[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"peripheral-neuropathy-with-type-2-diabetes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:peripheral-neuropathy-with-type-2-diabetes":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,47,75,100,130,159],{"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":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100589812","balance4mobility-effects-of-walkasins-use-in-individuals-with-peripheral-neuropathy-and-balance-problems-100589812",false,"NCT06959277","Balance4Mobility: Effects of Walkasins Use in Individuals With Peripheral Neuropathy and Balance Problems","Balance4Mobility: Effects of Walkasins Use on Clinical Outcomes of Gait and Balance Function in Individuals With Peripheral Neuropathy and Balance Problems - A Randomized Control Trial","Inclusion Criteria:\n\n* Able to understand and provide informed consent for him or herself\n* Age 55 and older, male or female\n* Able to complete all functional outcome measures without the use of an assistive device\n* Clinical diagnosis of peripheral neuropathy prior to participating in the study as documented in the participant's medical record or by physician's note. Individuals with chemo-induced peripheral neuropathy must be at least one-year post-chemotherapy, indicating that their PN has become a chronic condition.\n* Self-reported gait and balance problems\n* Foot size that allows the Walkasins to function appropriately\n* Willing to use the Walkasins device as recommended\n\nExclusion Criteria:\n\n* Ability to stand on one leg for at least 30 seconds (If the person can stand for at least 30 seconds, he\u002Fshe is excluded because his\u002Fher balance is likely not impaired enough to benefit from Walkasins.)\n* Self-reported acute thrombophlebitis, including deep vein thrombosis\n* Self-reported severe peripheral vascular disease\n* Untreated lymphedema\n* Untreated lesion of any kind, swelling, infection, inflamed area of skin or eruptions on the lower leg near product use\n* Self-reported, untreated fractures in the foot and ankle\n* Other neurological or musculoskeletal conditions that moderately or severely impact walking\n* Use of ankle-foot orthosis for ambulation that prevents donning of Walkasins\n* Weight of more than 300 pounds\n* Inability to perceive vibration from Walkasins Haptic Module","ALL","55 Years",{"count":19,"type":20},200,"ESTIMATED","INTERVENTIONAL",[23],"NA","The goal of this clinical trial is to is to test whether Walkasins can help people with peripheral neuropathy maintain their balance better. The main question it aims to answer is whether participants who use Walkasins on an everyday basis over a six-month period will report better awareness of their foot placement on the ground.\n\nResearchers will compare Walkasins users to a control group of participants who are not using Walkasins to see if the device improves the users' performance on some standing and walking tests. Control group participants will get Walkasins after six months of being in the study.\n\nDuring the study participants will be asked to do the following:\n\n* Answer questions about their medical history and balance.\n* Do some standing and walking tests. Some of the tests will be timed.\n* Attend study visits and participate in study phone calls.\n* Keep track of any falls and notify study staff if they fall.\n* Wear the Walkasins device on a regular basis.",[26,27,28,29,30],"Peripheral Neuropathies","Peripheral Neuropathy Due to Chemotherapy","Peripheral Neuropathy With Type 2 Diabetes","Balance Control in Elderly","Gait Disorders",[32,33,34],"Walkasins","Peripheral Neuropathy","Balance Problems","RECRUITING","2026-06-23",{"date":38,"type":39},"2026-06-24","ACTUAL",{"date":41,"type":39},"2025-06-17",{"date":43,"type":20},"2027-12-31",{"name":45,"class":46},"RxFunction Inc.","INDUSTRY",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":65,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100635573","wearable-sensory-prosthesis-to-improve-coordination-walking-and-physical-activity-100635573","NCT07554443","Wearable Sensory Prosthesis to Improve Coordination, Walking, and Physical Activity","Wearable Sensory Prostheses to Improve Neuromuscular Coordination, Walking Function, and Real-World Physical