[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diabete-mellitus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diabete-mellitus":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,46,0,25,[9,42,67,106,132,161,183,211,234,259,289,315,342,368,398,422,447,469,494,519,543,577,602,625,642],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100652412","effectiveness-and-utility-of-telemonitoring-in-improving-the-glycaemic-control-of-diabetes-mellitus-tunisian-patients-100652412",false,"NCT07774078","Effectiveness and Utility of Telemonitoring in Improving the Glycaemic Control of Diabetes Mellitus Tunisian Patients","Evaluation of the Effectiveness and Utility of Telemonitoring in Improving the Glycaemic Control of Tunisian Patients With Diabetes Mellitus: a Study Protocol","Inclusion Criteria:\n\n* Diagnosis of diabetes mellitus with HbA1c between 7% and 10%.\n* Stable antidiabetic treatment for at least 4 weeks prior to enrollment.\n\nExclusion Criteria:\n\n* Serum creatinine \\>200 µmol\u002FL.\n* Acute coronary syndrome or stroke.\n* Dementia.\n* Pregnancy.\n* Inability to participate in or comply with the telemonitoring intervention.\n* Severe diabetic retinopathy.","ALL","18 Years",{"count":20,"type":21},260,"ESTIMATED","INTERVENTIONAL",[24],"NA","The study aims to evaluate the impact of a telemonitoring system on glycemic control in patients with diabetes in Tunisia. Participants in the intervention group will receive remote diabetes management through a dedicated mobile application and web platform, while the control group will receive standard diabetes care. The primary objective is to determine the effectiveness of telemonitoring in improving glycemic control, as assessed by changes in glycated hemoglobin (HbA1c) and blood glucose levels.",[27,28],"Diabete Mellitus","Telemonitoring","RECRUITING","2026-08-19",{"date":32,"type":33},"2026-08-20","ACTUAL",{"date":35,"type":33},"2024-08-01",{"date":37,"type":21},"2026-12-31",{"name":39,"class":40},"University of Monastir","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":51,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":41},"100652322","cardiovascular-kidney-metabolic-ckm-guided-therapy-for-patients-after-acute-coronary-syndrome-100652322","NCT07773272","Cardiovascular-kidney-metabolic (CKM)-Guided Therapy for Patients After Acute Coronary Syndrome","SLIM-3","Inclusion Criteria:\n\n* Age \\> 18 years\n* Hospitalised with acute coronary syndrome\n* Underwent percutaneous coronary intervention\n\nExclusion Criteria:\n\n* Acute coronary syndrome secondary to other diseases\n* Life expectancy \\\u003C 1 year based on the clinician's expertise",{"count":50,"type":21},1215,"2 Years","OBSERVATIONAL","Patients with a history of myocardial infarction are at significantly increased risk of recurrent cardiovascular events. Despite established clinical guidelines, secondary preventive care is often initiated too late, inadequate in intensity or incomplete in application. As a result, important opportunities to prevent serious outcomes are missed.\n\nThe aim of this project is to investigate whether rapid, guideline-based treatment following myocardial infarction leads to improved patient outcomes. The study protocol is based on current clinical guidelines and targets key domains including diabetes, hypertension, and hypercholesterolemia. Outcomes of patients treated according to the study protocol will be compared to those receiving standard care. Primary endpoints include major adverse cardiac- and cerebrovascular events within a 24-month follow-up period.\n\nThe investigators hypothesize that rapid, guideline-based intervention will result in improved risk factor management, leading to a reduction in cardiovascular events and mortality. For patients, this may translate into improved health, quality of life and life expectancy. This project aims to deliver a practical protocol for effective secondary prevention in clinical practice, which is expected to reduce healthcare utilization in the long term. With this initiative, the investigators seek to take a significant step toward improving post-myocardial infarction care and contributing to sustainable cardiovascular healthcare.",[55,56,57,27,58],"Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)","Hypercholerolemia","Hypertension","Cardiovascular Risk Management","2026-08-18",{"date":30,"type":33},{"date":62,"type":33},"2026-03-16",{"date":64,"type":21},"2029-03-31",{"name":66,"class":40},"Zuyderland Medisch Centrum",{"id":68,"slug":69,"hasResults":12,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":78,"conditions":79,"keywords":85,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":41},"100649367","inflammation-and-diabetes-evaluating-antioxidant-levels-100649367","NCT07734428","Inflammation and Diabetes: Evaluating Antioxidant Levels","The Relationship Between Dietary Antioxidant Capacity, Inflammatory Response, and Nutritional Parameters in Type 2 Diabetes Management","IDEAL","Inclusion Criteria:\n\n* Adults aged 18 and older diagnosed with Type 2 Diabetes.