[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100522548":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":27,"centralContacts":32,"locations":40,"responsibleParty":56,"collaborators":60,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":23,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":43,"whyStopped":23,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Royal Free Hospital NHS Foundation Trust","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Path Active","Participants randomised to use the device",[12],"Device: Path Active",{"label":14,"type":6,"description":15,"interventionNames":16},"Control Group","Participants randomised to care as usual",[17],"Other: Control Group",[19,24],{"type":20,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"DEVICE","Participant use of Path Active insoles, mobile phone app and clinician's dashboard (where pressure and temperature changes can be reviewed by a clinician). All participants will complete a patient questionnaire relating to use of the device and EuroQol - EQ5D at the beginning and end of the study.",[9],null,{"type":6,"name":14,"description":25,"armGroupLabels":26,"otherNames":23},"Control Group will receive care as usual.",[14],[28],{"name":29,"affiliation":30,"role":31},"Richard Leigh, BSc","Royal Free London NHS Foundation Trust","STUDY_CHAIR",[33,37],{"name":29,"role":34,"phone":35,"phoneExt":23,"email":36},"CONTACT","+44208302749","richardleigh1@nhs.net",{"name":38,"role":34,"phone":23,"phoneExt":23,"email":39},"Lise Pape, MSc","lise@walkwithpath.com",[41],{"facility":42,"status":43,"city":44,"state":23,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Royal Free Hospital","RECRUITING","London","NW3 2QE","United Kingdom","UK",{"type":49,"coordinates":50},"Point",[51,52],-0.12574,51.50853,{"lat":52,"lon":51},[55],{"name":29,"role":34,"phone":35,"phoneExt":23,"email":36},{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Richard Leigh","Chief Investigator",[61],{"name":62,"class":63},"Walk With Path","INDUSTRY","100522548","path-active-multicentre-randomised-controlled-trial-previous-pilot-path-active-safety-and-tolerability-study-100522548",false,"NCT06084052","Path Active Multicentre Randomised Controlled Trial (Previous Pilot: Path Active; Safety and Tolerability Study)","PAMRCT","Inclusion Criteria:\n\n* • Participant able to give informed consent.\n* Age \\>18 at the time of consent.\n* Diagnosis of Type 1 or Type 2 Diabetes.\n* Both Feet Intact (no ulceration).\n* Participant understands and is willing to participate and can comply with the follow-up regime.\n* Participant diabetes foot Risk Stratification as 'High Risk' as in Frame (2021) Scotland\u002FEngland https:\u002F\u002Fwww.diabetesframe.org\u002F\n* Ability to walk independently for \\> 100 metres i.e without use of wheelchair, walking stick or personal assistance.\n* Participant able and willing to wear suitable footwear.\n* Must own a mobile phone and be willing to upload WWP app.\n\nExclusion Criteria:\n\n* Either foot has less than 2 arterial vessel run-off on Doppler.\n* Poor visual acuity ie registered blind, unless supported by carer.\n* Current participation in another clinical investigation of a medical device or a drug; or participation in such a study within 30 days prior to study enrolment.\n* Body Mass Index (BMI) \\>40.\n* Participant has bespoke contact insoles and footwear.\n* Participant is unable to use 'medium' or 'large' insoles due to foot size eg. small or extra large feet.\n* Participant has a pacemaker.\n* Participant is pregnant.","ALL","18 Years","100 Years",{"count":75,"type":76},120,"ESTIMATED","INTERVENTIONAL",[79],"NA","Path Active™ comprises a pair of monitoring insoles which measure parameters associated with foot ulceration in diabetes: temperature and pressure. The insoles are linked via an app to the wearer's mobile phone and also to a clinical dashboard so that both wearer and clinician are alerted to early signs of skin damage on the foot so that immediate preventive action can be taken. The study is a multisite randomised controlled trial which will evaluate the effectiveness of Path Active™ in 60 people with diabetes who are at 'high risk' of foot ulceration, compared with 60 people who receive their usual podiatry foot checks over a period of 12 weeks.",[82],"Diabetic Foot",[84],"Foot Ulcer Prevention","2025-04-11",{"date":87,"type":88},"2025-04-15","ACTUAL",{"date":90,"type":88},"2024-04-02",{"date":92,"type":76},"2026-03-31",{"name":5,"class":6},1]