[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605490":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":50,"responsibleParty":75,"collaborators":44,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":44,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":100,"overallStatus":109,"whyStopped":44,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Universitas Harapan Bangsa","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Smart Bandage + Standard Wound Care","EXPERIMENTAL","Participants in this arm will receive a smart bandage with integrated sensors (pH, temperature, and moisture) connected to a mobile telemonitoring platform. Wound data will be transmitted securely to wound care nurses for review. In addition, patients will receive standard wound care including compression therapy, conventional dressings, sharp debridement when indicated, and patient education.",[13],"Device: Smart Bandage with Telemonitoring",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Bandage + Standard Wound Care","ACTIVE_COMPARATOR","Participants will receive standard wound care (compression therapy, debridement when indicated, and patient education) plus a conventional bandage without digital monitoring features. This represents usual care according to international guidelines",[19],"Device: Conventional Bandage",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Smart Bandage with Telemonitoring","A smart wound bandage with integrated sensors (pH, temperature, moisture) connected to a mobile telemonitoring platform. Wound data are transmitted securely to a mobile application monitored by wound care nurses. The device is applied in addition to standard wound care (compression therapy, conventional dressing, debridement when indicated, and patient education).",[9],[27],"Smart wound bandage, Digital wound monitoring bandage",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Conventional Bandage","A conventional wound bandage without digital monitoring features. It is applied in addition to standard wound care (compression therapy, conventional dressing, debridement when indicated, and patient education). This represents usual care according to international guidelines.",[15],[33],"Standard wound dressing, Non-digital bandage",[35],{"name":36,"affiliation":37,"role":38},"Septian Mixrova Sebayang, MSN","Universitas Harapan Bangsa - Clinic Podiatry Care, Purwokerto","PRINCIPAL_INVESTIGATOR",[40,46],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Indah Susanti, MSN","CONTACT","+6285869181749",null,"indahsusanti@uhb.ac.id",{"name":47,"role":42,"phone":48,"phoneExt":44,"email":49},"Diaz Ibrahim, MSN","081391164755","diaibrahim@podiatricare.my.id",[51],{"facility":52,"status":44,"city":53,"state":54,"zip":55,"country":54,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Podiatry Clinic","Banyumas","Indonesia","64118","ID",{"type":58,"coordinates":59},"Point",[60,61],109.29417,-7.51417,{"lat":61,"lon":60},[64,68,72],{"name":65,"role":42,"phone":66,"phoneExt":44,"email":67},"Asmat Burhan, Master of Nursing Science","085746157782","asmatburhan1@gmail.com",{"name":69,"role":42,"phone":70,"phoneExt":44,"email":71},"Indah Susanti, Master of Science Nursing","085869181749","indahnoni138@gmail.com",{"name":73,"role":74,"phone":44,"phoneExt":44,"email":44},"Septian M Sebayang, Master of Science Nursing","SUB_INVESTIGATOR",{"type":76,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"SPONSOR_INVESTIGATOR","Asmat Burhan","Lecturer\u002FResearcher, Faculty of Health Sciences, Universitas Harapan Bangsa","100605490","smart-bandage-with-telemonitoring-vs-standard-care-for-venous-leg-ulcer-randomized-trial-100605490",false,"NCT07163195","Smart Bandage With Telemonitoring vs Standard Care for Venous Leg Ulcer: Randomized Trial","Smart Bandage With App-Based Telemonitoring vs Standard Care for Venous Leg Ulcer: Randomized Trial","SMART-VLU","Inclusion Criteria:\n\n* Adults aged 18 to 65 years\n* Clinically diagnosed venous leg ulcer persisting for more than 3 weeks\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Age \\>65 years (elderly patients excluded)\n* Acute or emergency wounds\n* Mixed etiology ulcers with significant arterial involvement\n* Severe comorbid illness such as end-stage renal failure or active malignancy\n* Cognitive impairment preventing informed consent\n* Allergy to dressing materials","ALL","18 Years","65 Years",{"count":91,"type":92},110,"ESTIMATED","INTERVENTIONAL",[95],"NA","Venous leg ulcers (VLUs) are chronic wounds that are often slow to heal and can greatly affect patients' daily lives. This study will evaluate a new \"smart bandage\" that can monitor wound conditions such as pH, temperature, and moisture, and transmit this information to a mobile app for nurses to review. Care can then be adjusted in real time.\n\nThe purpose of this randomized controlled trial is to compare smart bandage plus standard wound care with standard wound care alone. We will assess whether the smart bandage improves healing rates within 12 weeks, shortens time to healing, reduces infection, and improves quality of life in patients with VLUs. About 110 adult participants with VLUs will be enrolled at Clinic Podiatry Care, Purwokerto, Indonesia.",[98,99],"Venous Leg Ulcer (VLU)","Chronic Wound",[101,99,102,103,104,105,106,107,108,54],"Venous Leg Ulcer","Smart Bandage","Telemonitoring","Digital Health","Mobile Application","Wound Care","Wound Healing","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-06-03",{"date":112,"type":113},"2026-06-04","ACTUAL",{"date":115,"type":92},"2026-07-26",{"date":117,"type":92},"2027-01-27",{"name":77,"class":6},1]