Activity","Inclusion Criteria:\n\n* Be 60 years of age or older\n* Have a diagnosis of PN with plantar sensory loss\n* Demonstrate balance impairment, defined as a Single-Leg Stance time of \\\u003C23 seconds\n* Be able to walk independently for at least 6 minutes without the use of an assistive device (rest breaks permitted)\n* Be willing to use the Walkasins device as recommended\n* Be willing to participate in all aspects of physical activity monitoring and study assessments\n\nExclusion Criteria:\n\n* Under 60 years old\n* Do not have a diagnosis of PN with plantar sensory loss\n* Self-reported acute thrombophlebitis, including deep vein thrombosis\n* Self-reported severe peripheral vascular disease\n* Untreated lymphedema\n* Untreated lesion of any kind, swelling, infection, inflamed area of skin or eruptions on the lower leg near product use\n* Self-reported, untreated fractures in the foot and ankle\n* Other neurological or musculoskeletal conditions that moderately or severely impact walking\n* Use of ankle-foot orthosis for ambulation that prevents donning of Walkasins\n* Weight of more than 300 pounds\n* Inability to perceive vibration from Walkasins Haptic Module\n* Do not demonstrate balance impairments, defined as a Single-Leg Stance time of \\\u003C23 seconds","60 Years",{"count":56,"type":20},18,[23],"The goal of this clinical trial is to investigate whether sensory stimulations from a neuroprosthesis device (Walkasins®) can increase physical activity and improve gait quality in persons with peripheral neuropathy (PN). The main question it aims to answer is whether Walkasins enhances habitual activity patterns in adults with peripheral neuropathy.\n\nParticipants will do the following as part of the study:\n\n* Complete a sensation and balance assessment to determine eligibility for the study.\n* Answer questions about their medical history, physical function, balance confidence, and sleep.\n* Perform various balance and walking tasks on three separate occasions. One of the tests involves walking for six minutes without a cane or walker.\n* Wear an activPAL activity monitor for ten days on three separate occasions and return it to the researcher as directed.\n* Wear Walkasins for ten weeks as part of their daily routine. Walkasins consists of two parts: 1) an insole that fits inside the shoe and 2) a strap that secures around the ankle.",[28,60,61,62,63,64],"Peripheral Neuropathy Grade 2 or Greater","Balance","Balance Impairment, Gait Disorders, Fatigue","Balance Disorders","Physical Activities",[33,32,63,66],"Physical Activity","2026-06-22",{"date":69,"type":39},"2026-06-25",{"date":69,"type":20},{"date":72,"type":20},"2027-12",{"name":45,"class":46},1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":74},"100642342","frequency-rhythmic-electrical-modulated-stimulation-effect-in-peripheral-neuropathy-patients-severity-of-cases-and-qol-100642342","NCT07645482","Frequency Rhythmic Electrical Modulated Stimulation Effect in Peripheral Neuropathy Patients Severity of Cases and Qol.","Effects Of Frequency Rhythmic Electrical Modulated Stimulation (FREMS) On Blood Perfusion, Neuropathy Severity And Quality Of Life In Diabetic Patients With Peripheral Neuropathy And Lower Limb Ischemia: A Randomized Controlled Trial.","FREMS","Inclusion Criteria:\n\n* patients diagnosed with DM\n* patients age group above 40 years old.\n* patient diagnosed with peripheral neuropathy with symptoms lasts more than 3 months.\n* patients lower limb ischemia in duplex affected APSV.\n\nExclusion Criteria:\n\n* patients with implant peacemakers, defibrillator, or neurostimulator.\n* pregnancy.\n* any severe disease prevent compliance to study procedures.\n* patients with disabilities prevent their commitment to sessions.","40 Years",{"count":85,"type":20},40,[23],"It's estimated that 50% of diabetic patients will have peripheral neuropathy as a complication within 3 years of the diabetes incidence \\[14\\], the goal of the study is to investigate this problem through the following objectives:\n\n1. To measure the effect of using FREMS therapy in diabetic neuropathy in interventional group on the blood perfusion, neuropathy severity and quality of life after 10 sessions compared to baseline.