[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabetic-neuropathies\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabetic-neuropathies":46},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,73,102,124,156,193,221,256,279,300,331,357,391,432,456,476,500,522,544,566],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":53,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100270060","neurologic-stem-cell-treatment-study-100270060",false,"NCT02795052","Neurologic Stem Cell Treatment Study","Neurologic Bone Marrow Derived Stem Cell Treatment Study","NEST","Inclusion Criteria:\n\n1. Have documented functional damage to the central or peripheral nervous system unlikely to improve with present standard of care.\n2. Be at least 6 months post-onset of the disease.\n3. If under current medical therapy (pharmacologic or surgical treatment) for the condition be considered stable on that treatment and unlikely to have reversal of the associated neurologic functional damage as a result of the ongoing pharmacologic or surgical treatment.\n4. In the estimation of Dr. Weiss and the neurologists have the potential for improvement with BMSC treatment and be at minimal risk of any potential harm from the procedure.\n5. Be over the age of 18 and capable of providing informed consent.\n6. Be medically stable and able to be medically cleared by their primary care physician or a licensed primary care practitioner for the procedure. Medical clearance means that in the estimation of the primary care practitioner, the patient can reasonably be expected to undergo the procedure without significant medical risk to health.\n\nExclusion Criteria:\n\n1. All patients must be capable of an adequate neurologic examination and evaluation to document the pathology. This will include the ability to cooperate with the exam.\n2. Patients must be capable and willing to undergo follow up neurologic exams with the sub-investigators or their own neurologists as outlined in the protocol.\n3. Patients must be capable of providing informed consent.\n4. In the estimation of Dr. Weiss the BMSC collection and treatment will not present a significant risk of harm to the patient's general health or to their neurologic function. .\n5. Patients who are not medically stable or who may be at significant risk to their health undergoing the procedure will not be eligible.\n6. Women of childbearing age must not be pregnant at the time of treatment and should refrain from becoming pregnant for 3 months post treatment.","ALL","18 Years",{"count":20,"type":21},500,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a human clinical study involving the isolation of autologous bone marrow derived stem cells (BMSC) and transfer to the vascular system and inferior 1\u002F3 of the nasal passages in order to determine if such a treatment will provide improvement in neurologic function for patients with certain neurologic conditions. http:\u002F\u002Fmdstemcells.com\u002Fnest\u002F",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52],"Neurologic Disorders","Nervous System Diseases","Neurodegenerative Diseases","Neurological Disorders","Stroke","Traumatic Brain Injury","Cadasil","Chronic Traumatic Encephalopathy","Cerebral Infarction","Cerebral Ischemia","Cerebral Stroke","Cerebral Hemorrhage","Parkinson","Multi-System Degeneration","MSA - Multiple System Atrophy","Progressive Supranuclear Palsy","ALS","Amyotrophic Lateral Sclerosis","Neuropathy","Diabetic Neuropathies","Alzheimer Disease","Dementia","Frontotemporal Dementia","Lewy Body Disease","Cognitive Impairment","Lewy Body Variant of Alzheimer Disease",[54,55,31,32,56,57,45,58,36,51,48,59],"Neurologic Disease","Cerebral Vascular Accident","Multiple Sclerosis","Parkinsons Disease","Diabetic Neuropathy","Neurodegeneration","RECRUITING","2026-06-24",{"date":63,"type":64},"2026-06-26","ACTUAL",{"date":66,"type":64},"2016-06",{"date":68,"type":21},"2028-07-31",{"name":70,"class":71},"MD Stem Cells","INDUSTRY",3,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100640824","tscs-and-ar-on-pain-and-balance-in-diabetic-peripheral-neuropathy-100640824","NCT07619794","tSCS and AR on Pain and Balance in Diabetic Peripheral Neuropathy","Combined Effects of Transcutaneous Spinal Cord Stimulation (tSCS) and Augmented Reality (AR) Training on Pain and Balance in Diabetic Neuropathy Patients.","Inclusion Criteria:\n\n* More than or equals to 4 score on Douleur Neuropathique 4 Questionnaire\n* More than or equals to 6 Hz at Neurothesiometer\n* More than or equals to 4 score on the Numeric Pain Rating Scale (NPRS)\n\nExclusion Criteria:\n\n* Cognitively compromised (MOCA ≤ 26\u002F30)\n* Metallic implants at skull\n* Shunting\n* Skin allergy",{"count":81,"type":21},36,[24],"tSCS and AR-based training have individually shown benefits in neuromotor rehabilitation; no study to date has evaluated their combined effects on pain, balance, lower-limb strength, retention, and vibration sense in diabetic neuropathy. The rationale for combining them lies in their complementary mechanisms: tSCS at 30 Hz activates large-diameter Aβ afferents, inhibiting nociceptive input, enhancing spinal excitability, and facilitating motor activation.",[46],[86,87,88,89],"Spinal cord stimulation","diabetic peripheral neuropathy","pain","balance","NOT_YET_RECRUITING","2026-06-01",{"date":93,"type":64},"2026-06-02",{"date":95,"type":21},"2026-06-15",{"date":97,"type":21},"2027-01-31",{"name":99,"class":100},"Riphah International University","OTHER",1,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":17,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":101},"100638109","comparison-of-qigong-and-otago-in-patient-with-diabetic-neuropathy-100638109","NCT07575126","Comparison of Qigong and Otago in Patient With Diabetic Neuropathy","Comparison of Qigong and Otago on Agility, Balance, Gait, and Quality of Life in Patients With Diabetic Neuropathy","Inclusion Criteria:\n\n* Physician-diagnosed type 2 diabetes without gender bias, with peripheral neuropathy (defined by Michigan Neuropathy Screening Instrument questionnaire score of 5 or greater)\n* Type 2 diabetic peripheral neuropathy patients\n* The ability to walk independently for 10 m\n* Having score between 46 to 52 (out of a total of 56 points) on the BBS\n\nExclusion Criteria:\n\n* Fracture of the lower limb within the 6 months before the study (15)\n* Diabetic ulcer, infection or partial amputation in feet (15)\n* Disease or functional impairment of auditory, vestibular system (16)\n* Any other medical conditions that would confound assessment of neuropathy such as malignancy, other neurological or orthopedic impairments (such as stroke, poliomyelitis, rheumatoid arthritis, prosthesis, or severe osteoarthritis), major vascular complications (venous or arterial ulcers), severe retinopathy, or severe nephropathy that causes edema or needs hemodialysis (17)\n* Dementia or inability to give consistent information (18)\n* History of surgical procedure at the knee, ankle, or hip or indication of surgery throughout the intervention period","45 Years","65 Years",{"count":112,"type":21},44,[24],"This study seeks to compare these two interventions to better understand their impact on key health outcomes in patients affected by diabetic neuropathy, providing valuable insights for clinicians and healthcare providers managing this challenging condition",[46],"2026-05-04",{"date":118,"type":64},"2026-05-08",{"date":120,"type":21},"2026-05-15",{"date":122,"type":21},"2026-08-30",{"name":99,"class":100},{"id":125,"slug":126,"hasResults":11,"nctId":127,"briefTitle":128,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":131,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":134,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":101},"100615884","phase-1-cannabidiol-for-the-treatment-of-diabetic-peripheral-neuropathy-pilot-study-100615884","NCT07298408","Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot