[{"data":1,"prerenderedAt":395},["ShallowReactive",2],{"content-site-settings":3,"site-map-\u002Fsite-map":49,"site-map-locations":394},{"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",[50,161,181,221,246,318,338,361],{"id":51,"title":26,"body":20,"description":20,"extension":5,"meta":52,"navigation":15,"path":157,"seo":158,"stem":159,"__hash__":160},"contentPages\u002Fpages\u002Fabout.en.json",{"pageTitle":26,"pageMetadata":53,"page_content":54},{"htmlTitle":26,"htmlDesc":26},[55,65,77,84,91,118],{"type":56,"title":57,"text":58,"image":59,"sectionSettings":64},"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":60,"alt":61,"width":62,"height":63},"frems-header-image-4.svg","",1000,655,{"sectionLabel":26},{"type":66,"settings":67,"title":70,"text":71,"image":72,"sectionSettings":75},"text_and_image",{"imgWidth":68,"imgPosition":69},"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":73,"alt":61,"width":62,"height":74},"frems-content-image-5-1000w.png",653,{"sectionLabel":76},"Aim of the study",{"type":78,"text":79,"componentName":80,"sectionSettings":81},"text_and_component","## Current enrolment curve","StudyRecruitmentChart",{"sectionLabel":82,"textAlign":83},"Current enrolment curve","center",{"type":78,"text":85,"componentName":86,"componentOptions":87,"sectionSettings":89},"## Locations","StudyLocationsMap",{"mapTitle":88},"UK",{"sectionLabel":90,"textAlign":83},"Study locations map",{"type":92,"settings":93,"text":97,"cards":98,"sectionSettings":116},"text_and_cards",{"headerLevel":94,"headerFontSize":94,"maxCardsPerRow":94,"wholeClickable":15,"cardTheme":95,"numberedCards":28,"alignCards":96,"alignCardContent":96},"3","white","left","## Study team",[99,106,111],{"type":100,"image":101,"title":104,"summary":105},"card_image_text",{"url":102,"width":103,"height":103},"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":100,"image":107,"title":109,"summary":110},{"url":108,"width":103,"height":103},"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":100,"image":112,"title":114,"summary":115},{"url":113,"width":103,"height":103},"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":117,"textAlign":83},"Study Team",{"type":92,"settings":119,"text":121,"cards":122,"sectionSettings":155},{"headerLevel":94,"headerFontSize":94,"maxCardsPerRow":94,"wholeClickable":28,"cardTheme":120,"alignCards":83,"alignCardContent":83},"primary","## Information about the study",[123,130,135,140,145,150],{"type":124,"icon":125,"title":128,"summary":129},"card_icon_text",{"iconName":126,"iconSize":127},"content-cross","xl","Treatments","FREMS and TENS - both give electrical pulses delivered through stickers on the skin.",{"type":124,"icon":131,"title":133,"summary":134},{"iconName":132,"iconSize":127},"content-calendar","Study Duration","3 years",{"type":124,"icon":136,"title":138,"summary":139},{"iconName":137,"iconSize":127},"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":124,"icon":141,"title":143,"summary":144},{"iconName":142,"iconSize":127},"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":124,"icon":146,"title":148,"summary":149},{"iconName":147,"iconSize":127},"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":124,"icon":151,"title":153,"summary":154},{"iconName":152,"iconSize":127},"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":156,"textAlign":83},"Information about the Study","\u002Fpages\u002Fabout.en",{"title":26},"pages\u002Fabout.en","p7OXQr8Hfj3kw6tfeMkO4XymmM9lq3KayCdMCjbhhE0",{"id":162,"title":163,"body":20,"description":20,"extension":5,"meta":164,"navigation":15,"path":177,"seo":178,"stem":179,"__hash__":180},"contentPages\u002Fpages\u002Faccessibility.en.json","Accessibility statement",{"pageTitle":163,"pageMetadata":165,"page_content":166},{"htmlTitle":163,"htmlDesc":163},[167,172],{"type":56,"title":168,"image":169,"sectionSettings":171},"# Accessibility statement",{"url":170,"alt":61,"width":62,"height":63},"frems-header-image-15.svg",{"sectionLabel":163},{"type":173,"text":174,"sectionSettings":175},"text","This study is committed to ensuring digital accessibility for people with disabilities. We are continually improving the user experience for everyone, and applying the relevant accessibility standards.