\n2. To measure the effect of using standard of care in diabetic neuropathy in control group on the blood perfusion, neuropathy severity and quality of life after 10 sessions compared to baseline.\n3. To compare the results between both interventional and control group.",[28],"NOT_YET_RECRUITING","2026-06-09",{"date":92,"type":39},"2026-06-12",{"date":94,"type":20},"2026-07",{"date":96,"type":20},"2026-08",{"name":98,"class":99},"Beni-Suef University","OTHER",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":107,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":21,"phases":110,"briefSummary":111,"conditions":112,"keywords":116,"overallStatus":89,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":4},"100639513","risk-perception-intervention-for-high-risk-diabetic-foot-100639513","NCT07581262","Risk Perception Intervention for High-Risk Diabetic Foot","Construction and Application of a Foot Ulcer Risk Perception Intervention Program for Diabetic Patients With High-risk Foot Based on Information Framework Effect","Inclusion Criteria:\n\n1. Age ≥ 18 years old with good communication and cognitive abilities.\n2. Meet the World Health Organization (WHO) diagnostic criteria for Type 1 or Type 2 Diabetes Mellitus.\n3. Meet the diagnostic criteria for high-risk diabetic foot according to the International Working Group on the Diabetic Foot (IWGDF) 2023 standards.\n4. Proficient in the use of a smartphone and related applications (e.g., WeChat).\n5. Voluntarily participate in the study and provide signed informed consent.\n\nExclusion Criteria:\n\n1. Patients with impaired consciousness, severe organ dysfunction, or other physical disabilities that lead to being bedbound or unable to perform foot care.\n2. Patients with peripheral neuropathy caused by non-diabetic factors (e.g., toxic, nutritional, or hereditary neuropathies).\n3. Patients with gestational diabetes or those with pre-existing diabetes who are currently pregnant.","18 Years",{"count":109,"type":20},90,[23],"This study aims to evaluate the effect of health education based on information framing effects on foot ulcer risk perception in patients at high risk of diabetic foot.\n\nStudy Design:\n\nA randomized controlled trial with three groups:\n\nExperimental Group 1 (Gain-Framed): Participants received a benefit framing message that emphasized the benefits of standardized foot care in reducing the likelihood and severity of foot ulcers, with an aim to reshape patients' perception of risk.\n\nExperimental Group 2 (Loss-Framed):Participants received a loss frame message that emphasized that neglecting foot care would increase the likelihood and severity of foot ulcers. The message was designed to awaken patients' awareness of crisis and risk perception.\n\nControl Group (Routine Messaging):Participants received the usual content of care in the endocrinology department without a specific framework.\n\nParticipants:\n\nDiabetic foot patients at high risk from experimental group 1, experimental group 2, and control group 3. Inclusion criteria included adults with a diagnosis of diabetic foot at high risk.\n\nIntervention:\n\nThe Total Study Period consisted of an intervention phase and a follow-up phase. The intervention phase started at the time of enrollment and lasted until the fourth week after discharge. The follow-up period lasted for 3 months. Data on local indicators were collected at baseline\u002Fbefore the intervention (T0), immediately after the intervention (T1), 1 month after the intervention (T2) and 3 months after the intervention (T3).\n\nOutcome Measures:\n\nPrimary Outcomes:\n\nFoot ulcer risk perception: Assessed using The Tripartite Model of Risk Perception Scale.\n\nSecondary Outcomes:\n\nFoot care behavior score: Assessed using The Nottingham Foot Care Assessment Scale; Self-efficacy: Assessed using The Diabetes Self-Efficacy Scale; Intention to delay seeking medical help score:Assessed using the Questionnaire on Intention to Delay Seeking Medical Care for Patients with High-Risk Diabetic Foot; the incidence\u002Frecurrence rate of foot ulcers, and various laboratory indicators.",[113,114,115,28],"Diabetes Mellitus","Diabetic Foot Ulcer (DFU)","Risk Perception",[117,118,119,120],"diabetes mellitus","high risk foot","diabetic foot ulcer","risk