Study","CBD-DPN1","Inclusion Criteria\n\n1. Adult aged 40 to 70 years\n2. Diagnosis of Type 2 Diabetes\n3. Ambulatory and independently living adult\n4. Minimum body weight of 50 kg (to ensure daily dose ≤2 mg\u002Fkg)\n5. Physical exam completed within the previous 6 months\n6. Liver Function Studies (ALT and AST) completed within the previous six months showing normal values\n7. If NAFLD is present, ALT and AST levels are ≤2 times the Upper Limit of Normal (ULN)\n8. DN4 questionnaire results indicate mild to moderate DPN\n9. Nerve Conduction Test (NCT) confirms at least mild DPN\n10. Signed ICF\u002FScreening Consent\n11. Able to complete required questionnaires (adequate vision)\n\nExclusion Criteria:\n\n1. High-risk or severely ill individuals (e.g., high risk for general anesthesia, significant limitations due to heart\u002Flung disease, ascites, renal failure, loss of limbs from diabetic complications)\n2. Uncontrolled or severe cardiovascular disease (e.g., unstable angina, uncontrolled heart failure, recent myocardial infarction)\n3. History of atrial fibrillation, dysrhythmias, MI within the previous 2 years, or stroke\n4. Severe respiratory illness (e.g., uncontrolled asthma, COPD with frequent exacerbations, oxygen dependence)\n5. Severe or uncontrolled liver disease (e.g., cirrhosis, active viral hepatitis A, B, or C, autoimmune hepatitis, uncontrolled primary biliary cholangitis or primary sclerosing cholangitis)\n6. Elevation of liver enzymes (ALT or AST) exceeding 2 times the ULN, or bilirubin exceeding the ULN\n7. Severe or uncontrolled kidney disease (e.g., end-stage renal disease requiring dialysis, uncontrolled nephrotic syndrome)\n8. History of malignancy within the past 5 years (excluding certain low-risk non-melanoma skin cancers)\n9. History of a seizure disorder\n10. Blindness (poor vision preventing questionnaire completion)\n11. Known allergy or previous adverse reaction to any ingredient, including natural strawberry flavoring\n12. Reproductive Health (Women Only)\n13. Currently pregnant or lactating\n14. Women who can get pregnant who are not using acceptable methods of birth control\n15. Current uncontrolled mental health conditions (e.g., major depressive episode with active suicidal ideation, bipolar disorder with current manic\u002Fhypomanic episode, or psychosis)\n16. Diagnosis of a major depressive episode with active suicidal ideation and\u002For a plan to attempt suicide within the previous 5 years\n17. Attempted suicide in the last 10 years\n18. C-SSRS Suicide Ideation Subscore ≥5 at study onset\n19. HADS-D score ≥15 at study onset\n20. Used cannabis products in the past 30 days\n21. Current use or history of illicit drug use or misuse of prescription medications within the previous 5 years\n22. Heavy drinking (≥8 drinks\u002Fweek for women; ≥15 drinks\u002Fweek for men)\n23. Taking medications that are known to cross-reacting with CBD or Cannabiods","40 Years","70 Years",{"count":5,"type":21},[135,136],"PHASE1","PHASE2","The \"Cannabidiol for the Treatment of Diabetic Peripheral Neuropathy: Pilot study (CBD-DPN1)\" is a double-blinded, placebo-controlled, crossover pilot study evaluating the efficacy of Cannabidiol (CBD) and full-spectrum CBD (fsCBD) tinctures in treating Diabetic Peripheral Neuropathy (DPN)-associated pain. DPN is a common, highly distressing complication of diabetes, characterized by chronic pain and loss of sensory function, for which currently available treatments primarily offer only symptomatic relief. CBD and fsCBD are being investigated for their potential neuroprotective and analgesic effects by regulating inflammation and oxidative stress.\n\nThe study aims to recruit 12 to 20 adult participants who have mild to moderate DPN. Subjects will receive either an active treatment (CBD isolate or fsCBD in MCT oil, dosed at 50 mg twice daily for a total of 100 mg daily) or a placebo during two sequential 6-week phases. The overall objective of this pilot phase is primarily methodological: to test and refine the clinical protocol, assess patient compliance and acceptability of the CBD formulations, and generate sufficient data to calculate the necessary sample size for a larger, definitive study. Efficacy will be measured using objective and subjective metrics, including DPN severity (DN4 Assessment Tool and DPNCheck™ for nerve conduction velocity) and pain level (PainDetect Questionnaire). Secondary outcomes include evaluating mood (HADS), sleep quality (MOS Sleep Scale), and quality of life (EQ-5D-5L).",[139,46],"Diabetic Peripheral Neuropathic Pain (DPN)",[141,142,143,144,145,146],"Placebo","Pain Management","Quality of Life","Cross-Over Studies","Double-Blinded Placebo Contolled","Cannabidiol","2026-04-28",{"date":149,"type":64},"2026-04-29",{"date":151,"type":21},"2026-04-02",{"date":153,"type":21},"2027-06-30",{"name":155,"class":100},"Florida A&M University",{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":162,"eligibilityCriteria":163,"healthyVolunteers":164,"sex":17,"minAge":110,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":22,"phases":167,"briefSummary":168,"conditions":169,"keywords":174,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":101},"100573381","impact-of-screening-and-multicomponent-exercise-on-fall-rates-fractures-and-cardiovascular-health-in-diabetes-100573381","NCT06745544","Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes","Impact of Screening and Multicomponent Exercise on Fall Rates, Fractures, and Cardiovascular Health in Diabetes: Protocol for a Randomized Control Trial: DIACTIVE","DiaACTIVE","Inclusion Criteria:\n\n1. Men and women with either T1D or T2D with a minimum of 65 years of age with no upper limit.\n2. Living in their own home\n3. A diagnosis of diabetes at least one year prior to inclusion of the study to avoid honeymoon diabetes.\n4. Signed the informed consent.\n\nExclusion Criteria:\n\n1. No previous experience with rhythm-based multitask exercise.\n2. Having significant neurological diseases (e.g., Parkinson's and Multiple Sclerosis), vestibular diseases, or orthopedic surgeries (e.g., hip\u002Fknee replacement) affecting their ability to participate in the study.\n3. Having severely impaired cognitive function, defined as a score below 8 on the cognitive assessment \"the short orientation-memory-concentration test.\"\n4. Being fully dependent on walking aids.\n5. Pregnancy or breast feeding\n6. Active malignancy or terminally ill.\n7. Not being able to understand Danish written and\u002For verbally.\n8. Participating in other interventional clinical studies within the last six months\n9. People with a weekly exercise activity above 5 hours a week",true,{"count":166,"type":21},490,[24],"The DIACTIVE study is a randomized controlled trial with a 5- year follow-up designed to evaluate the impact of comprehensive screening and multicomponent interventions on fall prevention, bone health, nerve function and cardiovascular outcomes in people with diabetes aged 65 years and older on the short and longer term. Diabetes significantly increases risks of falls, fractures, and cardiovascular disease, yet these areas remain underexplored in clinical research. This trial addresses these gaps with a novel, multidimensional approach.