfeMkO4XymmM9lq3KayCdMCjbhhE0",{"id":161,"extension":5,"meta":162,"stem":241,"__hash__":242},"dataFiles\u002Fdata\u002Frecruitment.json",{"recruitmentCharts":163},[164],{"chartTitle":165,"recruitmentTarget":166,"chartData":167,"showTargetLine":15},"Current recruitment for The FREMS-PDPN Study","356",{"datasets":168,"labels":201},[169],{"fill":28,"backgroundColor":170,"borderColor":170,"title":171,"label":172,"data":173},"hsla(201, 88%, 27%, 1)","Actual","Actual recruitment",[174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195,196,197,198,199,20,20,20,20,20,20,20,20,20,20,20,20,200],"0","2","9","15","23","33","52","59","67","78","85","90","109","117","127","139","156","167","173","180","189","199","211","213","218","222","306",[202,203,204,205,206,207,208,209,210,211,212,213,214,215,216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231,232,233,234,235,236,237,238,239,240],"Jan, 23","Feb, 23","Mar, 23","Apr, 23","May, 23","Jun, 23","Jul, 23","Aug, 23","Sep, 23","Oct, 23","Nov, 23","Dec, 23","Jan, 24","Feb, 24","Mar, 24","Apr, 24","May, 24","Jun, 24","Jul, 24","Aug, 24","Sep, 24","Oct, 24","Nov, 24","Dec, 24","Jan, 25","Feb, 25","Mar, 25","Apr, 25","May, 25","Jun, 25","Jul, 25","Aug, 25","Sep, 25","Oct, 25","Nov, 25","Dec, 25","Jan, 26","Feb, 26","Mar, 26","data\u002Frecruitment","gA1NyE2gs9CI-hgiV8GyPW3ZO_FAPU-GcGmGGz23yTY",[244,256,268,280,292,304,316,328,340],{"id":245,"title":246,"body":20,"description":20,"extension":5,"map":87,"meta":247,"navigation":15,"path":252,"publishPage":28,"seo":253,"stem":254,"__hash__":255},"locations\u002Flocations\u002Fqueen-elizabeth-birmingham-nhs-foundation-trust.en.json","Birmingham",{"locationName":246,"coords":248,"accordionContent":251},{"lat":249,"lng":250},"52.452410282212","-1.9410232208683165","University Hospitals Birmingham NHS Foundation Trust","\u002Flocations\u002Fqueen-elizabeth-birmingham-nhs-foundation-trust.en",{"title":246},"locations\u002Fqueen-elizabeth-birmingham-nhs-foundation-trust.en","Fxlwd30W2SDVexl5rk1BGipovqFaES-_G8cNeaKMG_8",{"id":257,"title":258,"body":20,"description":20,"extension":5,"map":87,"meta":259,"navigation":15,"path":264,"publishPage":28,"seo":265,"stem":266,"__hash__":267},"locations\u002Flocations\u002Fipswich-east-suffolk-north-essex.en.json","Ipswich",{"locationName":258,"coords":260,"accordionContent":263},{"lat":261,"lng":262},"52.058048517532924","1.1980914108437584","East Suffolk and North Essex NHS Foundation Trust","\u002Flocations\u002Fipswich-east-suffolk-north-essex.en",{"title":258},"locations\u002Fipswich-east-suffolk-north-essex.en","p6HR37Ia7HvmemsDerIp4_Maqdy7XFvE2_3q3do2mqs",{"id":269,"title":270,"body":20,"description":20,"extension":5,"map":87,"meta":271,"navigation":15,"path":276,"publishPage":28,"seo":277,"stem":278,"__hash__":279},"locations\u002Flocations\u002Fliverpool-university-hospital.en.json","Liverpool",{"locationName":270,"coords":272,"accordionContent":275},{"lat":273,"lng":274},"53.40949119376909","-2.9641675181712728","Liverpool University Hospitals NHS Foundation Trust","\u002Flocations\u002Fliverpool-university-hospital.en",{"title":270},"locations\u002Fliverpool-university-hospital.en","4OorTimaICqdOVa00g5x9o5vcudtcMfuxCTOxLsO_ps",{"id":281,"title":282,"body":20,"description":20,"extension":5,"map":87,"meta":283,"navigation":15,"path":288,"publishPage":28,"seo":289,"stem":290,"__hash__":291},"locations\u002Flocations\u002Fkings-college-hospital.en.json","London",{"locationName":282,"coords":284,"accordionContent":287},{"lat":285,"lng":286},"51.46802739215597","-0.09366430110220209","King's