perception","2026-05-06",{"date":123,"type":39},"2026-05-12",{"date":125,"type":20},"2026-05-01",{"date":127,"type":20},"2026-12-31",{"name":129,"class":99},"The Third Affiliated Hospital of Soochow University",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":107,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":21,"phases":138,"briefSummary":139,"conditions":140,"keywords":143,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":74},"100632129","the-treatment-of-painful-diabetic-neuropathy-with-diet-100632129","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",{"count":85,"type":20},[23],"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.",[141,28,142],"Painful Diabetic Neuropathy (PDN)","Vegan Diet",[144,145,146,147,148,149],"painful","diabetic","neuropathy","peripheral neuropathy","diabetes","diabetes type 2","2026-04-27",{"date":152,"type":39},"2026-04-30",{"date":154,"type":39},"2024-04-23",{"date":156,"type":20},"2028-02-28",{"name":158,"class":99},"AdventHealth",{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":165,"maxAge":166,"enrollmentInfo":167,"targetDuration":4,"studyType":21,"phases":168,"briefSummary":169,"conditions":170,"keywords":171,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":74},"100483619","a-physiologic-comparison-of-two-approaches-to-treating-peripheral-neuropathy-100483619","NCT05577390","A Physiologic Comparison of Two Approaches to Treating Peripheral Neuropathy","Inclusion Criteria:\n\n* Between the ages of 45 and 85\n* Moderate to severe type II diabetic neuropathy with one or more symptoms including: numbness, tingling, burning, sharp pain, and\u002For increased sensitivity.\n* Diagnosis confirmed by a physician.\n* Cellphone access with Android 5.0 and up or iOS 14.0 or later.\n\nExclusion Criteria:\n\nSubjects with a medical condition predisposing them to medical decline during the next 6 months will be excluded from the study. Examples include:\n\n* Chemotherapy\n* Radiation\n* Lower extremity amputations\n* Open wounds\n* Documented active drug and or alcohol misuse\n* Chronic liver disease\n* Active inflammations\n* Other types of neuropathies not associated with diabetes including B12 deficiency and Charcot Marie Tooth\n* Morbid obesity\n* Pregnancy.\n* Taking beta blockers\n* Unable to maintain steady fingers or operate a cellphone\n* Smoking or ingesting marijuana\n* Having a pacemaker\n* Allergies to cobalt, chrome, or nickel","45 Years","85 Years",{"count":85,"type":20},[23],"Diabetic peripheral neuropathy is one of the most common and costly microvascular complications of diabetes impacting more than 50% of patients and costing more than 10.1 billion dollars annually. Intraneural Facilitation Therapy (INF® Therapy) is a non-invasive technique that has shown to improve balance and pain in patients with Type 2 Diabetic Peripheral Neuropathy (T2DPN); however, the underlying physiological mechanisms need further understanding. The purpose of this study is to investigate the physiological mechanisms behind two approaches to treating T2DPN, INF® Therapy and standard physical therapy. Eligible subjects presenting with diabetic neuropathy symptoms will be recruited and referred to the Loma Linda University Health's Neuropathic Therapy Center. Forty patients will be evenly randomized into two groups: an INF® Therapy Treatment group and standard physical therapy treatment group. Subjects will participate in 11 study visits over a period of 6 weeks. Non-invasive assessments will measure neuropathy pain, heart rate variability, neuropathy severity, blood oxygen levels, and blood flow under the skin. Lab draws will measure inflammation levels in the blood and how well blood sugar levels have been maintained over a period of about 3 months. Descriptive statistics and repeated measures ANOVA will be used to analyze data and answer the research questions. The findings of this study will provide a better understanding of how INF® Therapy and standard physical therapy work, subsequently improving non-invasive treatment methods for T2DPN patients.",[28],[172,173,174,175],"Intraneural Facilitation Therapy","Type 2 Diabetes","Neuropathy","Heart rate variability","2025-11-17",{"date":178,"type":39},"2025-11-19",{"date":180,"type":39},"2024-01-08",{"date":182,"type":20},"2027-08-01",{"name":184,"class":99},"Loma Linda University"]