\n\nParticipants undergo extensive baseline assessments, including fall risk stratification, bone mineral density measurements via DXA scans, neuropathy evaluations, and cardiovascular profiling. Based on these evaluations, participants are allocated to risk-based intervention arms. The study's centerpiece is the RYMA and ADL exercise program, a tailored cognitive-motor training regimen integrating strength, balance, and executive function exercises with music-based coordination tasks. Pharmacological treatments for osteoporosis and optimization of cardiovascular risk profiles (e.g., SGLT2 inhibitors, GLP-1 agonists) are also incorporated.\n\nPrimary outcomes focus on reducing fall rates by at least 30%, improving bone density, mitigating fracture risks, enhancing nerve function, and lowering cardiovascular event rates. Secondary endpoints explore mechanisms underlying fall reduction, quality of life improvements, and adherence to interventions. Advanced methodologies such as gait analysis, seismocardiography, and magnetic resonance imaging (MRI) provide detailed insights into the intervention's effects. Follow-ups at 26 weeks, 52 weeks, 2 years, and 5 years ensure long-term efficacy evaluation.\n\nThis trial is conducted at Steno Diabetes Center North and involves interdisciplinary collaboration. By addressing key complications of diabetes through integrated care, the study aims to improve patient outcomes and inform future healthcare strategies for older people with diabetes.",[170,171,46,172,173],"Type 2 Diabetes","Osteoporosis","Fall Prevention","Cardiovascular Diseases",[175,176,177,178,179,45,180,181,182,183],"Diabetes","T1D","T2D","RYMA","Falls","CVD","Diabetic Complications","Bone health","Fractures","2026-04-14",{"date":186,"type":64},"2026-04-17",{"date":188,"type":64},"2025-10-01",{"date":190,"type":21},"2027-12-31",{"name":192,"class":100},"Aalborg University Hospital",{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":201,"targetDuration":4,"studyType":22,"phases":203,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":101},"100625641","integrated-oral-care-intervention-for-xerostomia-in-diabetes-patients-100625641","NCT07425275","Integrated Oral Care Intervention for Xerostomia in Diabetes Patients","The Impact of Integrated Oral Care Intervention Provided by Endocrinologists on Oral Health and Well-being in Diabetes Patients","IOCID","Inclusion Criteria:\n\n* Presence of a single stone in the renal pelvis.\n* Age less than 18 years.\n* No congenital or acquired urinary tract abnormalities.\n* No pre-existing chest diseases (e.g., chronic lung disease, pleural effusion).\n\nExclusion Criteria:\n\n* Patients with multiple kidney stones.\n* Calyceal stones (stones located specifically in a calyx).\n* Pelviureteric junction obstruction (PUJO).\n* Pelvic kidney (renal ectopia).",{"count":202,"type":21},80,[24],"Diabetes patients commonly experience dry mouth also known as xerostomia which can affect eating speaking oral health and overall quality of life. This study evaluates whether simple oral care actions delivered by endocrinologists during routine diabetes clinic visits can improve dry mouth symptoms and oral health related quality of life. Endocrinologists will be trained to screen for dry mouth provide brief counseling prescribe saliva substitutes and refer patients to dental services when needed. Adult patients with diabetes and symptoms of dry mouth will be followed before and after the intervention to assess changes in xerostomia severity and oral health outcomes. The study will also explore barriers and facilitators to integrating oral health care into routine diabetes management in Pakistan.",[206,46],"Diabetes Mellitus",[208,209,210,211],"Diabetes mellitus","Oral health quality of life","Non communicable diseases","Integrated oral care","2026-02-16",{"date":214,"type":64},"2026-02-20",{"date":216,"type":64},"2026-02-01",{"date":218,"type":21},"2026-07-30",{"name":220,"class":100},"Khyber Medical University Peshawar",{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":229,"targetDuration":4,"studyType":22,"phases":231,"briefSummary":232,"conditions":233,"keywords":241,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":101},"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",{"count":230,"type":21},200,[24],"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.",[234,206,235,46,236,237,238,239,240],"Diabetic Foot","Peripheral Arterial Disease","Diabetic Retinopathy","Anemia","Ulcer Foot","Ulcer Ischemic","Diabetic Polyneuropathy",[242,243,244,245,246],"diabetic foot syndrome","peripheral artery disease","diabetic food ulcers","microbiome","percutaneous transluminal angioplasty","2026-02-03",{"date":249,"type":64},"2026-02-04",{"date":251,"type":64},"2024-02-01",{"date":253,"type":21},"2028-11-01",{"name":255,"class":100},"Heinrich-Heine University, Duesseldorf",{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":263,"enrollmentInfo":264,"targetDuration":4,"studyType":266,"phases":4,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":101},"100577429","neuropathic-pain-and-type-ii-diabetic-patients-100577429","NCT06798181","Neuropathic Pain and Type II Diabetic Patients","The Effect of Neuropathic Pain on Self-Care Ability and Quality of Life in Type II Diabetic Patients","Inclusion Criteria:\n\n* 18 years and older,\n* Diagnosed with type II diabetes,\n* Reading and writing,\n* No physical or psychological communication barriers,\n* Can read and speak Turkish,\n* Volunteers\n\nExclusion Criteria:\n\n* Diagnosed with type I diabetes","100 Years",{"count":265,"type":21},128,"OBSERVATIONAL","Diabetes Mellitus (DM) is a common metabolic disease characterized by hyperglycemia resulting from insufficiency, deficiency or absence of the insulin hormone. Chronic hyperglycemia, secondary metabolic and microvascular changes resulting in diabetic neuropathy are among the most common complications encountered in DM patients.\n\nDiabetic neuropathy is called peripheral, autonomic or spinal depending on the region of involvement. Peripheral involvement is more common than other region involvement and its prevalence in DM patients is observed to be 16-87%. Diabetic peripheral neuropathy (DPN) presents with numbness, tingling, paresthesia, muscle weakness and pain. These symptoms can start from the toes and progress to the leg and even the upper extremities.\n\nIn diabetic peripheral neuropathy, pain is seen as burning, electric shock or sharp cold pain, increases at night and affects sleep quality. In these patients, daily living activities such as walking, climbing stairs, and sleeping are negatively affected by progressive DPN and pain, falls are observed, mood disorders are experienced, and the quality of life decreases.",[269,143,46],"Neuropathic Pain","2025-12-29",{"date":272,"type":64},"2025-12-30",{"date":274,"type":64},"2024-12-15",{"date":276,"type":21},"2026-01-30",{"name":278,"class":100},"Bilecik Seyh Edebali Universitesi",{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":132,"enrollmentInfo":286,"targetDuration":4,"studyType":266,"phases":4,"briefSummary":288,"conditions":289,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":291,"lastUpdatePostDateStruct":292,"startDateStruct":294,"completionDateStruct":296,"leadSponsor":298,"locationsCount":101},"100553248","cross-cultural-adaptation-and-validity-of-the-arabic-translated-neuropathy-specific-quality-of-life-questionnaire-100553248","NCT06483620","Cross-cultural Adaptation and Validity of the Arabic-translated NEUROPATHY-SPECIFIC QUALITY OF LIFE Questionnaire","Neuropathy and Foot Ulcer_ Specific Quality of Life Instrument (Neuro QOL) Arabic Version: Cross-cultural Adaptation, Validity, and Reliability for Patients With Type 2 Diabetes","Inclusion Criteria:\n\n* Arabic is their first language The absence of any other neurological diagnosis affecting the sensory and motor system, such as stroke or multiple sclerosis\n* Age ranges between 18 and 70 years,\n* History of DM diagnosed by a physician and confirmed by either hemoglobin A1c ≥6.5% or the use of hypoglycemic agents.