\n* Individuals whose biochemical analyses have been performed by a physician within the last 1 month.\n* Individuals willing to participate voluntarily.\n\nExclusion Criteria:\n\n* Missing required laboratory data in the last 1 month.\n* Presence of acute infection or inflammatory disease.\n* Advanced kidney or liver failure.\n* Active malignancy or receiving chemotherapy\u002Fradiotherapy.\n* Pregnant and lactating women.\n* Use of antioxidant\u002Fvitamin-mineral supplements.\n* Receiving special diet therapies (e.g., time-restricted, ketogenic, or elimination diet).\n* Advanced cognitive impairment or communication difficulties.","65 Years",{"count":77,"type":21},180,"The goal of this observational, cross-sectional study is to evaluate the relationships between dietary total antioxidant capacity, systemic inflammatory response markers, and nutritional parameters in adult patients with Type 2 Diabetes (T2DM). Participants will be classified into controlled (HbA1c \\\u003C %7) and uncontrolled (HbA1c ≥ %7) diabetes groups based on their glycemic control. The main questions it aims to answer are: Does dietary antioxidant capacity affect systemic inflammation levels and metabolic parameters? Is there a relationship between nutritional risk status and inflammatory response in T2DM patients?",[27,80,81,82,83,84],"Diabete Type 2","Inflamation","Systemic Inflammation","Dietary Inflammatory Index (DII)","Systemic Inflammation Markers",[86,87,88,89,90,91,92,93,94,95],"diabetes","type 2 diabetes mellitus","dietary infammation","systemic inflammation","antioxidant","antioxidant status","Health and Quality of Life","Dietary Antioxidant Capacity","TyG Index","Metabolic Control","NOT_YET_RECRUITING","2026-07-24",{"date":99,"type":33},"2026-07-29",{"date":101,"type":21},"2026-07-15",{"date":103,"type":21},"2026-12-30",{"name":105,"class":40},"Istanbul Bilgi University",{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":4},"100647160","phase-4-effect-of-tirzepatide-on-diabetic-peripheral-sensorimotor-neuropathy-100647160","NCT07706088","Effect of Tirzepatide on Diabetic Peripheral Sensorimotor Neuropathy","Effect of Tirzepatide on Diabetic Peripheral Sensorimotor Neuropathy: A Randomized, Open Label, Controlled Study","T-DPN","Inclusion Criteria:\n\nEligible participants (≥ 18 years) with diabetes duration of \\\u003C 10 years, baseline HbA1c between 7% and 10% Signs and symptoms of DSPN based on a Michigan Neuropathy Screening Instrument (MNSI) history composite score of \\>= 7 OR MNSI examination SCORE \\>= 2.5 will be enrolled.\n\nBMI \\>= 27 KG\u002Fmetre 2.\n\nExclusion Criteria:\n\n1. participants with untreated hypothyroidism\n2. history of leprosy\n3. peripheral vascular disease defined by ankle-brachial index (ABI) \\< 0.9\n4. serum B12 levels \\\u003C 200 pg.\u002FmL\u002F if low will be supplemented\n5. history of alcohol excess (\\>=2 and \\>= 1 standard drink per day for male and female respectively)\n6. any condition affecting corneal nerves (severe dry eyes, severe corneal dystrophies, ocular trauma or surgery in the preceding 6 months or Sjogren\\'s or sicca syndrome\n7. use of oral contraceptives.",{"count":115,"type":21},40,[117],"PHASE4","Tirzepatide is a dual agonist of GLP-1 Receptor and the GIP receptor, producing substantial improvement in glycaemic control, weight reduction and insulin sensitivity. Beyond its metabolic effects, incretin signalling has demonstrated neuroprotective and neurotropic properties, including activation of intracellular pathways that enhance neuronal survival and regeneration.