\n\n## Conformance status\n\nThe \u003Ca href=\"https:\u002F\u002Fwww.w3.org\u002FWAI\u002Fstandards-guidelines\u002Fwcag\u002F\" target=\"_blank\">Web Content Accessibility Guidelines (WCAG)\u003C\u002Fa> define requirements for designers and developers to improve accessibility for people with disabilities. It defines three levels of conformance: Level A, Level AA, and Level AAA. \n\n**This site is conformant with WCAG 2.2 level AA** and **partially conformant with WCAG 2.2 level AAA**. Partially conformant means that some parts of the content do not fully conform to the AAA accessibility standard.\n\n### Specific exceptions to WCAG 2.2 level AA compliance\n\n* Third party frameworks used to build this app - e.g. \u003Ca href=\"https:\u002F\u002Fnuxtjs.org\u002F\" target=\"_blank\">Nuxt\u003C\u002Fa> - may contain some minor accessibility issues which are not editable by Morph. This includes, for instance, CSS loading animations the duration of which has been to set to longer than 5 seconds. We have attempted to ensure that these exceptions do not impact negatively on user experience.\n\n## Accessibility Features\n\n- All page content can be navigated using keyboard only\n- Skip to main content link available on all pages\n- ARIA labels and landmarks for screen reader users\n- Semantic HTML structure throughout\n- Sufficient color contrast ratios (minimum 4.5:1 for normal text)\n- Respects user preferences for reduced motion\n- Form labels and error messages clearly associated with inputs\n- Video content includes transcripts\n- Focus indicators are visible on all interactive elements\n\n## Design Decisions\n\n**Focus Indicators:** We rely on browser default focus indicators rather than custom styling. This approach ensures focus is always visible on all interactive elements and allows user-applied customisation through system-wide assistive technology to work as expected without interference.\n\n**Keyboard Navigation:** When using in-page content links with the keyboard, focus is applied to the target content for screen readers and keyboard users. The page does not auto-scroll to prevent disorientation, allowing users to control their scrolling experience.\n\n## Technical Specifications\n\nThis website's accessibility relies on the following technologies:\n\n- HTML5\n- CSS3\n- JavaScript\n- ARIA (Accessible Rich Internet Applications)\n\nThe website is designed to be compatible with assistive technologies including screen readers.\n\n## Testing\n\nThis website has been tested for accessibility using:\n\n- Keyboard-only navigation\n- Multiple screen readers (NVDA, VoiceOver)\n- Automated testing tools\n- Manual testing against WCAG 2.2 Level AA and AAA criteria\n\nWe have made every effort to ensure that all content is accessible, although we are aware of minor inconsistencies in how some screen readers handle complex features such as video transcripts.\n\nWhen navigating inside a page using the keyboard, the page content links do not scroll to the target content. However, focus is applied to the target content so screen readers will be directed to the appropriate content.\n\n## Limitations (Level AAA Only)\n\n**Focus Appearance (WCAG 2.4.13 - Level AAA):** While all focus indicators are visible (meeting Level AA requirements), browser default focus indicators may not consistently meet the enhanced AAA requirements for focus appearance (minimum 2px thickness and 3:1 contrast ratio) across all browsers and contexts.\n\n**Target Size (WCAG 2.5.5 - Level AAA):** Some interactive elements such as checkboxes, do not meet the enhanced AAA requirement of 44px × 44px minimum target size. All interactive elements meet the Level AA requirements for basic usability and are appropriately spaced to minimize accidental activation.\n\n## Feedback\n\nWe welcome your feedback on the accessibility of this website. If you experience any difficulty accessing content or have suggestions for improvement, please contact us at admin@morph.co.uk.