\n\nExclusion Criteria:\n\n* A hospital inpatient\n* Had pre-existing comorbidities such as cancer, shingles or other neuropathic pain entity that predated diabetes or can mimic or cause a neuropathic pain that is not arising as a result of diabetes.\n* Pregnant patients as diabetes may be of gestational type\n* Had recently experienced physical trauma that may have contributed to neuropathic pain had trauma or dermatological diseases of the skin as this could affect skin sensitivity (e.g. wounds, psoriasis and eczema).",{"count":287,"type":21},290,"PURPOSE: This study will translate, culturally adapt, validate, and test the reliability of the Neuro Qol Arabic version to be used with diabetic patients in Arabic countries.\n\nBackground: The Neuropathy- and Foot Ulcer-Specific Quality of Life instrument is a multidimensional scale was developed to assess the QoL of diabetic patients with peripheral neuropathy. Producing Arabic versions of the Translating Scale can help researchers investigate offloading treatment among the Arabic population with DFUs.\n\nHypotheses: The study design was a cross-cultural validation of NeuroQol, the Arabic version, for patients with DFUs.\n\nResearch Question: Will there be cultural adaptation, validation, and reliability between the (Neuro Qol) Arabic version and the original language?",[46,290],"Diabetic Peripheral Neuropathy","2025-10-02",{"date":293,"type":64},"2025-10-03",{"date":295,"type":64},"2025-02-13",{"date":297,"type":21},"2026-01-25",{"name":299,"class":100},"Cairo University",{"id":301,"slug":302,"hasResults":11,"nctId":303,"briefTitle":304,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":17,"minAge":306,"maxAge":18,"enrollmentInfo":307,"targetDuration":4,"studyType":266,"phases":4,"briefSummary":309,"conditions":310,"keywords":315,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":101},"100451542","early-detection-of-long-term-diabetic-complications-in-children-and-adolescents-with-type-1-diabetes-100451542","NCT05159856","Early Detection of Long-term Diabetic Complications in Children and Adolescents With Type 1 Diabetes","Inclusion Criteria:\n\n* T1D\\>12 months\n* 6-18 years old prior to inclusion\n* Followed at the Pediatric Diabetes outpatient clinic at Steno Diabetes Center Copenhagen\n* Speaks and reads Danish well enough to understanding the given oral and written information.\n* There is a written consent from the guardianship holder\u002Fholders for the child.\n\nExclusion Criteria:\n\n* T1D \\\u003C 12 months\n* Known cardiovascular disease\n* Antihypertensive treatment","6 Years",{"count":308,"type":21},400,"Aims: To investigate early markers of long-term diabetic complications and the association to an extended glucose metabolic profile comprising glucose control (current and past), glucose variability and insulin sensitivity in children and adolescents with type 1 diabetes (T1D).\n\nBackground: Most Danish children and adolescents with T1D do not achieve their metabolic target and are at increased risk of developing long-term diabetic complications, reducing their life expectancy and increase their morbidity rate. Hence, improved metabolic control, a better understanding of what optimal metabolic control means, combined with detailed monitoring of the first markers of long-term complications and their reversibility or lack thereof are needed.\n\nMethods: A prospectivel study of 400 children, aged 6-18 years old, with T1D\\>12 months. Early markers of long-term diabetic complications will be investigated as arterial stiffness, nerve dysfunction and nephropathy. Data on T1D onset, duration, treatment modality, self-monitoring-blood-glucose profiles, growth, weight, and pubertal status will be collected.\n\nBlood sampling will include routine tests and markers of glucose, lipid, bone, and gastrointestinal metabolism. DXA-scan, Fibroscan, bone-age, eye-examination and physical activity will be measured. Data on retrospective glucose- and lipid-profiles will be collected. The children will be offered a followup every 5 years for the next two decades.\n\nPerspectives: This study provides novel insight into the frequency of early markers of long-term diabetic complications and its association to the interplay of the pancreas, adipose, gastrointestinal and bone metabolic axis. Which can assist in identifying subgroups of children and adolescents requiring earlier in-depth screening for early markers of long-term diabetic complications, for putative interventions for prevention, hence reducing morbidity and mortality in T1D.",[311,312,313,46,314],"Diabetes Complications","type1diabetes","Children, Only","Arterial Stiffness",[316,317,318,319,320,321],"pediatric","arteriel stiffness","pulse wave velosity","neuropathy","type 1 diabetes","early diabetic complications","2025-05-28",{"date":324,"type":64},"2025-06-03",{"date":326,"type":64},"2022-05-03",{"date":328,"type":21},"2025-12",{"name":330,"class":100},"Steno Diabetes Center Copenhagen",{"id":332,"slug":333,"hasResults":11,"nctId":334,"briefTitle":335,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":11,"sex":17,"minAge":131,"maxAge":4,"enrollmentInfo":338,"targetDuration":4,"studyType":22,"phases":340,"briefSummary":341,"conditions":342,"keywords":344,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":356},"100585723","phase-2-finerenone-treatment-for-diabetic-cardiovascular-autonomic-neuropathy-the-fibrocan-study-100585723","NCT06906081","Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study","FibroCAN","To be included in this study the participants must fulfill the following inclusion criteria.\n\n* Given informed consent\n* Type 2 diabetes defined by WHO criteria\n* Aged 40 ≥ at inclusion\n* Pathological E\u002FI ratio (Mean value of three measures)\n\nExclusion criteria Participants will be excluded in one or more of the following criteria are met.\n\n* No CAN (no abnormal CARTs)\n* Definite CAN (more than one abnormal CART)\n* HbA1C \\>100 mmol\u002FL\n* Treatment with potassium-sparing diuretics (amiloride) or MRAs e.g., spironolactone or eplerenone which cannot be discontinued 4 weeks prior to screening visit. The patient's primary physician, who is not involved in this study, will determine if discontinuation is possible.\n* Atrial fibrillation\u002Fflutter\n* Congestive heart failure (NYHA class 3-4)\n* History of cardiac arrhythmia\n* Severe forms of respiratory disease including asthma and COPD\n* Any nondiabetic cause of neuropathy\n* All female subjects of childbearing potential (WOCBP) must have a negative result of a highly sensitive urine HCG (pregnancy test) performed at screening. Subjects of childbearing potential must agree to use a highly effective form of contraception throughout the duration of the study (list of definition on WOCBP and accepted contraception in appendix A).\n* Severe hepatic impairment\n* Lactose intolerance\n* Breastfeeding\n* Nephropathy requiring dialysis\n* Beta-blocker-use\n* Hyperkalemia at screening visit (plasma potassium \\>4.8 mmol\u002Fl)\n* eGFR \\\u003C 25 ml\u002Fmin\u002F1.73m2\n* Potassium plasma \\> 4.8 mmol\u002Fl (at randomization)\n* Treatment with strong CYP3A4-inhibitors (e.g. Itraconazol, ketoconazol, ritonavir, cobicistat, clarithromycin) which cannot be discontinued 4 weeks prior to screening visit\n* Treament with moderate to strong CYP3A4-induceres (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, St John's Wort or efavirenz) which cannot be discontinued 4 weeks prior to screening visit\n* Have received chemotherapeutic treatment within last 12 months\n* Grapefruit consumption that cannot be discontinued during the study period\n* Inability to complete study protocol, assessed to investigator\n* Not able to read, write and\u002For understand Danish",{"count":339,"type":21},100,[136],"Diabetic neuropathy is a serious and common complication of diabetes that currently has no cure. One form of this condition is cardiovascular autonomic neuropathy (CAN), which affects about 20% of people with diabetes-an estimated 100 million people worldwide. CAN is a significant risk factor for death and health problems like heart disease and kidney damage, and may contribute to the high rates of cardiovascular-related deaths in people with diabetes.