\n\nUsing tirzapatide for diabetic sensorimotor peripheral neuropathy and assessing with CCM \u002F NCS and BDNF will represent three complementary aspects of nerve regeneration: metabolic control, structural nerve repair and neurotrophic signalling.",[120,27],"Neuropathy, Small Fiber",[86,122,123],"neuropathy","tirzepatide","2026-07-10",{"date":101,"type":33},{"date":127,"type":21},"2026-07",{"date":129,"type":21},"2028-07-01",{"name":131,"class":40},"Post Graduate Institute of Medical Education and Research, Chandigarh",{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":139,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":140,"targetDuration":142,"studyType":52,"phases":4,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":4},"100644912","faisalabad-initiative-of-research-and-management-of-ncds-100644912","NCT07676214","Faisalabad Initiative of Research and Management of NCDs","FIRM-NCD","Inclusion Criteria:\n\nAge: 18 years and above Gender: Both male and female Permanent residents of the selected study areas Willing to participate and provide informed consent\n\nExclusion Criteria:\n\nPregnant and lactating women Oral and injectable contraceptive users Individuals with severe physical or cognitive impairments that prevent them from providing informed consent or participating in the screening procedures Individuals with implanted electronic medical devices (e.g., pacemakers or implantable cardioverter-defibrillators) will not undergo bioelectrical impedance analysis (BIA) for body composition assessment.",true,{"count":141,"type":21},3000,"3 Months","The burden of noncommunicable diseases (NCDs) continues to rise globally, and they have become the leading cause of morbidity and mortality, accounting for over 70% of deaths worldwide¹. Rapid lifestyle transitions and increasing urbanization have disproportionately affected low- and middle-income countries, which now bear a substantial share of the global NCD burden.\n\nPakistan, with a population of 241.5 million, is experiencing a double burden of both communicable diseases and NCDs¹³. The widespread adoption of sedentary lifestyles and unhealthy dietary patterns has contributed to a marked increase in NCDs across the country².\n\nAccording to the WHO Hypertension profile 2025, it is the most prevalent NCD in Pakistan, affecting approximately 42% (41% males and 44% females) of the population¹¹, followed by diabetes, with a reported prevalence of 30.8%¹². Additionally, a recent cross-sectional study among adults attending a tertiary care hospital in Islamabad reported dyslipidemia in 71.6% of men and 78.4% of women, indicating a substantial underlying community burden³. Pakistan also ranks tenth among 188 countries in terms of overweight and obesity prevalence, with nearly half of its population classified as overweight or obese⁴. According to World Health Organization data, 58.1% of Pakistanis are overweight, and 43.9% fall within the obese category⁴.\n\nDespite their profound public health and economic implications, efforts to address NCDs remain fragmented and insufficient.17 There remains a significant research gap in community-based NCD screening initiatives, particularly within the suburban and peri-urban communities of Faisalabad creating an unmet need to initiate a preventive strategy at community level to raise awareness about these diseases. This direction will minimize the increasing incidence and prevalence of NCDs and will ensure the quality health outcomes for better future.\n\nTimely identification of these diseases through screening is a critical step in reducing their impact on individuals and societies. Early detection enables cost-effective management, improved patient outcomes and a higher quality of life.14 One of the most important ways of reducing deaths from noncommunicable diseases (NCDs) is to control the risk factors that lead to their development.6 In this context, the present study aims to evaluate a community-based project focusing on disease awareness, screening, and structured referral to trained treating physicians for early diagnosis and management of major NCDs. The findings are expected to inform scalable, evidence-based interventions to reduce NCD burden and improve population health outcomes in Pakistan.",[27,57,56,145],"Obesity (Disorder)",[147,148,57,149,150],"community screening","Diabetes","Obesity","Hypercholestrolemia","2026-06-24",{"date":153,"type":33},"2026-06-30",{"date":155,"type":21},"2026-08-01",{"date":157,"type":21},"2027-12-31",{"name":159,"class":160},"Getz Pharma","INDUSTRY",{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":169,"enrollmentInfo":170,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":41},"100621889","duodenal-pulsendo-as-an-early-treatment-for-type-2-dm-100621889","NCT07376486","Duodenal pulsENDO as an Early Treatment for Type 2 DM","Duodenal Recellularization Via Electroporation Therapy as an Early Treatment for Type 2 Diabetes Mellitus (DREAM-1 Study)","DREAM-1","Inclusion Criteria:\n\n* Duration of