\n\n## Assessment Information\n\n- **Evaluation method:** Self-assessment\n- **Statement last reviewed:** February 2026\n- **WCAG version:** 2.2\n- **Conformance level:** Level AA (conformant), Level AAA (partially conformant)",{"sectionLabel":176},"Conformance status","\u002Fpages\u002Faccessibility.en",{"title":163},"pages\u002Faccessibility.en","DjK6KEJOCn8oUVlBciFcg3zz1KED2P4NYtev9ad7Q4k",{"id":182,"title":33,"body":20,"description":20,"extension":5,"meta":183,"navigation":15,"path":217,"seo":218,"stem":219,"__hash__":220},"contentPages\u002Fpages\u002Fcontact.en.json",{"pageTitle":33,"pageMetadata":184,"page_content":185},{"htmlTitle":33,"htmlDesc":33},[186,195],{"type":56,"title":187,"text":188,"image":189,"sectionSettings":193},"# Contact us","If, at any time, you would like further information about this study you may email us or Dr Bernhard Frank who is the Chief Investigator for the FREMS-PDPN Study",{"url":190,"width":191,"height":192},"frems-header-image-2.svg",1100,720,{"sectionLabel":194},"Contact Us",{"type":92,"settings":196,"cards":199,"text":61,"sectionSettings":215},{"headerLevel":197,"headerFontSize":198,"maxCardsPerRow":94,"wholeClickable":28,"cardTheme":95,"alignCards":83,"alignCardContent":83},"2","4",[200,205,210],{"type":124,"title":201,"summary":202,"icon":203},"Email:","frems-pdpn@trials.bham.ac.uk",{"iconName":204,"iconSize":127},"content-mail",{"type":124,"title":206,"summary":207,"icon":208},"Email the Chief Investigator:","bernhard.frank@liv.ac.uk",{"iconName":209,"iconSize":127},"content-lab-flask",{"type":124,"title":211,"summary":212,"icon":213},"Call us:","+44 (0)121 415 9128",{"iconName":214,"iconSize":127},"content-tablet",{"sectionLabel":216},"Contact cards","\u002Fpages\u002Fcontact.en",{"title":33},"pages\u002Fcontact.en","kZJyXShJS3LlyZioL3GuqlFqe2dJacc1CnyJ6tli-78",{"id":222,"title":223,"body":20,"description":20,"extension":5,"meta":224,"navigation":15,"path":242,"seo":243,"stem":244,"__hash__":245},"contentPages\u002Fpages\u002Fcookies.en.json","Cookie Policy",{"pageTitle":225,"pageMetadata":226,"page_content":227},"Cookie policy",{"htmlTitle":223,"htmlDesc":223},[228,233,237],{"type":56,"title":229,"image":230,"sectionSettings":232},"# Cookie policy",{"url":231,"alt":61,"width":191,"height":192},"frems-header-image-3.svg",{"sectionLabel":223},{"type":173,"text":234,"sectionSettings":235},"## Website Cookies\n\nOur website uses necessary and non-necessary cookies. The necessary cookies are required for the website to function the right way, and they do not collect any of your personally identifiable data.\n\nThe non-necessary cookies used on our websites are used for understanding how the website is used so that we can provide you with a better user experience and help speed up your future interactions with our website.\n\n### Types of cookies we use\n\n**Necessary**: Some cookies are essential for you to be able to experience the full functionality of our site. They allow us to keep track of your progress through the site as well as enabling access to core functionality such as video playback. They do not collect or store any personal information.\n\n**Non-necessary**: These cookies store information like the number of visitors to the website, the number of unique visitors, which pages of the website have been visited, the source of the visit etc. These data help us understand and analyse how well the website performs and where it needs improvement.\n\n### Specific cookies we use\n\n#### Vimeo:\n\nPages that embed a Vimeo video load the Vimeo player when the page opens, so the cookies below may be set as soon as you open such a page — you do not have to press play. Pages with no video do not set them. These cookies do not track individuals. If you accept cookies, then choose to opt out later these cookies will not be deleted, but will stop tracking data after you have opted out.\n\n##### Cookie name: Player\n\n**Purpose**: Stores preferences for vimeo player controls (i.e. volume, stream quality, captions).\n\n**Necessary**: no\n\n**Expires in**: 1 year\n\n##### Cookie name: Vuid\n\n**Purpose**: Vimeo-generated ID used for generating analytics information for the video owner.\n\n**Necessary**: no\n\n**Expires in**: 2 years\n\n##### Cookie name: __cf_bm\u002F player_clearance\n\n**Purpose**: Cookies set by Vimeo's own Cloudflare protection to tell real visitors from bots.\n\n**Necessary**: yes\n\n**Expires in**: 30 minutes\u002F 7 days\n\n#### Our hosting provider (Cloudflare):\n\nThis website is served through Cloudflare, which sets the cookies below on our own domain to protect the site. They are set on **every** page, whether or not it contains a video, and are required for the site to be served securely.\n\n##### Cookie name: cf_clearance\n\n**Purpose**: Records that your browser passed Cloudflare's bot\u002Fsecurity check, so you are not re-challenged on every page.