\n\nThis study is a double-blind, randomized, placebo-controlled, two-center trial. The study aims to test whether finerenone can treat cardiovascular autonomic neuropathy in patients with type 2 diabetes. The trial will evaluate the effects of 78 weeks of treatment with finerenone or a placebo, assigned randomly in a 1:1 ratio, on early-stage cardiovascular autonomic neuropathy. The trial will include 100 participants with type 2 diabetes. Additionally, the study will investigate how the treatment impacts other types of neuropathy and related pathological mechanisms.",[343,170,46],"Cardiovascular Autonomic Neuropathy",[345,346,170,58],"Mineralocorticoid receptor antagonist (MRA)","Cardiovascular autonomic neuropathy","2025-05-23",{"date":349,"type":64},"2025-05-25",{"date":351,"type":64},"2025-05-02",{"date":353,"type":21},"2028-01",{"name":355,"class":100},"Peter Rossing",2,{"id":358,"slug":359,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":365,"enrollmentInfo":366,"targetDuration":4,"studyType":22,"phases":368,"briefSummary":369,"conditions":370,"keywords":377,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":356},"100331368","additional-hyperbaric-oxygen-after-lower-extremity-amputation-100331368","NCT03594344","Additional Hyperbaric Oxygen After Lower Extremity Amputation","Additional Hyperbaric Oxygen After Lower Extremity Amputation - A Randomized Controlled Trial","AHOLEA","Inclusion Criteria:\n\n* Lower extremity amputation because of chronic wound, osteomyelitis, ischemia, necrosis.\n* Fit to receive hyperbaric oxygen therapy determined by an anesthesiologist\u002FHyperbaric Medicine Physician.\n* Able to cooperate and follow up appointments\n* Included within 7 days after final surgery\n\nExclusion Criteria:\n\n* Not fulfilling inclusion criteria\n* Pregnancy\n* Dementia","90 Years",{"count":367,"type":21},120,[24],"This study evaluates the effect of additional hyperbaric oxygen therapy after lower extremity amputation. The patients will be randomized after amputation to either a treatment group receiving hyperbaric oxygen therapy, or control group.",[206,371,372,373,374,375,376,46,234],"Claudication, Intermittent","Critical Limb Ischemia","Osteomyelitis","Amputation","Lower Extremity Ulcer","Diabetic Angiopathy",[378,175,379,380,381],"Diabetic foot","Lower extremity amputation","Hyperbaric oxygen therapy","HBOT","2025-03-25",{"date":384,"type":64},"2025-03-30",{"date":386,"type":64},"2018-07-04",{"date":388,"type":21},"2026-12-31",{"name":390,"class":100},"Oslo University Hospital",{"id":392,"slug":393,"hasResults":11,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":397,"eligibilityCriteria":398,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":22,"phases":401,"briefSummary":402,"conditions":403,"keywords":418,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":428,"leadSponsor":430,"locationsCount":101},"100567960","clinical-trial-assessing-human-placental-membrane-products-and-standard-of-care-versus-standard-of-care-in-nonhealing-dfus-and-vlus-100567960","NCT06674980","Clinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs","A Multicenter, Prospective, Randomized Controlled Modified Platform Trial Assessing the Efficacy of Human Placental Membrane Products and Standard of Care Versus Standard of Care Alone in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers.","C5CAMP","Inclusion Criteria for DFU:\n\n1. At least 18 years of age or older.\n2. Must have diagnosis of type 1 or 2 Diabetes mellitus.\n3. At enrollment, subject must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20.0 cm2 measured post debridement with the imaging device.\n4. Must have a target ulcer that has been present for a minimum of 4 weeks and maximum of 52 weeks of standard of care, prior to screening visit.\n5. Target ulcer located on the foot with at least 50% of the ulcer below the malleolus.\n6. Target ulcer that is Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include exposed tendon or bone.\n7. Subject's affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n   1. ABI between 0.7 and \\\u003C= 1.3\n   2. TBI \\>= 0.6\n   3. TCOM \\>= 40 mmHg\n   4. PVR: biphasic\n8. If subject has two or more ulcers, they must be separated by 2 cm. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n9. Target ulcer must be located on the plantar aspect of the foot and must be offloaded for at least 14 days prior to enrollment.\n10. Subject must consent to using the prescribed offloading method for the duration of the study.\n11. Subject must agree to attend weekly study visits.\n12. Subject must be willing and able to participate in the consent process.\n\nExclusion Criteria for DFU:\n\n1. Subject is known to have a life expectancy of \\\u003C 6 months.\n2. Subject's target ulcer is not secondary to diabetes.\n3. Target ulcer is infected or there is cellulitis in the surrounding skin.\n4. Target ulcer exposes tendon or bone.\n5. Evidence of osteomyelitis complicating the target ulcer.\n6. Infection in the target ulcer or in a remote location that requires systemic antibiotic therapy.\n7. The subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n8. Subject is taking hydroxyurea.\n9. Subject has applied topical steroids to the ulcer surface within one month of initial screening.\n10. Subject has a previous partial amputation on the affected foot that results in a deformity that impedes proper offloading of the target ulcer.\n11. Subject has a glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n12. The surface area of the subject's target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit (\"historical\" run-in period). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).\n13. The surface area measurement of the subject's target ulcer decreases by 20% or more during the active 2-week screening phase.\n14. Subject has acute Charcot foot, or an inactive Charcot foot, which impedes proper offloading of the target ulcer.\n15. Subject is a woman who is pregnant or considering becoming pregnant in the next 6 months.\n16. Subject has end stage renal disease requiring dialysis.\n17. Subject has participated in a clinical trial involving treatment with an investigational product within the previous 30 days.\n18. The subject, in opinion of the Investigator, has a medical or psychological condition that may interfere with study assessments.\n19. Subject was treated with hyperbaric oxygen therapy or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to screening.\n20. Subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n\nInclusion Criteria for VLU:\n\nPotential subjects are required to meet all the following criteria for enrollment in the study.\n\n1. Subjects must be at least 18 years of age or older.\n2. At randomization subjects must have a target ulcer with a minimum surface area of 0.7 cm2 and a maximum surface area of 20 cm2 measured post-debridement.\n3. The target ulcer must have been present for a minimum of 4 weeks and a maximum of 52 weeks of standard of care prior to the initial screening visit.\n4. No visible signs of healing objectively, less than 40% reduction in wound size in the last 4 weeks.