[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetic-polyneuropathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetic-polyneuropathy":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,44,77,99,140,161,197,226,254,292,320,341],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100621336","pulp-sensibility-and-masseter-inhibitory-reflex-in-diabetic-polyneuropathy-100621336",false,"NCT07369297","PULP SENSIBILITY AND MASSETER INHIBITORY REFLEX IN DIABETIC POLYNEUROPATHY","EVALUATION OF ELECTRICAL AND THERMAL PULP SENSORY THRESHOLDS AND MASSETER INHIBITORY REFLEX RESPONSES IN PATIENTS WITH DIABETIC POLYNEUROPATHY","Inclusion Criteria:\n\nAbility to understand the study procedures and provide written informed consent.\n\nFor diabetic polyneuropathy groups:\n\n* Diagnosis of diabetic polyneuropathy confirmed by a neurologist\n* Neuropathy severity (mild or severe) determined by nerve conduction studies\n\nFor healthy control group:\n\n* No history of diabetes mellitus\n* No history of peripheral neuropathy or neurological disease\n\nPresence of at least one maxillary central incisor suitable for testing, defined as:\n\n* No previous root canal treatment\n* No extensive caries\n* No clinical or radiographic signs of periapical pathology\n* No periodontal disease affecting the selected tooth\n\nExclusion Criteria:\n\n* History of chemotherapy, head and neck radiotherapy, or systemic conditions known to affect peripheral nerve function (other than diabetic polyneuropathy in the patient groups)\n* Presence of acute or chronic orofacial pain disorders\n* Use of medications within the last 24 hours that may affect sensory perception or nerve conduction (e.g., analgesics, sedatives, neuroactive drugs)\n* History of trauma to the maxillary central incisor or surrounding tissues\n* Extensive restorations, fractures, caries, or periodontal pathology involving the selected tooth\n* Pregnancy or breastfeeding\n* Inability to tolerate study procedures or refusal to continue participation at any point",true,"ALL","25 Years","65 Years",{"count":21,"type":22},108,"ESTIMATED","OBSERVATIONAL","Accurate evaluation of dental pulp health is essential to avoid unnecessary endodontic treatments. In routine dental practice, pulp sensibility is commonly assessed using electric pulp testing and thermal (cold) testing. However, these tests depend on patient perception and may be influenced by various factors such as systemic diseases, nerve damage, anxiety, trauma, or medication use.\n\nDiabetic polyneuropathy is a common complication of diabetes mellitus and may alter peripheral nerve function, potentially affecting dental pulp sensibility test responses. This clinical study aims to evaluate how the severity of diabetic polyneuropathy influences dental pulp sensibility responses and masseter inhibitory reflex (MIR) parameters. The MIR is an objective neurophysiological reflex that allows quantitative assessment of trigeminal nerve function.\n\nIn this study, individuals with mild diabetic polyneuropathy, severe diabetic polyneuropathy, and healthy controls will be evaluated. All participants will undergo electric pulp testing, cold testing, and MIR measurements using standardized protocols.\n\nThe primary hypothesis of this study is that increasing severity of diabetic polyneuropathy leads to reduced dental pulp sensibility responses and altered MIR parameters compared to healthy individuals. It is further hypothesized that conventional pulp sensibility tests may produce false-negative results in patients with advanced neuropathy.\n\nThe findings of this study are expected to contribute to more accurate endodontic diagnosis and improved understanding of orofacial neurophysiological changes in diabetic patients.",[26,27],"Diabetic Polyneuropathy","Healthy Individuals (Controls)",[26,29,30,31],"Electrical Pulp Test","Cold Test","Masseter Inhibitory Reflex","NOT_YET_RECRUITING","2026-04-02",{"date":35,"type":36},"2026-04-03","ACTUAL",{"date":38,"type":22},"2026-04-15",{"date":40,"type":22},"2027-01-15",{"name":42,"class":43},"Bezmialem Vakif University","OTHER",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":60,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100592959","phase-2-peripheral-magnetic-stimulation-with-balance-training-to-decrease-fall-risks-in-diabetic-polyneuropathy-100592959","NCT07000214","Peripheral Magnetic Stimulation With Balance Training to Decrease Fall Risks in Diabetic Polyneuropathy","Peripheral Magnetic Stimulation With Balance Training to Decrease Fall Risks in Older Patients With Diabetic Polyneuropathy","Inclusion Criteria:\n\n* Diabetes mellitus type 2 with any symptoms of distal polyneuropathy, including numbness, paresthesia, dysesthesia, or lower leg weakness.