[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"painful-diabetic-neuropathy-pdn\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:painful-diabetic-neuropathy-pdn":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100632129","the-treatment-of-painful-diabetic-neuropathy-with-diet-100632129",false,"NCT07509671","The Treatment of Painful Diabetic Neuropathy With Diet","The Treatment of Painful Diabetic Neuropathy With Diet, a Randomized-controlled Trial","Inclusion Criteria:\n\n* Definitive diagnosis of type II diabetes mellitus (HgA1c ≥ 6.5) or pre-diabetes (HgA1c 5.7-6.4)\n* objective documentation of peripheral neuropathy on EMG\u002FNCS testing defined as a sural-to-radial amplitude ratio of 0.21 or less\n* presence of painful neuropathy in addition to decreased sensation\n* with pain rated ≥4\u002F10 on a 0-10 numerical rating scale (NRS)\n* age 18 years or older\n* ability to provide informed consent\n* ability to attend follow-up visits.\n\nExclusion Criteria:\n\n* Potential causes of neuropathy other than type II diabetes mellitus (as listed below)\n* type I diabetes\n* vitamin B12 deficiency\n* folate deficiency\n* thyroid dysfunction,\n* other nutritional deficiencies\n* autoimmune disorders\n* inflammatory disorders\n* HIV\u002FAIDS\n* exposure to metals or toxins\n* multiple myeloma,\n* moderate to severe lumbar stenosis with neurogenic claudication","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"NA","The purpose of this clinical trial is to determine whether targeted nutritional changes can improve symptoms of painful diabetic neuropathy. Impaired blood flow to peripheral nerves-resulting in reduced oxygen delivery and subsequent nerve injury-is a well-established contributor to neuropathy. Prior studies have shown that a whole-food, plant-based diet without added oils can improve or even reverse arterial disease, suggesting a potential mechanism for enhancing nerve perfusion and function.\n\nThis study is a randomized controlled trial comparing a whole-food, plant-based diet with standard pharmacologic management for painful diabetic neuropathy.",[26,27,28],"Painful Diabetic Neuropathy (PDN)","Peripheral Neuropathy With Type 2 Diabetes","Vegan Diet",[30,31,32,33,34,35],"painful","diabetic","neuropathy","peripheral neuropathy","diabetes","diabetes type 2","RECRUITING","2026-04-27",{"date":39,"type":40},"2026-04-30","ACTUAL",{"date":42,"type":40},"2024-04-23",{"date":44,"type":20},"2028-02-28",{"name":46,"class":47},"AdventHealth","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":60,"conditions":61,"keywords":67,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":48},"100607937","thai-painpredict-validation-study-100607937","NCT07195045","Thai PainPREDICT Validation Study","Thai Version of PainPREDICT: Translation, Validation, and Mobile Application Development for Screening Painful Diabetic Neuropathy in Diabetes Patients","PainPREDICT-Th","Inclusion Criteria:\n\n* Adults aged 18 years or older.\n* Diagnosed with type 1 diabetes mellitus or type 2 diabetes mellitus.\n* Able to communicate in Thai.\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Presence of neuropathy due to other causes (e.g., alcohol, chemotherapy, HIV, other systemic diseases).\n* Significant cognitive impairment or neurological conditions that prevent comprehension of the questionnaire.\n* Severe psychiatric illness that interferes with study participation.",{"count":58,"type":20},277,[23],"Painful diabetic neuropathy (PDN) is one of the most common and disabling complications of diabetes mellitus, substantially affecting quality of life, daily functioning, and health system burden. Early identification of PDN is crucial for timely treatment, prevention of complications such as foot ulcers and amputations, and for reducing healthcare costs. However, in Thailand there are limited culturally adapted and validated tools for screening PDN. PainPREDICT is an internationally validated questionnaire designed to characterize neuropathic pain profiles, but its adaptation for Thai patients has not yet been undertaken. In parallel, the use of mobile health technologies (mHealth) has the potential to expand access to screening and monitoring of chronic conditions, particularly in resource-limited settings.",[26,62,63,64,65,66],"Diabetic Neuropathy, Distal Symmetric Polyneuropathy (Manifestation)","Type 1 Diabetes Mellitus (T1DM)","Type 2 Diabetes Mellitus (T2DM)","Neuropathic Pain","Diabetes Complications",[68,69,70,71,72,73,74,75,76,77,66,78],"PainPREDICT","Painful Diabetic Neuropathy","Diabetic Neuropathy","Neuropathic Pain Questionnaire","Mobile Health (mHealth)","Questionnaire Validation","Screening Tool","Thai Population","Cross-Cultural Adaptation","Digital Health Application","Neuropathy Screening","2025-09-29",{"date":81,"type":40},"2025-10-03",{"date":83,"type":40},"2025-08-28",{"date":85,"type":20},"2027-12-31",{"name":87,"class":47},"Chulalongkorn University"]