\n\n**Necessary**: yes\n\n**Expires in**: up to 1 year\n\n##### Cookie name: _cfuvid\n\n**Purpose**: Cloudflare cookie used to enforce rate limiting rules.\n\n**Necessary**: yes\n\n**Expires in**: current session only\n\n#### Cookie Name: _ga, _ga*\n\n**Purpose**: Used by Google Analytics to calculate visitor, session, campaign data and keep track of site usage for the site's analytics report. Stores information anonymously and assigns a randomly generated number to identify unique visitors.\n\n**Necessary**: no\n\n**Expires in**:  2 years\n\n## LocalStorage data\n\nWe also store data in your browser to keep track of your cookie preferences. This is stored in [LocalStorage](https:\u002F\u002Fen.wikipedia.org\u002Fwiki\u002FWeb_storage). This data is anonymous, persistent and necessary for the functioning of the site.\n\n### LocalStorage Key: GDPR:accepted\n\n**Purpose**: This localStorage property records whether you have accepted non-necessary cookies from this website. It is set only once you make a choice.\n\n**Necessary**: yes\n\n**Expires in**: permanent\n\n### Vimeo Local Storage\n\nVimeo uses browser local storage to remember video player preferences (such as volume and playback settings). These storage items are functional, are not used for advertising and store no identifiable information.\n\nExample keys may include\n\n* LOCAL_STORAGE_ID_VIMEO_PLAYER\n* sync_active\n\n**Necessary**: yes\n\n**Expires in**: variable\n\n## How can I control my cookie preferences?\n\nYou can edit your cookie preferences by clicking the link 'View and edit cookie settings' in the section 'What is my current cookie consent status?' below.\n\nIf you decide to 'Opt out' of non-necessary cookies, they may remain in your browser but will no longer be used to send data about your visit to the third party analytics service.\n\nIn addition to this, different browsers provide different methods to block and delete cookies used by websites. You can change the settings of your browser to block\u002Fdelete the cookies. To find out more out more on how to manage and delete cookies, visit [wikipedia.org](https:\u002F\u002Fen.wikipedia.org\u002Fwiki\u002FHTTP_cookie), [www.allaboutcookies.org.](http:\u002F\u002Fwww.allaboutcookies.org\u002F)\n\n## Contact Us\n\nIf you have any questions about the content of this page or problems with the website, please contact us at: admin@morph.co.uk",{"sectionLabel":236},"Website Cookies",{"type":78,"text":238,"componentName":239,"sectionSettings":240},"## What is my current cookie consent status?","CookiesOptInOut",{"sectionLabel":241},"View and Edit Cookie Settings","\u002Fpages\u002Fcookies.en",{"title":223},"pages\u002Fcookies.en","mz-p16bI18uTx_yeuMpKbOxS9PxDqJw8R16lTNoUxUM",{"id":247,"title":248,"body":20,"description":20,"extension":5,"meta":249,"navigation":15,"path":314,"seo":315,"stem":316,"__hash__":317},"contentPages\u002Fpages\u002Findex.en.json","Home page",{"pageTitle":250,"pageMetadata":251,"page_content":252},"The FREMS-PDPN Study",{"htmlTitle":250,"htmlDesc":250},[253,264,274,283],{"type":56,"title":254,"text":255,"image":256,"settings":260,"sectionSettings":261},"# The FREMS-PDPN Study","Evaluating 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)",{"url":257,"alt":61,"width":258,"height":259},"frems-header-image-6@2x.png",576,412,{"imgWidth":68},{"sectionLabel":262,"customClass":263,"theme":120},"The TRIAL Study","page_header_bg_2",{"type":265,"text":266,"video":267,"sectionSettings":272},"text_and_video","## The FREMS-PDPN Study Participant Information Animation\n\nDiabetes Mellitus (DM) is very common in the UK and globally and is a major health care challenge for the NHS. Diabetes UK announced that the number of people living with DM in the UK has more than doubled over the last 20 years.\n\nPainful Diabetes-related Peripheral Neuropathy (PDPN) is a serious complication affecting 20-26% of patients with DM.\n\nWith an increasing prevalence of DM, the prevalence and burden of PDPN is likely to increase further over the next decade, which will pose a major treatment and financial challenge.