\n* Abnormal 10g monofilament test.\n* Abnormal one-leg stance test (OLST) with eyes open.\n\nExclusion Criteria:\n\n* Chronic foot ulceration.\n* Severe leg or foot pain not controllable with medications or other interventions.\n* Significant foot deformity, including severe pes cavus, severe claw toe, or toe amputation.\n* Body mass index (BMI) over 35 kg\u002Fm².\n* Visual acuity less than 20\u002F100 after correction with glasses or contact lenses.\n* Postural instability or coordination disorders resulting from musculoskeletal, vestibular, or central nervous system conditions.\n* Symptoms such as confusion, drowsiness, dizziness, or a high risk of falls due to any disease or recent medication changes within a two-week period.\n* Presence of cardiac pacemaker, knee prosthesis, or metal implants in the lower legs.\n* Inability to walk or stand for at least 5 minutes.\n* Inability to understand, comprehend, or follow instructions required to conduct the study, or to provide informed consent.","50 Years","75 Years",{"count":54,"type":22},40,"INTERVENTIONAL",[57],"PHASE2","This study aims to determine whether peripheral magnetic stimulation (PMS) during balance training in patients with diabetic polyneuropathy reduces fall risk, as measured by balance tests, and lessens disease severity compared to balance training with sham stimulation.\n\nThis proof-of-concept study will utilize the Magnetic and Balance Training Activator (MAGBATA), a platform mounted with a magnetic stimulation coil that delivers electromagnetic pulses directly to the plantar surfaces of the feet while patients stand. A racetrack coil (RT-120), connected to the MagPro X100 magnetic stimulator with MagOption (MagVenture, Farum, Denmark), will be used. Parameters for the repetitive peripheral magnetic stimulation (rPMS) protocol will be configured to facilitate sensory input, enhance brain plasticity, and promote axonal regeneration.",[26],[61,62,63,64,65],"diabetic polyneuropathy","peripheral magnetic stimulation","balance training","physical performance","postural control","RECRUITING","2026-03-26",{"date":69,"type":36},"2026-04-01",{"date":71,"type":36},"2025-06-10",{"date":73,"type":22},"2026-07-31",{"name":75,"class":43},"Queen Savang Vadhana Memorial Hospital, Thailand",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":85,"maxAge":52,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":88,"conditions":89,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":4},"100629873","serum-neurofilament-light-chain-levels-and-neuropathy-severity-in-diabetic-polyneuropathy-100629873","NCT07480330","Serum Neurofilament Light Chain Levels and Neuropathy Severity in Diabetic Polyneuropathy","Association Between Serum Neurofilament Light Chain (NfL) Levels and Neuropathy Severity, Balance Performance, and Fall Risk in Diabetic Polyneuropathy","DPN-NFL","Inclusion Criteria:\n\nInclusion Criteria Age between 30 and 75 years Diagnosis of Type 2 Diabetes Mellitus for at least 1 year Ability to understand and complete clinical assessments and questionnaires Willingness to participate and provide written informed consent\n\nFor the DPN+ group:\n\nPresence of diabetic polyneuropathy confirmed by clinical examination, Michigan Neuropathy Screening Instrument (MNSI), and nerve conduction studies\n\nFor the DPN- group:\n\nType 2 diabetes mellitus without clinical or electrophysiological evidence of diabetic polyneuropathy\n\nExclusion Criteria:\n\n* Neuropathy due to causes other than diabetes (e.g., vitamin B12 deficiency, hypothyroidism, alcohol abuse, chemotherapy) Renal dysfunction (eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m²) Active infection or malignancy Inflammatory or autoimmune neurological diseases Central nervous system disorders (e.g., stroke, multiple sclerosis) Lumbar radiculopathy or peripheral entrapment neuropathy Severe visual impairment or balance disorders affecting testing Pregnancy Cognitive impairment preventing completion of questionnaires Patients with isolated small fiber neuropathy without electrophysiological evidence of large fiber involvement","30 Years",{"count":87,"type":22},80,"Diabetic polyneuropathy (DPN) is one of the most common chronic complications of diabetes mellitus and is characterized by peripheral nerve damage caused by long-term hyperglycemia. Progressive sensory loss and impairment of proprioception may lead to balance disturbances, gait instability, and an increased risk of falls. Neurofilament Light Chain (NfL) has emerged as a potential biomarker of neuroaxonal injury in several neurological disorders.