[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601392":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":44,"centralContacts":48,"locations":58,"responsibleParty":80,"collaborators":33,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":33,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":33,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":60,"whyStopped":33,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"University of Lahore","OTHER",[8,13,19,24],{"label":9,"type":6,"description":10,"interventionNames":11},"Standard Care Only","Participants will receive standard care for diabetic foot ulcers.",[12],"Other: Standard Care Only",{"label":14,"type":15,"description":16,"interventionNames":17},"Custom Insole + Standard Care","EXPERIMENTAL","Participants will receive a custom insole along with standard care.",[18],"Other: Custom Insole + Standard Care",{"label":20,"type":15,"description":21,"interventionNames":22},"TENS + Custom Insole + Standard Care","Participants will receive TENS therapy, a custom insole, and standard care.",[23],"Other: TENS + Custom Insole + Standard Care",{"label":25,"type":15,"description":26,"interventionNames":27},"TENS + Standard Care","Participants will receive transcutaneous electrical nerve stimulation (TENS) in addition to standard care.",[28],"Other: TENS plus Standard Care",[30,34,38,41],{"type":6,"name":9,"description":31,"armGroupLabels":32,"otherNames":33},"Standard care includes routine wound debridement, moist wound dressings infection control, glycemic management, vascular assessment, and patient education in line with international DFU management guidelines.",[9],null,{"type":6,"name":35,"description":36,"armGroupLabels":37,"otherNames":33},"TENS plus Standard Care","This experimental group will receive the same intervention plus Transcutaneous Electrical Nerve Stimulation (TENS) in burst mode (1-4 Hz at 100 Hz) applied around the wound site for 30 minutes, along with standard care.",[25],{"type":6,"name":14,"description":39,"armGroupLabels":40,"otherNames":33},"The experimental group will receive customised polyethene foam insoles with a Poron top layer along with standard care.",[14],{"type":6,"name":20,"description":42,"armGroupLabels":43,"otherNames":33},"Participants in this group will receive a combination of transcutaneous electrical nerve stimulation (TENS), custom-made insole therapy, and standard care for diabetic foot ulcers (DFUs).",[20],[45],{"name":46,"affiliation":5,"role":47},"Prof. Dr. Ashfaq Ahmed, PhD Physiotherapy","STUDY_DIRECTOR",[49,54],{"name":50,"role":51,"phone":52,"phoneExt":33,"email":53},"Ayesha Jamil, M.Phil Physiotherapy","CONTACT","+92 324 4481031","ayeshabutt031@gmail.com",{"name":55,"role":51,"phone":56,"phoneExt":33,"email":57},"Maryam Shabbir, PhD Rehabilitation","+92 300 4391550","maryam.shabbir@uipt.uol.edu.pk",[59],{"facility":5,"status":60,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"RECRUITING","Lahore","Punjab Province","54000","Pakistan","PK",{"type":67,"coordinates":68},"Point",[69,70],74.35071,31.558,{"lat":70,"lon":69},[73,74,77],{"name":50,"role":51,"phone":52,"phoneExt":33,"email":53},{"name":55,"role":51,"phone":33,"phoneExt":75,"email":76},"+923004391550","maryam.shabbir@uipt.uol.edu",{"name":78,"role":79,"phone":33,"phoneExt":33,"email":33},"Ayesha Jamil, M. Phil Physiotherapy","PRINCIPAL_INVESTIGATOR",{"type":79,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Ayesha Jamil","Assistant Professor","100601392","custom-insole-with-transcutaneous-electrical-nerve-stimulation-on-clinical-outcomes-of-diabetic-foot-ulcers-100601392",false,"NCT07109895","Custom Insole With Transcutaneous Electrical Nerve Stimulation on Clinical Outcomes of Diabetic Foot Ulcers","Effects of a Polyethene-Poron Custom Insole Combined With Transcutaneous Electrical Nerve Stimulation on Clinical Outcomes in Diabetic Foot Ulcers","Inclusion Criteria:\n\n1. 18-60 years old with type 1 and 2 diabetes\n2. Both Males and Females\n3. Having Foot ulcers in Grade 1 and Grade 2 according to the Wagner Classification\n\nExclusion Criteria:\n\n1. History of amputation (proximal to the trans-metatarsal joint)\n2. Active or inactive Charcot foot\n3. Non-constructible peripheral vascular disease secondary to arteriosclerosis (AS)\n4. Leg length discrepancy\n5. The presence of any allergic condition of the skin,\n6. Chronic consumption of opioids,\n7. Use of a cardiac pacemaker,\n8. Major bone operation,\n9. Neurological illness, such as a vestibular disorder with a history of dizziness 10. Mental disorders, which might interfere with the assessment process\n\n11\\. Dementia or impaired cognitive function","ALL","18 Years","60 Years",{"count":94,"type":95},40,"ESTIMATED","INTERVENTIONAL",[98],"NA","Diabetic foot ulcers (DFUs) are one of the serious complications of diabetes, typically resulting from neuropathy or peripheral arterial disease, and can often lead to amputation. It affects approximately 6.3% of people with diabetes globally. In Pakistan, the overall prevalence of DFUs is 16.83%, with a slightly higher rate in females. Diabetic foot ulcers are the main reason for lower extremity amputation (LEA) with non-traumatic origin, hospitalization, healthcare costs, and mortality.",[101],"Diabetic Foot Ulcer",[103,101,104,105,106,107,108,109,110,111],"Functional Disability","Transcutaneous Electrical Nerve Stimulation","Customized Insole","Pain","Dynamic Balance","Risk of Fall","Wound Size","Wound Depth","Diabetes","2025-08-11",{"date":114,"type":115},"2025-08-14","ACTUAL",{"date":117,"type":115},"2025-08-10",{"date":119,"type":95},"2026-01-30",{"name":5,"class":6},1]