\n\n\n\nPlease watch our animation to find out more about the FREMS-PDPN study.",{"vimeoId":268,"videoTitle":269,"videoTranscript":270,"offlineVideo":61,"offline_video_thumbnail":271},"803426826\u002Fc37197382f","FREMS-PDPN Participant Information Animation","The FREMS-PDPN Study is looking at whether a nerve stimulation device can reduce pain from the nerve damage diabetes can cause. \n\nPeripheral Neuropathy happens because of nerve damage in the feet and legs. \n\nThis causes pain and discomfort that can badly affect sleep and quality of life. \n\nThe standard treatment for nerve pain is medication but it doesn’t work for everyone. \n\nIn this trial we are testing a treatment called FREMS. \n\nFREMS is like TENS treatment, which is already used in the NHS for pain relief. \n\nIt uses the same kind of device, with pads stuck to the skin giving electrical pulses that stimulate the nerve ends. \n\nEvidence suggests FREMS and TENS both work for pain in the short term. \n\nAnd both are safe. \n\nThe difference is that FREMS delivers a different, changing electrical pulse. \n\nWe hope this trial will tell us if FREMS helps nerve pain better and for longer than TENS. \n\nIf you would like to take part we will screen you to see if the study is suitable for you. \n\nFirst, you’ll need to give consent using an online form. \n\nWe will check your medical records. \n\nWe will ask you to complete a 7 day pain diary, sending us a daily score by text message. \n\nAfterwards, if you are eligible we will arrange your first visit in person. At this visit you can ask any questions. \n\nYou can then take your time to decide what you would like to do. \n\nIf you decide to join the study...you will be asked to sign another online consent form. \n\nAnswer some questions about your medical history. \u2028\n\nComplete questionnaires about your pain, sleep, mood, general health and wellbeing. \n\nAnd we will do some tests. \n\nIf your doctor thinks the study is right for you, you will be randomly allocated to your treatment. Half to FREMS, half to TENS. \n\nNeither you nor your doctor will know which you receive. \n\nThe rest of your care will continue as normal. \n\nThe treatment involves 10 sessions at hospital over two weeks, each about 40 minutes. \n\nThe electric pulse level is set by the nurse, based on how you feel. \n\nUsually the electrical stimulation can be felt as a kind of buzzing, but it shouldn’t be painful. \n\nWe will ask you to send us your daily pain scores for 6 months. \n\nIn the final treatment session we will ask you to complete the questionnaire again. \n\nThis will be repeated in visits at three and six months after the treatment, where we will also check your progress and carry out a final medical. \n\nJoining this study is completely voluntary and you can leave at any time.\u2028\n\nYour decision will not affect the standard of care you receive. \n\nThe study team will be happy to answer any questions you may have.","frems-logo.png",{"sectionLabel":273},"DRIFT Participant Information Animation",{"type":66,"settings":275,"title":276,"text":277,"image":278,"sectionSettings":281},{"imgWidth":68,"imgPosition":69},"## Background","PDPN affects a quarter of people with diabetes and 70% of sufferers have moderate-to-severe foot pain. This pain results in in sleep disruption, poor quality of life (QoL), unemployment and depression. The average health care cost for each patient with PDPN in the UK was estimated to be £2,511 per year, which increases with greater pain severity. The burden of PDPN is likely to increase as diabetes becomes more common.\n\nNICE guidance 173 recommended certain medications as initial treatments for PDPN. However, using these medications results in 50% reduction in pain in one third of patients at best. These medications also have multiple side effects such as nausea, sedation, dizziness, dry mouth, weight gain, falls, constipation and more.\n\nBeyond these drugs, there are no NICE recommended treatments. As a result, many patients receive opioids (43%), which has many unwanted side effects including addiction. Hence, there is a clear need to identify an effective, safe, well-tolerated, non-invasive intervention that is good value for money in those who fail to respond to NICE recommended treatments. This could reduce medications and opioid use & improve QoL.",{"url":279,"alt":61,"width":258,"height":280},"frems-content-image-1-1000w.png",377,{"sectionLabel":282},"Background",{"type":92,"settings":284,"cards":285,"sectionSettings":312},{"headerLevel":94,"headerFontSize":94,"maxCardsPerRow":94,"wholeClickable":15,"numberedCards":28,"cardTheme":120,"alignCards":96,"alignCardContent":96},[286,295,304],{"type":100,"image":287,"title":290,"summary":291,"links":292},{"url":288,"width":62,"height":289},"frems-card-image-1.svg",640,"Taking