\n5. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable:\n\n   1. ABI between 0.7 and ≤ 1.3;\n   2. TBI ≥ 0.6;\n   3. TCOM ≥ 40 mmHg;\n   4. PVR: biphasic.\n6. If the potential subject has two or more ulcers, they must be separated by at least 2 cm post-debridement. The largest ulcer satisfying the inclusion and exclusion criteria will be designated as the target ulcer.\n7. The potential subject must agree to attend the weekly study visits required by the protocol.\n8. The potential subject must be willing and able to participate in the informed consent process.\n\nExclusion Criteria for VLU:\n\n1. The potential subject is known to have a life expectancy of \\\u003C 6 months.\n2. The target ulcer is infected, requires systemic antibiotic therapy, or there is cellulitis in the surrounding skin.\n3. The target ulcer exposes tendon or bone.\n4. There is evidence of osteomyelitis complicating the target ulcer.\n5. The potential subject is receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of prednisone per day or equivalent) or cytotoxic chemotherapy or is taking medications that the PI believes will interfere with wound healing (e.g., biologics).\n6. The potential subject has applied topical steroids to the ulcer surface within one month of initial screening.\n7. The potential subject has glycated hemoglobin (HbA1c) greater than or equal to 12% within 3 months of the initial screening visit.\n8. The surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to the initial screening visit (\"historical\" run-in period). Imaging Device is not required for measurements taken during the historical run-in period (e.g., calculating surface area using length X width is acceptable).\n9. The surface area measurement of the target ulcer decreases by 20% or more during the active 2-week screening phase: the 2 weeks from the initial screening visit (SV-1) to the TV-1 visit during which time the potential subject received SOC.\n10. Women who are pregnant or considering becoming pregnant within the next 6 months.\n11. The potential subject has end stage renal disease requiring dialysis.\n12. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.\n13. A potential subject who, in the opinion of the investigator, has a medical or psychological condition that may interfere with study assessments.\n14. The potential subject was treated with hyperbaric oxygen therapy (HBOT) or a Cellular, Acellular, Matrix-like Product (CAMP) in the 30 days prior to the initial screening visit.\n15. The subject has a malnutrition indicator score \\\u003C17 as measured on the Mini Nutritional Assessment.\n16. A subject has a wound with active or latent infection is excluded.\n17. A subject with a disorder that would create unacceptable risk of post-operative complications is excluded.",{"count":400,"type":21},177,[24],"The purpose of the study is to evaluate the efficacy of multiple human placental membrane products and Standard of Care (SOC) versus SOC alone in the management of nonhealing diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) over 12 weeks using a modified platform trial design.",[404,206,405,406,407,408,409,173,410,411,412,311,46,413,234,414,415,416,417],"Pathologic Processes","Glucose Metabolism Disorders","Metabolic Diseases","Endocrine System Disease","Diabetic Angiopathies","Vascular Diseases","Leg Ulcer","Skin Ulcer","Skin Diseases","Foot Diseases","Foot Ulcer","Diabetes Mellitus, Type 2","Ulcer","Foot Ulcer Unhealed",[419,420,421,422,423],"Human Placental Membrane (HPM)","Diabetic Foot Ulcer (DFU)","Venous Leg Ulcer (VLU)","Cellular, Acellular, and Matrix-like Product (CAMP)","Cellular and\u002For Tissue-Based Product (CTP)","2024-12-20",{"date":426,"type":64},"2024-12-27",{"date":424,"type":64},{"date":429,"type":21},"2027-01-22",{"name":431,"class":71},"C5 Biomedical",{"id":433,"slug":434,"hasResults":11,"nctId":435,"briefTitle":436,"officialTitle":436,"acronym":437,"eligibilityCriteria":438,"healthyVolunteers":164,"sex":17,"minAge":18,"maxAge":439,"enrollmentInfo":440,"targetDuration":4,"studyType":22,"phases":442,"briefSummary":443,"conditions":444,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":101},"100476429","multisensory-stimulation-to-target-sensory-loss-and-chronic-pain-in-neuropathic-patients-100476429","NCT05483816","MultiSENSory Stimulation to TArgeT Sensory Loss and ChronIc Pain in NeurOpathic PatieNts","SENSATION","for healthy:\n\n* Inclusion:\n\n  * Age 18-80\n  * Visual acuity\\>6 on Snellen visual acuity chart\n* Exclusion:\n\n  * Pregnancy\n  * Cognitive deficits (Mini Mental State Examination\\<23)\n  * Cyber-sickness\n  * Prior or current psychological diseases\n  * Pacemakers\n  * Epilepsy\n  * Claustrophobia\n  * Other MRI contraindications\n  * Unhealed fractures\n  * Unhealed wounds\n  * Cancerous growth in proximity to feet\n  * Swollen, infected or inflamed areas on feet or skin eruptions on feet such as phlebitis, thrombophlebitis or varicose veins\n\nfor patients:\n\n* Inclusion:\n\n  * Age 18-80\n  * Visual acuity\\>6 on Snellen visual acuity chart\n  * Diagnosis of peripheral neuropathy\n  * Pain in lower limbs\\>=3 cm on VAS scale\n* Exclusion:\n\n  * Pregnancy\n  * Relevant comorbidities that would affect the outcomes of the study (by judgement of physicians)\n  * Ulcers\n  * Cognitive deficits (Mini Mental State Examination\\<23)\n  * Cyber-sickness\n  * Prior or current psychological diseases\n  * Pacemakers\n  * Epilepsy\n  * Claustrophobia\n  * Other MRI contraindications\n  * Unhealed fractures\n  * Unhealed wounds\n  * Cancerous growth in proximity to feet","80 Years",{"count":441,"type":21},40,[24],"Neuropathy is a costly and disabling health issue, which consists of a degeneration of the peripheral nerves. Even though the causes may be different, such as diabetes or amputation, the consequences for neuropathic patients are multiple and extremely debilitating. Among the alarming symptoms it implicates, chronic pain and sensory loss are among the most severe ones. Because of the loss of sensations, patients are forced to have an altered gait strategy, an impaired balance and a fivefold increased risk of falling. Furthermore, since they lose sensations and feel numbness in their extremity, they are discouraged in walking, hence leading to a sedentary lifestyle. All of this is worsened by the development of neuropathic pain, which has a high comorbidity with psychological issues, such as depression and anxiety.\n\nToday, proper treatments for neuropathic pain that exclude pharmacological solutions are still missing. This is due to the complexity of the neurobiological mechanisms underlying the origin of neuropathy, the multifaceted physical and psychological nature of pain and the lack of reliable biomarkers.