\n\nThe aim of this observational cross-sectional study is to investigate the relationship between serum Neurofilament Light Chain (NfL) levels and neuropathy severity, balance performance, and fall risk in patients with diabetic polyneuropathy. Neuropathy severity will be evaluated using the Michigan Neuropathy Screening Instrument (MNSI) and electrophysiological findings, while balance performance and fall risk will be assessed using the Berg Balance Scale and the Falls Efficacy Scale-International (FES-I).",[26],"2026-03-14",{"date":92,"type":36},"2026-03-18",{"date":94,"type":22},"2026-03-25",{"date":96,"type":22},"2026-05-15",{"name":98,"class":43},"Kanuni Sultan Suleyman Training and Research Hospital",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":55,"phases":110,"briefSummary":112,"conditions":113,"keywords":117,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":76},"100629468","phase-2-the-effect-of-oral-dlbs1033-in-patients-with-diabetic-polyneuropathy-100629468","NCT07475065","The Effect of Oral DLBS1033 in Patients With Diabetic Polyneuropathy","The Effect of Oral DLBS1033 as Adjuvant Therapy on Inflammatory Biomarkers, Neuroregeneration Biomarkers, and Disease Severity in Patients With Diabetic Polyneuropathy: A Randomized Controlled Trial (An Evaluation of Changes in TCNS, TNF-α, NGF, and Sensory Nerve Conduction Study of the Sural Nerve)","Inclusion Criteria:\n\n* Adults aged 40-60 years diagnosed with diabetic polyneuropathy by a neurologist or neurology resident.\n* Patients with HbA1c levels between 7-10% within the past 30 days.\n* Willing to participate and able to sign the informed consent form.\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding, or planning pregnancy.\n* History of other neurological diseases such as stroke, myelopathy, alcoholic neuropathy, or compressive radiculopathy.\n* Significant renal impairment (creatinine \\> 1.5× upper limit of normal), hepatic impairment (SGOT or SGPT \\> 3× upper limit of normal), or severe cardiac disease (NYHA class III-IV heart failure).\n* History of alcohol consumption for ≥ 5 consecutive years.\n* Heavy smoker (Brinkman Index \\> 600).\n* Known allergy or intolerance to DLBS1033.\n* Autoimmune disease, malignancy, or acute and\u002For chronic inflammatory conditions other than diabetic polyneuropathy.\n* Participation in another interventional pharmacological clinical study within 30 days prior to screening.\n* Currently taking anti-inflammatory and\u002For antioxidant medications.","40 Years","60 Years",{"count":109,"type":22},34,[57,111],"PHASE3","This study aims to evaluate whether oral DLBS1033 can improve clinical symptoms and biological markers of nerve damage in adults with diabetic polyneuropathy. The trial enrolls patients with type 2 diabetes who show clinical signs of peripheral nerve injury.\n\nParticipants will receive either DLBS1033 as adjuvant therapy or standard therapy alone for 28 days. The study will compare changes in neuropathy severity (Toronto Clinical Neuropathy Score), inflammatory biomarkers (TNF-α), neuroregeneration biomarkers (Nerve Growth Factor), and sensory nerve conduction parameters of the sural nerve between the two groups. Blood tests, clinical assessments, and nerve conduction studies will be performed at baseline and follow-up visits. Participants will also report any symptoms or adverse events throughout the study.",[26,114,115,116],"Peripheral Nervous System Diseases","Peripheral Neuropathy","Diabetes Mellitus",[118,119,61,120,121,122,123,124,125,126,127,128,129,130],"DLBS1033","lumbrokinase","peripheral neuropathy","Toronto Clinical Neuropathy Score","TNF-α","TNF-alpha","Nerve Growth Factor","sural nerve","nerve conduction study","NCS","EMG","ENMG","Electromyography","2026-03-13",{"date":133,"type":36},"2026-03-16",{"date":135,"type":22},"2026-03-01",{"date":137,"type":22},"2026-06-30",{"name":139,"class":43},"Universitas Sebelas Maret",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":146,"maxAge":107,"enrollmentInfo":147,"targetDuration":4,"studyType":55,"phases":148,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":159,"locationsCount":76},"100624083","effect-of-vagus-nerve-stimulation-on-pain-intensity-nerve-conduction-studies-and-functional-outcomes-in-diabetic-peripheral-neuropathy-patients-100624083","NCT07405021","Effect of Vagus Nerve Stimulation on Pain Intensity, Nerve Conduction Studies and Functional Outcomes in Diabetic Peripheral Neuropathy Patients","Inclusion Criteria\n\n* Thirty patients diagnosed with diabetic neuropathy of both genders.