T2DM \\\u003C\u002F= 2 years\n* HbA1c \\\u003C\u002F= 7.5%\n* On 0-1 oral diabetes medications\n\nExclusion Criteria:\n\n* Previous treatment with pulsENDO or similar procedure\n* Previous GI surgery that could preclude the ability to perform pulsENDO, or acute gastric and duodenal pathology that increased the risk of pulsENDO\n* Type I DM, DM secondary to specific disease or having any history of ketoacidosis\n* Fasting C-peptide level \\\u003C0.5ug\u002FL\n* Any inflammatory disease of the gastrointestinal tract such as Crohn's disease\n* Abnormal pathologies or conditions of the gastrointestinal tract, including duodenal polyps, ulcers or upper gastrointestinal bleeding conditions within 3 months of study\n* Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000\u002Fmicroliter or known coagulopathy\n* Currently taking prescription antithrombotic therapy (e.g., anticoagulant or antiplatelet agent) within 10 days prior to study and\u002For there is a need or expected need to use during the study period\n* Currently taking medications known to cause significant weight gain or weight loss (e.g. chemotherapeutics)\n* Patients who have used non-steroidal analgesics and anti-inflammatory drugs (NSAID) and corticosteroids in the past 1 month\n* Underlying uncontrolled endocrine problem that leads to obesity, including and not limited to hypothyroidism, Cushing syndrome and eating disorder.\n* Patients with contra-indications to endoscopy\n* Malignancy\n* Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma)\n* Pregnant or breast feeding\n* ASA grade IV \\& V\n* Mental or psychiatric disorder; Drug or alcohol addiction\n* Other cases deemed by the examining physician as unsuitable for safe treatment\n* Refusal to participate","60 Years",{"count":115,"type":21},[24],"This study is designed to evaluate the efficacy and safety of endoscopic duodenal re-cellularization therapy using pulsed electric field in individuals with in patients with a recent diagnosis of type 2 diabetes mellitus (T2DM).",[27,174],"T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)","2026-06-20",{"date":151,"type":33},{"date":178,"type":21},"2026-09-01",{"date":180,"type":21},"2032-08-30",{"name":182,"class":40},"Chinese University of Hong Kong",{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":192,"conditions":193,"keywords":199,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":41},"100639891","impact-of-glp-1-receptor-agonists-on-dry-eye-disease-in-patients-with-type-2-diabetes-mellitus-and-obesity-100639891","NCT07605572","Impact of GLP-1 Receptor Agonists on Dry Eye Disease in Patients With Type 2 Diabetes Mellitus and Obesity","GALENOS","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Patients who have not previously received GLP-1 receptor agonists (GLP-1 RAs).\n3. Patients able to provide informed consent for participation in the study.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding patients.\n2. History of multiple severe hypoglycemic episodes within the past two years.\n3. Active intraocular inflammation in either eye, such as infectious conjunctivitis, keratitis, scleritis, endophthalmitis, or autoimmune uveitis.\n4. Patients who have undergone cataract surgery or vitrectomy within the past 6 months.\n5. History of ketoacidosis or metabolic acidosis.\n6. History of corneal transplantation.",{"count":191,"type":21},100,"Diabetes mellitus (DM), prediabetes, and obesity are emerging as major global public health problems, with their epidemic spread continuously increasing over the past decades. The occurrence of diabetic retinopathy, cataract, glaucoma, and ocular surface disease in patients with diabetes mellitus has been extensively investigated in several studies. However, mild ocular surface disorders, such as dry eye disease, have often been overlooked, with a previous study showing that 51.3% of diabetes-related dry eye disease cases remained underdiagnosed. Among systemic diseases, diabetes mellitus and obesity have been associated with an increased risk of developing dry eye disease. Chronic hyperglycemia in diabetes leads to microvascular damage, including corneal neuropathy and reduced tear production, conditions that can disrupt ocular surface health, while systemic inflammation and meibomian gland dysfunction also contribute to this process. However, the effect of newer classes of antidiabetic medications, including glucagon-like peptide-1 receptor agonists (GLP-1 RAs), on ocular surface health remains insufficiently understood. The aim of this prospective cohort study