Part","Find out more about taking part in the study",[293],{"title":294,"url":24,"external":28,"target":28},"Go to 'Taking Part'",{"type":100,"image":296,"title":298,"summary":299,"links":300},{"url":297,"width":62,"height":289},"frems-card-image-5.svg","About the Study","Learn more about the study",[301],{"title":302,"url":303},"Got to 'About the Study'","\u002Fabout",{"type":100,"image":305,"title":194,"summary":307,"links":308},{"url":306,"width":62,"height":289},"frems-card-image-3.svg","Get in touch with the study team",[309],{"title":310,"url":311},"Get in touch","\u002Fcontact",{"sectionLabel":313},"Benefits of screening for type 1 diabetes:","\u002Fpages\u002Findex.en",{"title":248},"pages\u002Findex.en","mD4P5-eMSGgxX573Chcovv1k9RWRWdf0jFn7LqED6aA",{"id":319,"title":320,"body":20,"description":20,"extension":5,"meta":321,"navigation":15,"path":334,"seo":335,"stem":336,"__hash__":337},"contentPages\u002Fpages\u002Fprivacy.en.json","Privacy policy",{"pageTitle":322,"pageMetadata":323,"page_content":324},"Privacy page",{"htmlTitle":320,"htmlDesc":320},[325,330],{"type":56,"title":326,"image":327,"sectionSettings":329},"# Privacy policy",{"url":328,"alt":61,"width":191,"height":192},"frems-header-image-11.svg",{"sectionLabel":320},{"type":173,"text":331,"sectionSettings":332},"This website has been designed and developed by Morph Media Limited specifically for this clinical trial. We understand that your privacy is important to you and that you care about how your personal data is used. We respect and value the privacy of all of our customers and suppliers’ data and will only collect and use personal data in ways that are described here, and in a way that is consistent with our obligations and your rights under the law.\n\n## 1. Information about us\n\nMorph Media Limited, a limited company (company number 13801210).\n\nMain trading address: 8 New Shambles, Kendal, LA9 4TS\n\nVAT Reg: 400 693 620\n\nData Protection Officer: Matthew Brook\n\nEmail address: info@morph.co.uk\n\nTelephone number: 01524 88 42 88\n\nPostal Address: 8 New Shambles, Kendal, LA9 4TS\n\n## 2. What does this policy cover?\n\nThis Privacy Policy relates specifically to this website only and explains how we use your personal data on the site: how it is collected, how it is held, and how it is processed. It also explains your rights under the law relating to your personal data.\n\n## 3. What is personal data?\n\nPersonal data is defined by the General Data Protection Regulation (EU Regulation 2016\u002F679) (the “GDPR”) as ‘any information relating to an identifiable person who can be directly or indirectly identified in particular by reference to an identifier’. Personal data is, in simpler terms, any information about you that enables you to be identified. Personal data covers obvious information such as your name and contact details, but it also covers less obvious information such as identification numbers, electronic location data, and other online identifiers. The personal data that we use is set out in Part 5, below.\n\n## 4. What are your rights?\n\nUnder the GDPR, you have the following rights, which we will always work to uphold:\n\n1. The right to be informed about our collection and use of your personal data. This Privacy Policy should tell you everything you need to know, but you can always contact us to find out more or to ask any questions using the details in Part 11.\n2. The right to access the personal data we hold about you. Part 10 will tell you how to do this.\n3. The right to have your personal data rectified if any of your personal data held by us is inaccurate or incomplete. Please contact us using the details in Part 11 to find out more.\n4. The right to be forgotten, i.e. the right to ask us to delete or otherwise dispose of any of your personal data that we have. Please contact us using the details in Part 11 to find out more.\n5. The right to restrict (i.e. prevent) the processing of your personal data.\n6. The right to object to us using your personal data for a particular purpose or purposes.\n7. The right to data portability. This means that, if you have provided personal data to us directly, we are using it with your consent or for the performance of a contract, and that data is processed using automated means, you can ask us for a copy of that personal data to re-use with another service or business in many cases.