\n\nThe aim of this project is to tackle the major problems connected to neuropathy thanks to non-invasive stimulation of the peripheral nervous system. The system is composed of an insole with pressure sensors that captures in real time the force exerted by the subject on the foot and couples this information with parameters of electrical stimulation. Thanks to optimal electrode placement and intensity modulation, subjects are able to perceive in real-time in a somatotopic manner (i.e., under their foot) how they are walking. The aim now is twofold: first the investigators want to couple this stimulation with Virtual Reality (VR) to develop a neuroadaptive non-invasive brain computer interface (BCI) to treat pain and secondly the investigators want to measure through fMRI scans whether the use of the sensory feedback system allows any beneficial plastic changes in the brain. Finally, the investigators want to measure through fMRI scans whether the use of the sensory feedback system allows any beneficial plastic changes in the brain.",[45,445,446,46,374],"Neuropathy, Painful","Sensory Neuropathy","2024-11-14",{"date":449,"type":64},"2024-11-18",{"date":451,"type":64},"2022-06-30",{"date":453,"type":21},"2028-02-28",{"name":455,"class":100},"ETH Zurich",{"id":457,"slug":458,"hasResults":11,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":11,"sex":17,"minAge":463,"maxAge":110,"enrollmentInfo":464,"targetDuration":4,"studyType":22,"phases":466,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":475,"locationsCount":101},"100567610","digital-heath-integration-with-neuromodulation-therapies-on-diabetic-neuropathy-100567610","NCT06670430","Digital Heath Integration With Neuromodulation Therapies on Diabetic Neuropathy","Digital Heath Integration With Neuromodulation Therapies on Sensory and Motor Function in Patients With Diabetic Neuropathy","Inclusion Criteria:\n\n* 1\\. Diagnosis of diabetes based on World Health Organization (WHO) with ages from 55to 65years 2. BMI\\> 25kg\u002Fm2 3. Clinically diagnosed with diabetic neuropathy. 4. All patients are taking oral hypoglycemic drugs with controlled diabetes mellitus.\n\n  5\\. Willingness to comply with the study procedures and interventions. 6. Ability to provide informed consent. 7. presenting with Distal symmetric polyneuropathy (DSPN) based on a score of ≥7 on the validated Michigan Neuropathy Screening Instrument (MNSI) questionnaire.\n\n  8\\. exhibiting moderately controlled blood pressure\n\nExclusion Criteria:\n\n* 1\\. Presence of other significant neurological or musculoskeletal disorders that may confound the assessment of outcomes.\n\n  2\\. Severe cognitive impairment or inability to provide informed consent. 3. Any recent surgical procedures or major medical events that could affect the study outcomes.\n\n  4\\. Fracture. 5. Heart Failure. 6. Uncooperative patients. 7. Anemic patient. 8. Patients with liver diseases. 9. Smokers Patients. 10. Any cardiac pacemaker, automatic implantable cardioverter defibrillator (AICD), or other implanted electrical device 11. An existing deep vein thrombosis (DVT) 12. Any metal implants 13. Current foot ulceration or other lower limb skin ulcers 14. Any other cause of neuropathy","55 Years",{"count":465,"type":21},60,[24],"This study will be carried out on 60 patients both gender male and female with diabetic neuropathy with age55-65 years. The patients will be selected from Elmahmoudia hospital .patients will be randomly assigned to two groups.",[46],"2024-10-31",{"date":471,"type":64},"2024-11-01",{"date":473,"type":21},"2024-11-10",{"date":272,"type":21},{"name":299,"class":100},{"id":477,"slug":478,"hasResults":11,"nctId":479,"briefTitle":480,"officialTitle":480,"acronym":4,"eligibilityCriteria":481,"healthyVolunteers":164,"sex":17,"minAge":131,"maxAge":439,"enrollmentInfo":482,"targetDuration":483,"studyType":266,"phases":4,"briefSummary":484,"conditions":485,"keywords":486,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":101},"100553382","use-of-thermography-for-the-prevention-and-diagnosis-of-diabetic-foot-100553382","NCT06485362","Use of Thermography for the Prevention and Diagnosis of Diabetic Foot","Inclusion Criteria:\n\nSubjects of both sexes. Age between 40 and 80 years. Diagnosis of type 1 or type 2 diabetes mellitus (for the case group). Absence of acute inflammatory diseases in the control group. Signed informed consent.\n\nExclusion Criteria:\n\nSkin diseases that affect the interpretation of thermography. Recent treatment with medications that affect peripheral circulation. History of lower limb amputation.",{"count":339,"type":21},"1 Year","Diabetic foot is a serious complication of diabetes mellitus that can lead to ulcerations, infections and, in extreme cases, amputations. Early detection of changes in skin temperature can help prevent these complications. Infrared thermography is a noninvasive technique that allows the visualization and quantification of skin temperature and could be an effective tool for the early detection of alterations in diabetic foot.\n\nObjective\n\nTo evaluate the effectiveness of infrared thermography in the early detection and diagnosis of diabetic foot, comparing the temperatures of the feet of healthy subjects and subjects with diabetic foot.",[234,46,376],[487,488,489,490],"diabetic foot","neuropaty","angiopaty","termography","2024-06-28",{"date":493,"type":64},"2024-07-03",{"date":495,"type":21},"2024-09-01",{"date":497,"type":21},"2026-09-01",{"name":499,"class":100},"University of Seville",{"id":501,"slug":502,"hasResults":11,"nctId":503,"briefTitle":504,"officialTitle":505,"acronym":4,"eligibilityCriteria":506,"healthyVolunteers":11,"sex":17,"minAge":507,"maxAge":508,"enrollmentInfo":509,"targetDuration":4,"studyType":22,"phases":511,"briefSummary":512,"conditions":513,"keywords":514,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":518,"completionDateStruct":519,"leadSponsor":521,"locationsCount":101},"100552937","us--hilt-comparative-effect-on-neuropathic-pain-strength--qof-in-diabetic-foot-100552937","NCT06479577","US & HILT Comparative Effect on Neuropathic Pain, Strength & QOF in Diabetic Foot","Comparative Effects of Therapeutic Ultrasound and High Intensity Laser Therapy on Neuropathic Pain ,Strength and Quality of Life in Diabetic Foot","Inclusion Criteria:\n\n* Patients with type 2 diabetes.\n* Diabetic Patients of age 50 to 75 years.\n* Diabetic patient of Both genders\n* Diagnosed Diabetes Mellitus with at least 7 years of duration\n* Distal symmetrical or asymmetrical polyneuropathy with pain in the lower extremity for ≥6 months\n* DNS (Diabetic neuropathy symptoms questionnaire) score greater than 4 (90 percent probability of neuropath\n\nExclusion Criteria:\n\n* Pregnant females\n* Lower limb Amputated patients\n* History or evidence of neurological disorders other than peripheral neuropathy associated with Diabetes mellitus.\n\n  * Evidence of musculoskeletal dysfunctions like scoliosis, lumbar disc prolapses and lumbar spine associated radiculopathy.\n  * History of any low back surgeries and lower limb surgeries\n* Patient with malignancy. Patient with epilepsy\n* Patient with hemophilia\n* Patient with pacemaker, metal implants prosthesis and internal fixation screws.\n* Patient with severe cervical and lumbar neuropathy, rheumatoid arthritis, hereditary neuropathy\n* Patient with a history of neurosurgery","50 Years","75 Years",{"count":510,"type":21},46,[24],"To compare the effects of therapeutic ultrasound and high intensity laser therapy on neuropathic pain , strength and quality of life in patients with diabetic foot",[234,46],[515],"diabetic neuropathies","2024-06-24",{"date":491,"type":64},{"date":251,"type":64},{"date":520,"type":21},"2024-07-01",{"name":99,"class":100},{"id":523,"slug":524,"hasResults":11,"nctId":525,"briefTitle":526,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":22,"phases":530,"briefSummary":531,"conditions":532,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":542,"locationsCount":101},"100536407","phenotypic-and-genotypic-characterization-of-patients-with-dysmetabolism-in-greenland-100536407","NCT06264427","Phenotypic and Genotypic Characterization of Patients With Dysmetabolism in Greenland","Inclusion Criteria:\n\n* Type 2 diabetes and\u002For morbid obesity (BMI \\>40)\n* Over 18 years old\n\nExclusion Criteria:\n\n* Does not speak either English, Danish or Greenlandic",{"count":529,"type":21},1000,[24],"The goal of this clinical trial is to perform a detailed description of the feno- and genotype of people living with type 2 diabetes and severe obesity who are linked to care at Steno Diabetes Center Greenland.