is to evaluate the effects of GLP-1 receptor agonists on dry eye disease in patients with type 2 diabetes mellitus and obesity through the assessment of ocular surface parameters, such as tear film break-up time, Schirmer test results, as well as potential changes in corneal topography.",[194,27,195,196,197,198],"Dry Eye Disease (DED)","GLP-1","Ocular Surface","Diabetes Type 2","Cornea",[200,197,201,198],"Dry eye disease","GLP-1 Receptor Agonists","2026-05-29",{"date":204,"type":33},"2026-06-02",{"date":206,"type":33},"2026-03-01",{"date":208,"type":21},"2027-02-28",{"name":210,"class":40},"Attikon Hospital",{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":139,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":218,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":219,"conditions":220,"keywords":222,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":41},"100640638","oral-health-and-systemic-diseases-survey-of-general-practitioners-100640638","NCT07604493","Oral Health and Systemic Diseases: Survey of General Practitioners","Oral Health and Systemic Diseases: An Investigative Survey of General Practitioners","Inclusion Criteria:\n\n* Licensed General Practitioners currently practicing in Italy\n* Ability to understand and complete the questionnaire in Italian\n* Voluntary agreement to participate after reading study information and providing informed consent\n\nExclusion Criteria:\n\n* Physicians not currently practicing as General Practitioners\n* Incomplete questionnaire responses\n* Duplicate submissions\n* Participants who decline informed consent",{"count":191,"type":21},"This cross-sectional observational study aims to assess the level of knowledge, clinical practices, and professional attitudes of General Practitioners (GPs) regarding oral health and its relationship with major systemic diseases, with particular emphasis on periodontal disease. Data will be collected through an anonymous, self-administered digital questionnaire distributed nationwide to General Practitioners practicing in Italy. The questionnaire will investigate participants' knowledge of oral diseases, awareness of oral-systemic associations, early identification of oral manifestations, educational background, and interdisciplinary collaboration with dental professionals.",[221,27],"Periodontal Disease",[223,86,224],"smoking","periodontitis","2026-05-23",{"date":227,"type":33},"2026-05-28",{"date":229,"type":33},"2026-01-01",{"date":231,"type":21},"2027-01-01",{"name":233,"class":40},"University of Roma La Sapienza",{"id":235,"slug":236,"hasResults":12,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":241,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":243,"conditions":244,"keywords":249,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":257,"locationsCount":41},"100640196","clinical-information-system-impact-on-hospitalized-patients-with-chronic-disease-100640196","NCT07609381","Clinical Information System Impact on Hospitalized Patients With Chronic Disease","Evaluating the Impact of Alberta Health Services' New Provincial Clinical Information System on Patient Outcomes and Experiences With Chronic Diseases - Study Protocol for a Multi-center Interrupted Time Series Analysis","Inclusion Criteria:\n\n* Adults aged 18 years or older at the time of hospital admission.\n* Residents of Alberta eligible to receive acute-care services in AHS facilities.\n* Hospitalized for any cause during the study period (5 years pre-implementation and 2 years post-implementation of the CIS).\n* Meet the validated case definition for one or more of the five key NCDs (diabetes mellitus, chronic kidney disease, coronary artery disease, heart failure, or chronic lung disease) based on ICD codes, laboratory measures, or pharmacy records during standardized lookback periods (up to 5 years for diagnoses; up to 1 year for labs\u002Fpharmacy).\n* Have a qualifying date for the NCD(s) that occurs prior to or during the index hospital admission.\n* Eligible for inclusion in the primary and patient experience outcomes if they survive to hospital discharge.\n* May enter multiple sub-cohorts if more than one NCD is present.\n\nExclusion Criteria:\n\n* Individuals younger than 18 years at the time of hospital admission.\n* Non-residents of Alberta or individuals not eligible for care within AHS facilities.\n* Hospitalizations that end in death (excluded from analyses of the primary outcome and patient experience measures).\n* Patients without evidence of any of the five key NCDs during the lookback period or at the index hospital admission.