\n* Age range between 45 and 60 years.\n* Presence of numbness and\u002For pain in the feet with no other identifiable cause.\n* Pain characterized as stabbing, electric shock-like, or burning in nature.\n* Presence of glove-stocking sensory changes and abnormal sensations in the distal lower limbs.\n* Ability to ambulate independently without assistance.\n* Patients under full medical control.\n* Hemoglobin A1c levels ranging from 6.5% to 7%.\n* History of diabetes mellitus for more than 5 years.\n\nExclusion Criteria\n\n* Implantation of cardiac pacemakers or other electrical stimulation devices.\n* Presence of sinus bradycardia, sick sinus syndrome, or other cardiac arrhythmias.\n* Lumbar radiculopathy.\n* Psychiatric or mental disorders or history of seizures.\n* Visual or auditory impairments or tremors affecting balance.\n* Presence of other neuromuscular disorders.\n* Foot deformities or active foot ulcers.\n* History of lower limb surgical operations.","45 Years",{"count":54,"type":22},[149],"NA","To evaluate the efficacy of vagus nerve stimulation in reducing neuropathic pain, symptom severity, electrophysiological studies and functional outcomes in patients with diabetic peripheral neuropathy.",[152,26],"Transcutaneous Vagal Nerve Stimulation (tVNS)","2026-02-09",{"date":155,"type":36},"2026-02-12",{"date":157,"type":36},"2026-01-01",{"date":69,"type":22},{"name":160,"class":43},"Cairo University",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":17,"minAge":169,"maxAge":4,"enrollmentInfo":170,"targetDuration":4,"studyType":55,"phases":172,"briefSummary":173,"conditions":174,"keywords":182,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":76},"100525657","early-percutaneous-transluminal-angioplasty-in-diabetic-foot-syndrome-pta-dfs-100525657","NCT06124586","Early Percutaneous Transluminal Angioplasty in Diabetic Foot Syndrome (PTA-DFS)","Role of Percutaneous Transluminal Angioplasty for Wound Healing and Dynamics of the Microbial Community in Patients With Type 2 Diabetes and Diabetic Foot Syndrome","PTA-DFS","Inclusion Criteria:\n\n* volunteer adults\n* written informed consent\n* presence of known manifest T2D and fulfilment of the following criteria:\n* HbA1c \\\u003C 10%\n* presence of pAVD with fulfillment of the following criteria:\n* PAD Stage After Fontaine IV (foot ulcer)\n* Presence of foot ulcer with fulfillment of the following criteria:\n* Foot ulceration without indication for emergency surgical care from stage Wagner 1.\n* Age \\>18 years\n\nExclusion Criteria:\n\n* Acute leg ischemia (sudden onset, sensorimotor deficits, pale extremity, pain, loss of pulse, and shock).\n* Type 1 diabetes mellitus (GADA, ICA, IA-2A, ZnT8A positive).\n* Minors or subjects incapable of giving consent\n* Pregnant or breastfeeding women\n* Treatment with certain drugs (immunosuppressive therapy,\n* Immunomodulators, chemotherapy, antibiotic therapy \\\u003C 2 weeks before\n* intervention)\n* Diseases of the pancreas\n* Severe neurological or psychiatric disease\n* Known presence of malignant tumor disease within the past 5 years\n* Participation in other interventional trials and receipt of investigational medication within the last 30 days\n* Blood or plasma donation within the last 3 months","18 Years",{"count":171,"type":22},200,[149],"The planned study is a Randomized Controlled Monocentric Trial, which will provide evidence on whether early angiography in percutaneous transluminal angioplasty (PTA) readiness (\"immediate\" treatment, within 48h) has advantages over the \"standard of care\", i.e., an elective procedure (\"elective PTA\") for the treatment of diabetic foot ulcer (DFU). The primary study endpoint is to investigate the impact of the \"early PTA\" within 48 hours on wound-healing assessed by wound area changes after PTA using a 3D-camera with artificial intelligence (AI)-based wound-analysis-system. The secondary endpoint is the effect of early PTA on the combined occurrence of major adverse limb (MALE) and cardiac events (MACE) over 12 months post-angioplasty using time-to-event analysis. Data will be collected at baseline, 24 hours, 1, 2, 3, 6, and 12 months after PTA. Diabetic kidney disease, distal symmetric polyneuropathy, retinopathy, cardiomyopathy, laboratory analyses, clinical scores, AI-based fundus photography, echocardiography, duplex sonography, and pulse oscillography will be assessed. Explanatory variables for wound healing are wound microbiome changes using whole-genome