\n8. Rights relating to automated decision-making and profiling. We do not use your personal data in this way.\n\nFor more information about our use of your personal data or exercising your rights as outlined above, please contact us using the details provided in Part 11.\n\nFurther information about your rights can also be obtained from the Information Commissioner’s Office or your local Citizens Advice Bureau.\n\nIf you have any cause for complaint about our use of your personal data, you have the right to lodge a complaint with the Information Commissioner’s Office.\n\n## 5. What personal data do we collect when you visit this website?\n\nYou may visit the Site without telling us who you are or revealing any personally identifiable information about you. \n\nThe website is hosted by Cloudflare using their Workers service. Cloudflare maintains log data about events on its network. Some of this log data will include information about visitors to and\u002For authorized users of a customer’s domains, networks, websites, application programming interfaces (“APIs”), or applications. This metadata contains extremely limited personal data, most often in the form of IP addresses. Cloudflare process this type of information on behalf of its  customers in its main data centers in the U.S. and Europe for a limited period of time.\n\nFor full details of Cloudflare's approach to privacy and data protection is available using the following link, although please bear in mind that these are wide-ranging documents with many documents not directly relevant to the service we use: \u003Ca href=\"https:\u002F\u002Fwww.cloudflare.com\u002Fen-gb\u002Ftrust-hub\u002Fprivacy-and-data-protection\u002F\" target=\"_blank\">https:\u002F\u002Fwww.cloudflare.com\u002Fen-gb\u002Ftrust-hub\u002Fprivacy-and-data-protection\u002F\u003C\u002Fa>\n\nIf you use the Contact Form on this website, then a service called smtp2go will be used to pass your email on to the trial team. This will involve your email contents being logged with smtp2go for 5 days on a server within the EU, providing a temporary record in the event that we need to troubleshoot any issues.\n\n**Please note**: this Privacy policy does not cover handling of email content by the intended recipient(s).\n\n[Cookie Policy](\u002Fcookie-policy)\n\n## 6. How do we use your personal data?\n\nUnder the GDPR, we must always have a lawful basis for using personal data. This may be because the data is necessary for our performance of a contract with you, because you have consented to our use of your personal data, or because it is in our legitimate business interests to use it. Your personal data may be used for one of the following purposes:\n\n* IP addresses are required by Cloudflare to troubleshoot a number of issues, such as connectivity issues, tracking down specific HTTP responses, tracking DDoS attacks.\n\n## 7. How long will we keep your personal data?\n\nCloudflare processes metadata, including IP addresses, for a limited period of time. Where the technical logs described in Part 10 are kept, they are held for no more than 7 days and are then deleted automatically.\n\n## 8. How and where do we store or transfer your personal data?\n\nWe may store or transfer some or all of your personal data in countries that are not part of the European Economic Area (the “EEA” consists of all EU member states, plus Norway, Iceland, and Liechtenstein). These are known as “third countries” and may not have data protection laws that are as strong as those in the UK and\u002For the EEA. Morph's relationship with Cloudflare with regard to personal data is covered by Cloudflare's standard Data Processing Addendum \n\u003Ca href=\"https:\u002F\u002Fwww.cloudflare.com\u002Fen-gb\u002Fcloudflare-customer-dpa\u002F\" target=\"_blank\">https:\u002F\u002Fwww.cloudflare.com\u002Fen-gb\u002Fcloudflare-customer-dpa\u002F\u003C\u002Fa> which ensures that your personal data is treated just as safely and securely as it would be within the UK and under the GDPR.\n\n## 9. Do we share your personal data?\n\nNo.\n\n## 10. How can I access my personal data?