\n* Admissions outside the study period or admissions for which necessary administrative, laboratory, or pharmacy data are unavailable.",{"count":242,"type":21},124240,"This is a retrospective, observational study using routinely collected information collected by Alberta Health Services. The study will identify patients with chronic disease, defined by one or more of the following conditions; diabetes mellitus, heart failure, coronary artery disease, chronic kidney disease, or chronic lung disease. Adult residents of Alberta with a chronic disease of interest present upon hospital admission and who survive to hospital discharge will be included in the study cohort. The primary outcome will be the composite of hospital readmission or death within 30 days of discharge. Secondary outcomes will include components of the composite, length of stay, patient experiences related to their hospital to home transition of care, and processes of care. Multi-level interrupted time series analysis will be used to compare outcomes before versus after implementation of the Connect Care CIS.",[27,245,246,247,248],"Kidney Disease","Heart Failure","Coronary Artery Disease","Chronic Lung Diseases",[250],"Clinical Information System","2026-05-19",{"date":253,"type":33},"2026-05-27",{"date":255,"type":21},"2026-06-01",{"date":157,"type":21},{"name":258,"class":40},"University of Calgary",{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":266,"targetDuration":142,"studyType":52,"phases":4,"briefSummary":268,"conditions":269,"keywords":274,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":4},"100637631","cgm-experience-preferences--blood-glucose-parameters-100637631","NCT07607015","CGM Experience, Preferences & Blood Glucose Parameters","Instara™-1 Dual Perspectives on Continuous Glucose Monitoring: Understanding Patient Experience and Healthcare Professional Preferences","Inclusion Criteria:\n\n* Subjects to provide written informed consent prior to any study procedures being performed\n* Subjects with age 18 and above both male and female\n* Diagnosed with Diabetes Miletus Type I, Type II and\u002For GDM\n* Comfortable using smart phone, access to internet along with Bluetooth connectivity throughout the study duration.\n* Subjects (Patients) on oral or injectable anti-diabetic medications, (in case of insulin, patient must be on insulin from last 3 months )\n* Subjects (HCPs) healthy, Pre-diabetes or Diabetes Miletus (any type)\n\nExclusion Criteria:\n\n* History of hypersensitivity to any of the active or inactive ingredients of the CGM device used in the trial, and\u002For history of significant allergic skin reactions.\n* Presence of severe diabetes complications e.g. retinopathy, acute metabolic crisis, etc.\n* History of active\u002F acute renal and\u002For hepatic failure.\n* Patients who have been admitted to the hospital in the past 3 months for diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state.\n* History of critical illness or incapacitated patients\n* History of acute psychiatric disorder or exacerbation of chronic psychiatric disorder.\n* History or presence of a medical condition or disease that in the investigator's opinion would embarrass glycemic control and completion of the study.\n* Medical conditions that require patients to undergo frequent radiation\u002F imaging procedures for example CT, MRI and X rays\n* History of known hematological disorders such as Sickle Cell Disease \\& Trait, Thalassemia, Hemolytic Anemias (e.g., G6PD deficiency, autoimmune), Iron Deficiency Anemia\n* Patients on high doses of acetaminophen (\\>1 gram every 6 hours), ascorbic acid supplements (e.g., \\> 500-1000 mg\u002Fday), IV sorbitol, steroids and aspirin which can alter the readings on the CGM device.",{"count":267,"type":21},75,"This is an open-label, prospective, multicenter observational study designed to evaluate the perceived benefits, device experience, preference, and glucose-related parameters associated with the Instara-1 Continuous Glucose Monitoring device. The study will include patients with diabetes and healthcare professionals. Patients will use Instara- 1 and will be followed up to assess device experience, glucose parameters, and diabetes-related quality of life. Healthcare professionals will evaluate device experience and preference, including comparison with FreeStyle Libre 2.",[27,270,271,272,273],"Type2diabetes","type1diabetes","Gestational Diabetes","Pre Diabetes",[275,276,277,278,279,280,281],"CGM","Glucose monitoring","Time in