sequencing and oxygen saturation of the wound environment measured using near-infrared spectroscopy. Altered microbiome composition in ulcers can lead to severe local and systemic infections and complications, including major amputations. Nevertheless, the specific significance of the wound microbiome composition in chronic ischaemic ulcers in type 2 diabetes and the impact of PTA on the wound microbiome in type 2 diabetes is unclear. The exact timing for treating peripheral arterial disease (PAD) by revascularization in DFU after initial diagnosis is unknown and has yet to be fully understood.",[175,116,176,177,178,179,180,181,26],"Diabetic Foot","Peripheral Arterial Disease","Diabetic Neuropathies","Diabetic Retinopathy","Anemia","Ulcer Foot","Ulcer Ischemic",[183,184,185,186,187],"diabetic foot syndrome","peripheral artery disease","diabetic food ulcers","microbiome","percutaneous transluminal angioplasty","2026-02-03",{"date":190,"type":36},"2026-02-04",{"date":192,"type":36},"2024-02-01",{"date":194,"type":22},"2028-11-01",{"name":196,"class":43},"Heinrich-Heine University, Duesseldorf",{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":17,"minAge":204,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":55,"phases":208,"briefSummary":209,"conditions":210,"keywords":211,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":76},"100612057","combined-effects-of-foot-ankle-therapeutic-exercises-and-mindful-walking-in-patients-with-diabetic-polyneuropathy-100612057","NCT07248631","Combined Effects of Foot-Ankle Therapeutic Exercises and Mindful Walking in Patients With Diabetic Polyneuropathy","Combined Effects of Foot-Ankle Therapeutic Exercises and Mindful Walking on Pain, Foot and Ankle Disability and Quality of Life in Patients With Diabetic Polyneuropathy","Inclusion Criteria:\n\n* Diagnosed with diabetic polyneuropathy (DPN) confirmed by medical history and clinical examination.\n* Experience pain and disability in foot\u002Fankle, with a Numeric Pain Rating Scale (NPRS) score ≥ 4.\n* Independent walking ability for at least 10 m.\n* Age (40-75) years.\n* Ability to understand and follow exercise instructions.\n* A maximum of one amputated toe, not being the hallux.\n* Willingness to participate in the study and provide informed consent.\n\nExclusion Criteria:\n\n* Presence of an active plantar ulcer or gangrene.\n* History of surgical procedure at the knee, ankle, or hip or indication of surgery throughout the intervention period.\n* Arthroplasty and\u002For orthosis of lower limbs or indication of lower limb arthroplasty throughout the intervention period.\n* Participating in other exercise programs or studies.\n* Dementia or inability to give consistent information.\n* Diagnosis of neurological diseases.\n* Neuropathic pain due to other causes (e.g., HIV, chemotherapy).\n* Major vascular complications and\u002For severe retinopathy.","40 Months","75 Months",{"count":207,"type":22},38,[149],"The aim of this study is to investigate the combined effects of foot ankle therapeutic exercises and mindful walking on pain, foot and ankle disability, and quality of life in patients with diabetic polyneuropathy. This study seeks to evaluate the efficacy of these interventions in improving clinical outcomes and enhancing the overall well-being of individuals with diabetic polyneuropathy.",[26],[212,213,214,215,26,216],"Pain","Quality of life","Foot-Ankle therapeutic Exercises","Mindful Walking","Foot and Ankle Disability","2025-11-18",{"date":219,"type":36},"2025-11-25",{"date":221,"type":36},"2024-10-17",{"date":223,"type":22},"2025-12-30",{"name":225,"class":43},"Riphah International University",{"id":227,"slug":228,"hasResults":11,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":16,"sex":17,"minAge":169,"maxAge":19,"enrollmentInfo":233,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":235,"conditions":236,"keywords":238,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":253},"100575878","investigation-of-ultrasonographic-measurements-of-lower-extremity-nerves-in-type-2-diabetes-patients-with-peripheral-polyneuropathy-100575878","NCT06778005","Investigation of Ultrasonographic Measurements of Lower Extremity Nerves in Type 2 Diabetes Patients With Peripheral Polyneuropathy","Investigation of the Relationship of Ultrasonographic Measurements of Lower Extremity Nerves With Gait and Balance Performance in Type 2 Diabetes Patients With Peripheral Polyneuropathy","Inclusion Criteria (Group 1):\n\n* Being between the ages of 18-65\n* Being literate\n* Signed a voluntary consent form agreeing to participate in the study\n\nInclusion Criteria (Group 2):\n\n* Diagnosed with Type 2 Diabetes based on at least one of the following diagnostic criteria: fasting plasma glucose ≥ 126 mg\u002Fdl, 2-hour plasma glucose ≥ 200 mg\u002Fdl in an oral glucose tolerance test, HbA1c ≥ 6.5%, or diabetes symptoms (excessive thirst, eating, urination, and weight loss) + random plasma glucose ≥ 200 mg\u002Fdl. (14)\n* Diagnosed with diabetic peripheral polyneuropathy through EMG evaluation in addition to Type 2 Diabetes.