College Hospital NHS Foundation Trust","\u002Flocations\u002Fkings-college-hospital.en",{"title":282},"locations\u002Fkings-college-hospital.en","10XAO4jMU5C_rxdPgFdbwYe9frXL7dj2hC4A8aYNX6A",{"id":293,"title":294,"body":20,"description":20,"extension":5,"map":87,"meta":295,"navigation":15,"path":300,"publishPage":28,"seo":301,"stem":302,"__hash__":303},"locations\u002Flocations\u002Fmanchester-university-nhs-foundation-trust.en.json","Manchester",{"locationName":294,"coords":296,"accordionContent":299},{"lat":297,"lng":298},"53.46092933883601","-2.2277178451525828","Manchester University NHS Foundation Trust","\u002Flocations\u002Fmanchester-university-nhs-foundation-trust.en",{"title":294},"locations\u002Fmanchester-university-nhs-foundation-trust.en","dGcvEg-0CStWoRFaidTs1yGhEeiqZ0Ik0imtn0-URI8",{"id":305,"title":306,"body":20,"description":20,"extension":5,"map":87,"meta":307,"navigation":15,"path":312,"publishPage":28,"seo":313,"stem":314,"__hash__":315},"locations\u002Flocations\u002Fnottingham.en.json","Nottingham",{"locationName":306,"coords":308,"accordionContent":311},{"lat":309,"lng":310},"52.991262790124246","-1.1603319631631737","Nottingham University Hospitals NHS Trust","\u002Flocations\u002Fnottingham.en",{"title":306},"locations\u002Fnottingham.en","sc0l_DJLqYLZLjVExvflCLt_ag22jdXEGE_D8k1fqqM",{"id":317,"title":318,"body":20,"description":20,"extension":5,"map":87,"meta":319,"navigation":15,"path":324,"publishPage":28,"seo":325,"stem":326,"__hash__":327},"locations\u002Flocations\u002Fgeorge-elliot-hospital.en.json","Nuneaton",{"locationName":318,"coords":320,"accordionContent":323},{"lat":321,"lng":322},"52.51183548137152","-1.4760764163785924","George Eliot Hospital NHS Trust","\u002Flocations\u002Fgeorge-elliot-hospital.en",{"title":318},"locations\u002Fgeorge-elliot-hospital.en","ghXsx9IfwdGnPTiXYmezzDM0bDYEQWdp7KjchoIH8RA",{"id":329,"title":330,"body":20,"description":20,"extension":5,"map":87,"meta":331,"navigation":15,"path":336,"publishPage":28,"seo":337,"stem":338,"__hash__":339},"locations\u002Flocations\u002Fsouth-warks.en.json","South Warwickshire",{"locationName":330,"coords":332,"accordionContent":335},{"lat":333,"lng":334},"52.48060378519413","-1.421205174062974","South Warwickshire University NHS Foundation Trust","\u002Flocations\u002Fsouth-warks.en",{"title":330},"locations\u002Fsouth-warks.en","ZK2JEoyw6cDbGvsqnzOZj0gngkcbl1XdY2_PQtzFCrQ",{"id":341,"title":342,"body":20,"description":20,"extension":5,"map":87,"meta":343,"navigation":15,"path":348,"publishPage":28,"seo":349,"stem":350,"__hash__":351},"locations\u002Flocations\u002Fwalton.en.json","Walton",{"locationName":342,"coords":344,"accordionContent":347},{"lat":345,"lng":346},"53.46656290827802","-2.9309355470034335","The Walton Centre NHS Foundation Trust","\u002Flocations\u002Fwalton.en",{"title":342},"locations\u002Fwalton.en","L9z9yAgQz_igdLU_SjThWFoQOO3PdwksjoTVFKYCgHE",{"id":353,"title":87,"body":20,"description":20,"extension":5,"meta":354,"navigation":15,"path":357,"seo":358,"stem":359,"__hash__":360},"locationMaps\u002Flocation-maps\u002Fuk.en.json",{"sortByRegions":28,"mapLabel":87,"maxZoomLevel":355,"regions":356,"showOpenForRecruitment":28},6,[],"\u002Flocation-maps\u002Fuk.en",{"title":87},"location-maps\u002Fuk.en","sPHH4GYQUMDrwRQl9uSdFRYgC-bWmSFakLNgCYQOs84",1790615125457]