range","estimated HbA1c","Time above range","Time below range","Diabetes Quality of life",{"date":283,"type":33},"2026-05-26",{"date":285,"type":21},"2026-09-10",{"date":287,"type":21},"2027-08-10",{"name":159,"class":160},{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":295,"eligibilityCriteria":296,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":22,"phases":299,"briefSummary":300,"conditions":301,"keywords":302,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":309,"completionDateStruct":311,"leadSponsor":313,"locationsCount":4},"100640434","hypertension-treatment-in-nigeria-hypertension-diabetes-integration-study--formative-aim-3-100640434","NCT07589387","Hypertension Treatment in Nigeria: Hypertension Diabetes Integration Study- Formative Aim 3","Transforming Hypertension Treatment in Nigeria Using a Type II Hybrid, Interrupted Time Series Design - Aim 3","HTN2","Inclusion Criteria:\n\n* Aim 3 Inclusion Criteria:\n\nPatients will be screened for diabetes with symptoms of hyperglycemia or BMI \\>25 kg\u002Fm2 and over the age of 18 years old. Upon first or previous diagnosis, diabetes patients will be registered.\n\n* Adults (≥18 years),\n* Patients with previous diabetes diagnosis\n* Patients with persistently elevated random glucose \\>200 mg\u002Fdl, fasting glucose \\>126 mg\u002Fdl, or hemoglobin A1c \\>6.5% on two or more occasions (when available)\n* Patients taking glucose lowering medications\n* Pregnant women are eligible for this program, or\n* Cognitively impaired adults are eligible for this program.\n\nExclusion Criteria:\n\n* \\- This program will not include any of the following special populations:\n\n  * Individuals who are not yet adults (minors): i.e. infants, children, or teenagers \\\u003C18 years old, or\n  * Prisoners or other detained individuals.",{"count":298,"type":21},2800,[24],"The purpose of the second phase of the Hypertension Treatment in Nigeria (HTN 2.0) Program is to build upon the success of the first phase of the HTN Program (2020-2023), which implemented the WHO HEARTS package across 60 primary healthcare centers (PHCs) in the Federal Capital Territory (FCT). This program demonstrated significant improvements in hypertension treatment and control. The focus of aim 3 will be evaluating diabetes management through the implementation of the HEARTS-D bundle in 10 PHCs across the FCT that previously participated in the initial HTN Program.",[27],[303,304,305],"Nigeria","Primary Health Center","HEARTS-D","2026-05-11",{"date":308,"type":33},"2026-05-15",{"date":310,"type":21},"2026-05-01",{"date":312,"type":21},"2030-01-31",{"name":314,"class":40},"Washington University School of Medicine",{"id":316,"slug":317,"hasResults":12,"nctId":318,"briefTitle":319,"officialTitle":320,"acronym":4,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":322,"enrollmentInfo":323,"targetDuration":4,"studyType":22,"phases":325,"briefSummary":327,"conditions":328,"keywords":330,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":335,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":41},"100639358","early-phase-1-the-role-intraoperative-salbutamol-inhaler-in-preventing-atelectasis-100639358","NCT07591558","The Role Intraoperative Salbutamol Inhaler in Preventing Atelectasis","The Role Intraoperative Salbutamol Inhaler Usage as Part of Intraoperative Regimen in Preventing Atelectasis Following Thoracic, Abdominal and Spinal Surgery in Diabetics Population","Inclusion Criteria:\n\n* The study will include patients aged 18-70 years\n* American Society of Anesthesiologists (ASA) physical status of I or II\n* Will undergo thoracic, abdominal or spinal surgery\n\nExclusion Criteria:\n\n* cardiac conditions other than hypertension like arrhythmia\n* previous cardiac surgeries and valvular heart diseases","70 Years",{"count":324,"type":21},80,[326],"EARLY_PHASE1","Atelectasis is considered a common complication in the perioperative period, especially following surgeries under general anesthesia. Postoperative atelectasis could occur anytime during the perioperative period from intraoperative period to 24 hours postoperative and contribute to a variety of other complications, including hypoxemia and pneumonia. In the literature, several methods were utilized to combat this phenomenon, therefore, we investigate the role of intraoperative salbutamol in reducing the incidence of atelectasis. It is well known that salbutamol could be an adjunctive bronchodilator medication used in the intraoperative anesthetic regimens.",[329,27],"Atelectases, Postoperative