\n* Being between the ages of 18-65\n* Being literate\n* Signed a voluntary consent form agreeing to participate in the study.\n\nExclusion Criteria:\n\n* Individuals under 18 years old and over 65 years old\n* Diagnosed with Type 1 diabetes\n* Use of medications that can cause polyneuropathy\n* Other causes of neuropathic pain (lumbar radiculopathy, spinal stenosis, -hereditary, inflammatory, entrapment neuropathies)\n* Undergoing lower extremity surgery (spine\u002Fhip\u002Fknee\u002Ffoot) in the last 6 months\n* Having peripheral artery disease\n* B12 vitamin deficiency\n* Active foot ulcer\n* History of lower extremity amputation\n* Severe cardiopulmonary insufficiency (stage 3-4)\n* History of myocardial infarction within the last 1 month\n* History of unstable angina\n* Active systemic inflammatory diseases and active malignancy\n* Presence of vestibular disorders\n* Presence of cognitive impairment\n* Osteoarthritis in the lower extremity\n* Pregnancy\n* Body Mass Index (BMI) of 30 or higher",{"count":234,"type":22},86,"The aim of this study is to quantitatively evaluate ultrasonographic measurements of the lower extremity nerves in patients diagnosed with diabetic polyneuropathy and to investigate the relationship with gait, static and dynamic balance performance.\n\nIn this study, we aimed to investigate the effect of ultrasonographic findings of lower extremity nerves on quality of daily life, physical activity, gait and balance in patients with diabetic peripheral polyneuropathy.",[237,26],"Diabetes",[239,240,241,242,243],"polyneuropathy","Ultrasound","diabetes","balance","gait","2025-09-05",{"date":246,"type":36},"2025-09-12",{"date":248,"type":36},"2025-01-01",{"date":250,"type":22},"2025-11-01",{"name":252,"class":43},"Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey",2,{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":16,"sex":17,"minAge":169,"maxAge":261,"enrollmentInfo":262,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":264,"conditions":265,"keywords":274,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":76},"100519209","polyneuropathy-impairments-and-physical-activity---the-polyimpact-study-100519209","NCT06040567","Polyneuropathy, Impairments and Physical Activity - The PolyImPAct Study","PolyImPAct","Inclusion Criteria:\n\nInclusion Criteria patients:\n\n\\> 18 years Diagnosed with polyneuropathy (verified by nerve conduction)\n\nInclusion Criteria healthy controls:\n\n\\> 18 years Healthy\n\nExclusion Criteria:\n\nExclusion Criteria patients:\n\nNot verified polyneuropathy\n\nExclusion Criteria healthy controls:\n\nDiabetes, brain-, nerve-, muscle-, kidney-, or liver disease. Diagnosed with polyneuropathy","100 Years",{"count":263,"type":22},520,"The project aims to investigate the validity, and reliability of outcome measures of muscle strength, functioning (gait, balance, and fine motor skills), physical activity, and patient-reported outcome measures of functioning (gait, balance, and fine motor skills), and daily living among patients with polyneuropathy. Further, the project aims to compare physical activity and patient-reported outcome measures of functioning (gait, balance, and fine motor skills), and daily living among patients with polyneuropathy with physical activity and patient-reported outcome measures of functioning (gait, balance, and fine motor skills) and daily living in healthy adults.",[266,267,268,269,270,271,26,272,273],"Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","Vasculitic Neuropathy","POEMS Syndrome","Multifocal Motor Neuropathy","Charcot-Marie-Tooth","hATTR Amyloidosis","Idiopathic Neuropathy","Polyneuropathies",[275,276,277,278,279,280,281,282],"Polyneuropathy","Clinical outcome measures","Patient reported outcome measures (PROMs)","Physical activity","Accelerometer","Validity","Reliability","Responsiveness","2025-04-03",{"date":285,"type":36},"2025-04-06",{"date":287,"type":36},"2023-09-23",{"date":289,"type":22},"2026-12-31",{"name":291,"class":43},"Rigshospitalet, Denmark",{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":4,"eligibilityCriteria":298,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":299,"enrollmentInfo":300,"targetDuration":4,"studyType":55,"phases":302,"briefSummary":303,"conditions":304,"keywords":306,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":76},"100572889","driving-with-neuropathy-100572889","NCT06739135","Driving