\n\nOur hosting provider may keep short-lived technical logs of requests made to this website, and these can include IP addresses. Where such logs are kept they are held for no more than 7 days and are then deleted automatically. Morph staff can view them in order to diagnose faults with the site, but we do not use them to identify individual visitors and we do not link them to any other information we hold.\n\n## 11. How do I contact you?\n\nTo contact us about anything to do with your personal data and data protection, including to make a subject access request, please use the following details (for the attention of Matthew Brook):\n\nEmail address: info@morph.co.uk\n\nTelephone number: 01524 88 42 88\n\nPostal Address: 8 New Shambles, Kendal, LA9 4TS\n\n## 12. Changes to this Privacy Policy\n\nWe may change this Privacy Policy from time to time. This may be necessary, for example, if the law changes, or if we change our business in a way that affects personal data protection. Any changes will be made available on this website.",{"sectionLabel":333},"Content","\u002Fpages\u002Fprivacy.en",{"title":320},"pages\u002Fprivacy.en","mQGd87ATjL56EPNY8KBXBRESUWpjOIIkSrO608RzKxI",{"id":339,"title":30,"body":20,"description":20,"extension":5,"meta":340,"navigation":15,"path":357,"seo":358,"stem":359,"__hash__":360},"contentPages\u002Fpages\u002Fresources.en.json",{"pageTitle":30,"pageMetadata":341,"page_content":342},{"htmlTitle":30,"htmlDesc":30},[343,349],{"type":56,"title":344,"text":345,"image":346,"sectionSettings":348},"# Resources","This page provides access to useful documents relating to the FREMS-PDPN study",{"url":347,"width":62,"height":63},"frems-header-image-14.svg",{},{"type":66,"settings":350,"title":61,"text":352,"image":353,"sectionSettings":356},{"imgWidth":68,"imgPosition":351},"bottom","## FREMS-PDPN Participant Information Sheet\n\nClick on the link below to download.\n\n\u003Ca href=\"https:\u002F\u002Ffrems.digitrial.com\u002Fimg\u002Ffrems-pdpn-pis-v7.0-03-jun-2025.pdf\" download=\"FREMS-PDPN-PIS_V7.0_03-JUN-2025.pdf\">FREMS-PDPN-PIS_V7.0_03-JUN-2025.pdf\u003C\u002Fa>",{"url":354,"width":62,"height":355},"frems-content-image-27-1000w.png",909,{},"\u002Fpages\u002Fresources.en",{"title":30},"pages\u002Fresources.en","q24YndZQd-WnzPmpadtX6QMrNV_oL2PL75f1tHeSSQo",{"id":362,"title":23,"body":20,"description":20,"extension":5,"meta":363,"navigation":15,"path":390,"seo":391,"stem":392,"__hash__":393},"contentPages\u002Fpages\u002Ftaking-part.en.json",{"pageTitle":23,"pageMetadata":364,"page_content":365},{"htmlTitle":23,"htmlDesc":23},[366,372,379],{"type":56,"title":367,"text":368,"image":369,"sectionSettings":371},"# Taking part","This page explains the FREMS-PDPN Study for people who might be interested in joining",{"url":370,"width":62,"height":63},"frems-header-image-5.svg",{"theme":120,"sectionLabel":61},{"type":66,"settings":373,"title":374,"text":375,"image":376,"sectionSettings":378},{"imgWidth":68,"imgPosition":351},"## General information","We are inviting 356 adults with PDPN to take part in this study.\n\nThe FREMS-PDPN Study is looking at whether a nerve stimulation device can reduce pain from the nerve damage caused by diabetes.\n\nYou will receive a treatment chosen by chance. The treatments are FREMS (Frequency Rhythmic Electrical Modulated System) or TENS (Transcutaneous Electrical Nerve Stimulation). \n\nBoth FREMS and TENS give electrical pulses delivered through stickers on the skin. The nature of these pulses is different between FREMS and TENS, resulting in different biological effects on pain and different responses (short term pain reductions for TENS, usually days, and 3-4 months for FREMS).",{"url":377,"width":62,"height":74},"frems-content-image-8-1000w.png",{},{"type":66,"settings":380,"text":381,"title":382,"image":383,"links":385,"sectionSettings":389},{"imgWidth":68,"imgPosition":351},"If you are considering taking part in the FREMS-PDPN Study, please follow the link below to open the FREMS-PDPN Participant Information Tool. Here you can view the key information needed to decide whether to take part.","## FREMS-PDPN Participant Information",{"url":384,"width":62,"height":74},"frems-content-image-25-1000w.png",[386],{"title":387,"url":388,"target":15},"FREMS Participant Information","https:\u002F\u002Ffrems-info.digitrial.com",{},"\u002Fpages\u002Ftaking-part.en",{"title":23},"pages\u002Ftaking-part.en","Z-OePeu9y-6lldJfrGHtzVudNkmmO07Y7X_919nyeys",[],1790615125457]