\n\nThe main questions it aims to answer are:\n\n* Are monogenetic diabetes variants associated with the same risk of developing late diabetic complications as other types of diabetes?\n* Can genotyping and thereby personalized medicine be implemented in Greenland, and can personalized medicine lead to improved treatment?\n* What is the prevalence of sleep apnea among high-risk individuals in Greenland?\n* Is it possible to develop and implement a simple algorithm for the identification of sleep apnea in Greenland that can ensure treatment of severe sleep apnea?\n\nParticipants will:\n\n* Answer WHO-5 and FOSQ-10 questionnaires regarding quality of life and functional outcomes of sleepiness\n* Perform VAGUS examinations for Cardiovasculare Autonomic Neuropathy\n* Clinical examination of height, weight, circumference of hip, waist and neck, Friedman tonsil and tongue score, nasal air flow, nasal septal deviation\n* Blood samples for full genome sequencing",[415,533,534,535,236,46],"Obesity, Morbid","Obstructive Sleep Apnea","MODY","2024-02-15",{"date":538,"type":64},"2024-02-20",{"date":540,"type":64},"2022-07-15",{"date":388,"type":21},{"name":543,"class":100},"Steno Diabetes Center Greenland",{"id":545,"slug":546,"hasResults":11,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":4,"eligibilityCriteria":550,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":551,"targetDuration":4,"studyType":266,"phases":4,"briefSummary":552,"conditions":553,"keywords":555,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":4},"100474697","determining-patterns-in-trial-experiences-of-diabetic-neuropathy-patients-100474697","NCT05461274","Determining Patterns In Trial Experiences of Diabetic Neuropathy Patients","An In Depth Study Examining Patterns in the Clinical Trial Experiences of Diabetic Neuropathy Patients","Inclusion Criteria:\n\n* Patient plans to participate in an interventional clinical trial for the condition of diabetic neuropathy\n* Patient has been diagnosed with a type of diabetic neuropathy\n* Patient is a minimum of 18 years of age\n* Patient has access to a home internet connection in order to provide regular updates through the course of the study\n\nExclusion Criteria:\n\n* Patient is not able to provide consistent digital updates as per study requirements\n* Patient does not complete or agree to terms outlined in the Informed Consent Form\n* Patient has an ECOG score of 4 or higher",{"count":20,"type":21},"Historically, participation in clinical studies is highly skewed towards particular demographic groups of people.\n\nThis study will invite several participants to gather a wide range of information on clinical trial experiences for diabetic neuropathy patients. The aim of the study is to identify the factors that limit the ability of a person to enroll in, as well as complete a clinical trial for treatment of diabetic neuropathy.\n\nThe data collected from this study will help improve future outcomes for all diabetic neuropathy patients as well as those in under-represented demographic groups.",[46,554],"Diabetic Neuropathy Peripheral",[556,319],"diabetic neuropathy","2023-12-29",{"date":559,"type":64},"2024-01-02",{"date":561,"type":21},"2024-08",{"date":563,"type":21},"2026-08",{"name":565,"class":71},"Power Life Sciences Inc.",{"id":567,"slug":568,"hasResults":11,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":572,"eligibilityCriteria":573,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":132,"enrollmentInfo":574,"targetDuration":4,"studyType":22,"phases":576,"briefSummary":577,"conditions":578,"keywords":580,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":101},"100512348","quantifying-artificial-pancreas-related-changes-in-diabetic-neuropathy-100512348","NCT05951283","Quantifying Artificial Pancreas-related Changes in Diabetic Neuropathy","A Longitudinal, Single Centre Study to Assess the Effects of Artificial Pancreas-related Changes in Diabetic Neuropathy","QUANT-AP","Inclusion Criteria:\n\nType 1 diabetes aged 18-70 who falls into either of these three categories and has the ability to read and comprehend English:\n\nStarting Artificial Pancreas therapy as determined for clinical need Starting insulin pump therapy as determined for clinical need On multiple daily injection therapy for insulin delivery\n\nExclusion Criteria:\n\n* History of ocular disease that may affect the cornea.\n* History of corneal trauma or surgery (NB cataract surgery does not preclude enrolment unless surgery occurred in the 3 months prior to enrolment date)\n* Concurrent ocular disease, infection or inflammation.\n* History of neuropathy due to alcoholism, renal impairment requiring renal replacement therapy, infectious disease (e.g., Lyme disease, HIV\u002FAIDS, hepatitis B), liver failure, B12 deficiency\n* Unable to read and comprehend English",{"count":575,"type":21},102,[24],"A complication of diabetes mellitus is damage to nerves called neuropathy. There are several mechanisms involved that will lead to the development of neuropathy. Neuropathy can lead to foot ulcers, infections and amputations. Patients with neuropathy may also experience pain, which can be difficult to control and the medications are limited by side effects. Despite this there are no approved treatments to reverse the progression of neuropathy and the management of patients is focused on controlling blood glucose and other metabolic factors to prevent neuropathy and its symptoms from getting worse.\n\nPatients with type 1 diabetes are prescribed multiple daily injections (MDI) of insulin to manage their glucose control. However, insulin pump therapy and, more recently, automated insulin delivery (AID) or the Artificial Pancreas can be used as the insulin delivery method for patients with type 1 diabetes mellitus. Manchester Diabetes Centre is the first adult diabetes centre in Europe to pioneer and use a commercially-approved AID in clinical practice.\n\nInsulin pump therapy and AID have the advantage of being able to provide insulin at variable doses, which is closer to the natural process occurring within an individual without diabetes. Both are currently considered to be the most physiological method of insulin delivery and have been shown to improve glycaemic control, quality of life (QOL) and reduce the risk of hypoglycaemia (low blood glucose level). The investigators have previously shown in a small group of people that use of an insulin pump therapy may improve symptoms of painful neuropathy via a more stable glucose profile. The peaks and drops in insulin may make neuropathy worse.\n\nIn this study the investigators aim to investigate the use of insulin pump therapy and AID in their effect on neuropathy. This will be in comparison to a control group of patients on MDI. The investigatorsbwill use a variety of neuropathy measures and symptom questionnaires to assess structural and functional neuropathy status. The investigators hypothesise that those patients receiving the newer technologies will demonstrate an improvement in symptoms and nerve regeneration.\n\nThis finding would have a significant impact for patients as it would provide evidence to suggest that those patients with neuropathy should be put onto an insulin pump or AID to improve neuropathy and its symptoms. As these are treatments that are already available on the NHS to patients satisfying specific criteria this study aims to show benefit in this cohort of patients which can be implemented immediately in clinical practice.",[311,579,46],"Diabetes Mellitus, Type 1",[175],"2023-10-27",{"date":583,"type":64},"2023-10-30",{"date":585,"type":21},"2023-12-01",{"date":587,"type":21},"2026-07-01",{"name":589,"class":590},"Manchester University NHS Foundation Trust","OTHER_GOV"]