with Neuropathy","Enabling People with Diabetic Neuropathy to Drive Safely: a Proof of Concept Randomised Controlled Trial","Inclusion Criteria:\n\n* Able to understand English and all of the study requirements, including ability to provide informed consent\n* Current full UK driving licence held, and for a minimum of 5 years (experienced drivers)\n* Drives a car at least once per week on average (current drivers)\n* Diagnosed with type 2 diabetes and diabetic peripheral neuropathy\n* Diagnosed with type 2 diabetes only (no diagnosed diabetic peripheral neuropathy)\n\nExclusion Criteria:\n\n* Active foot ulcer on either foot\n* Lower limb amputation involving more than two toes on the right foot\n* Dementia\n* Current participation in another research study that would compromise safety, or scientific integrity of either study (for example, a pharmaceutical trial that may affect ability to drive safely).","69 Years",{"count":301,"type":22},115,[149],"This study is a proof-of-concept randomised controlled trial (RCT). The goal of the study is to investigate the effectiveness of a feedback intervention to improve use of the accelerator pedal in patients driving with diabetes and peripheral neuropathy (DPN).\n\nThe main (primary) question it aims to answer is:\n\nWhat is the effect of a visual feedback intervention (over 6 sessions a month apart), compared to no feedback, on accelerator pedal use by drivers with diabetic peripheral neuropathy?\n\nOur working hypothesis is that the visual feedback intervention will reduce the % of drive time with the accelerator pedal pushed down further than 9 degrees (about halfway down), the point at which the visual feedback (a warning signal) is triggered.\n\nSecondary research questions are:\n\n1. What is the effect of the feedback intervention on drivers with diabetic peripheral neuropathy at the first visit, and at the third visit? When does the biggest improvement happen? Our working hypothesis is that the visual feedback intervention will reduce the % of drive time spent driving with the accelerator pedal pushed down further than 9 degrees, the point at which the feedback is triggered, in the first visit (ie with the first exposure to feedback) and by additional amounts in subsequent visits ie there will be an immediate benefit, and additional benefits that accrue gradually with repetition over the 6 monthly visits.\n2. What is the effect of the feedback intervention on a second variable, % of drive time with the vehicle 'out of control'. Out of control is defined as extreme use of the steering wheel, large and rapid movements that reach the full range of motion of the steering wheel or large swings back and forth together with excursion out of lane which the driver fails to prevent.\n\nOur working hypothesis is that the visual feedback intervention will reduce the % of drive time with the vehicle out of control.\n\nResearchers will compare the group of drivers with neuropathy who receive the intervention with a control group who do not.\n\nIn addition, a group of drivers who have diabetes but no diagnosed neuropathy will be studied. This is to seek confirmatory evidence (previously seen in a small sample in a previous study) that most drivers who have no diagnosed neuropathy do not push the accelerator pedal down more than 9 degrees and so do not need to improve their use of the accelerator pedal.\n\nParticipants will have their driving assessed in a driving simulator. Participants with DPN who push the accelerator pedal down more than 9 degrees will then be randomly allocated to the intervention group or control group. Only drivers in the intervention group will go on to experience the visual feedback intervention (in 6 sessions a month apart). Drivers in the control group will have their driving assessed at their first visit, and then at two later visits timed to coincide with the 3rd and 6th visit by drivers in the intervention group. This is the minimum necessary to be able to compare their driving with the intervention group at the start, midpoint and end of the intervention.",[26,305],"Diabetes Mellitus, Type 2",[307,308,309,310],"randomised controlled trial","diabetic peripheral neuropathy","driving","driving with neuropathy","2024-12-16",{"date":313,"type":36},"2024-12-18",{"date":315,"type":36},"2024-10-25",{"date":317,"type":22},"2026-07",{"name":319,"class":43},"Manchester Metropolitan University",{"id":321,"slug":322,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":17,"minAge":169,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":55,"phases":329,"briefSummary":330,"conditions":331,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":76},"100559749","phase-2-the-effect-of-alpha-lipoid-acid-and-vitamin-b-preparation-on-diabetic-polyneuropathy-in-type-2-diabetes-mellitus-patient-100559749","NCT06568185","The Effect of Alpha Lipoid Acid and Vitamin B Preparation on Diabetic Polyneuropathy in Type 2 Diabetes Mellitus Patient","The Effectiveness of Fixed Dose Combination of Alpha Lipoic Acid and Vitamin B Preparations for Treatment of Diabetic Polyneuropathy in Type 2 Diabetes Mellitus Patients: A Randomized Placebo-controlled Trial","Inclusion Criteria:\n\n1. Aged 18 years and over\n2. Diagnosed with type 2 diabetes mellitus based on WHO diagnostic criteria for diabetes (Organization, 2020).\n3. Diagnose with diabetic polyneuropathy by Neurological Symptom Score (NSS) and Neuropathy Disability Score (NDS).\n\nExclusion Criteria:\n\n1. Those with a documented mental impairment which impacted on their ability to answer questions independently.\n2. People with peripheral vascular disease (non-palpable foot pulses, intermittent claudication)\n3. People with an amputated foot or leg\n4. Abnormal liver enzyme.\n5. People with renal impairment.\n6. People using drugs with possible influence on the study results (antidepressants, anticonvulsants, opiates, neuroleptics, antioxidants, and particularly methylcobalamin, pyridoxine and other B complex preparations)\n7. Pregnancy, lactation, or childbearing age without safe contraception\n8. History of allergy with vitamin B complex preparations (i.e. Vitamin B12, B6 and B1) and alpha lipoic acid.",{"count":328,"type":22},76,[57],"To evaluate the efficacy of combination of vitamin B and alpha lipoic acid formulations for the treatment of diabetic polyneuropathy in individuals with type 2 diabetes mellitus.\n\nMethodology :\n\nThis is a single-center, randomized, double-blind, placebo-controlled trial study.\n\nStudy duration May 2024 - September 2025\n\nStudy location :\n\nThis study will be conducted at the Klinik Rawatan Keluarga and diabetes clinic Hospital Universiti Sains Malaysia.\n\nSource Reference :\n\nPeople with type 2 diabetes mellitus attending the Hospital Universiti Sains Malaysia.\n\nStudy source population :\n\nPeople with type 2 diabetes mellitus attended Klinik Rawatan Keluarga and diabetes clinic Hospital Universiti Sains Malaysia during the study period.",[26],"2024-08-20",{"date":334,"type":36},"2024-08-23",{"date":336,"type":36},"2024-05-27",{"date":338,"type":22},"2025-09-01",{"name":340,"class":43},"Universiti Sains Malaysia",{"id":342,"slug":343,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":11,"sex":17,"minAge":348,"maxAge":19,"enrollmentInfo":349,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":351,"conditions":352,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":76},"100555650","utilizing-the-michigan-neuropathy-screening-instrument-for-early-detection-of-diabetic-neuropathy-100555650","NCT06514846","Utilizing the Michigan Neuropathy Screening Instrument for Early Detection of Diabetic Neuropathy","Utilizing the Michigan Neuropathy Screening Instrument, Routine Nerve Conduction Study (NCS), and Nerve Ultrasound for Early Detection of Diabetic Neuropathy","Inclusion Criteria:\n\n* ü Age: 30-55 y\n\nü Type of diabetes: Type 2\n\nü Duration of diabetes: Within 1Year of diagnosis of Type 2 diabetes mellitus according to World Health Organization 1999 criteria\n\nExclusion Criteria:\n\n* Patients who had known conditions that could present with neuropathy such as hereditary sensory neuropathy, vitamin B12 or folate deficiency, paraneoplastic conditions, autoimmune diseases, uremia, hypothyroidism, and ethanol abuse.","33 Years",{"count":350,"type":22},100,"The study aims to Compare the diagnostic accuracy of the Michigan Neuropathy Screening Instrument (MNSI) (using MNS questionnaire, ,Inspection, vibratory sensation, Ankle reflexes Exam, 10 g monofilament needle examination), routine NCS, and the U\u002FS of the median, posterior tibial, and sural nerves in identifying diabetic peripheral neuropathy in patients recently diagnosed with type 2 diabetes.",[26],"2024-07-27",{"date":355,"type":36},"2024-07-30",{"date":357,"type":36},"2023-06-01",{"date":359,"type":22},"2025-06-01",{"name":361,"class":43},"Sohag University"]