Pulmonary",[331,332,333,334],"atelectasis","salbutamol","pulmonary","bronchodilator",{"date":308,"type":33},{"date":337,"type":21},"2026-06",{"date":339,"type":21},"2026-12",{"name":341,"class":40},"King Abdullah University Hospital",{"id":343,"slug":344,"hasResults":12,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":75,"enrollmentInfo":349,"targetDuration":4,"studyType":22,"phases":351,"briefSummary":354,"conditions":355,"keywords":357,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":4},"100641378","phase-1-study-of-the-safety-and-efficacy-of-pancreatic-endocrine-cells-in-adult-patients-with-type-1-diabetes-100641378","NCT07581197","Study of the Safety and Efficacy of Pancreatic Endocrine Cells in Adult Patients With Type 1 Diabetes","A Phase 1\u002F2 Dose Escalation Study to Evaluate the Safety and Efficacy of SR-02 Pancreatic Endocrine Cell Clusters Implanted in the Omentum of Adults With Type 1 Diabetes (SUGR)","Key Inclusion Criteria\n\n* Adult 18 to 65 years with a clinical history of T1D\n* Diagnosis of T1D at \\\u003C40 years of age\n* Insulin dependence for ≥5 years at pre-screening\n* Recurrent severe hypoglycemia\n* Willingness to use continuous glucose monitoring\n\nKey Exclusion Criteria\n\n* Use of anti-diabetic agent other than insulin(s) or insulin analog(s) within 3 months of Screening\n* Weight loss medication(s) within 3 months of Screening\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply.",{"count":350,"type":21},9,[352,353],"PHASE1","PHASE2","This study will evaluate the safety, efficacy and durability of SR-02 administered to the omentum of patients of Type 1 diabetes with severe recurrent hypoglycemia. The study will also help establish the optimal treatment dose. Although this study is open to patients with all HLA or blood types, immunosuppression to prevent rejection will be required in this first in human study.",[27,356],"Diabete Type 1",[358],"Severe hypoglycemia","2026-05-06",{"date":361,"type":33},"2026-05-12",{"date":363,"type":21},"2026-11",{"date":365,"type":21},"2029-11",{"name":367,"class":160},"Seraxis",{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":139,"sex":17,"minAge":375,"maxAge":376,"enrollmentInfo":377,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":378,"conditions":379,"keywords":382,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":396,"locationsCount":41},"100635291","serum-cholinesterases-paraoxonase-and-cardiovascular-risk-after-intravitreal-bevacizumab-100635291","NCT07550777","Serum Cholinesterases, Paraoxonase, and Cardiovascular Risk After Intravitreal Bevacizumab","Serum Acetylcholinesterase, Butyrylcholinesterase, Paraoxonase Activity, and Cardiovascular Risk Factors in Patients Treated With Intravitreal Bevacizumab","Inclusion Criteria:\n\n* Age ≥ 55 years.\n* Ability to provide written informed consent.\n* Patient group: Diagnosis of macular edema secondary to diabetic retinopathy, retinal vein occlusion, or age-related macular degeneration, and having received repeated intravitreal bevacizumab injections (≥2 doses).\n* Control group: Healthy volunteers with no ocular pathology other than cataracts and not receiving intravitreal anti-VEGF treatment.\n\nExclusion Criteria:\n\n* Chronic inflammatory disease.\n* Chronic infectious disease.\n* History of cardiovascular disease (e.g., coronary artery disease, heart failure, arrhythmia requiring treatment).\n* History of cerebrovascular disease (e.g., stroke, transient ischemic attack).\n* Any additional ocular pathology that may affect the study outcomes (other than the index retinal condition in the patient group and cataract in the control group), such as:\n\nglaucoma\n\nuveitis\n\nretinal dystrophies\n\nsignificant media opacity preventing adequate ocular evaluation\n\n\\- Use of systemic medications or conditions known to affect cholinesterase activity markedly","50 Years","80 Years",{"count":77,"type":21},"Bevacizumab, an anti-VEGF (vascular endothelial growth factor) agent used in the treatment of diabetic retinopathy and macular edema associated with retinal vein occlusion, is commonly administered in ophthalmology clinics through intravitreal injection. The systemic use of bevacizumab has been associated with serious conditions such as thromboembolism and bleeding. Although intravitreal bevacizumab is administered in smaller amounts and has limited systemic circulation, it requires repeated injections over a long period. These long-term intravitreal anti-VEGF therapies may lead to adverse outcomes, particularly thromboembolism, due to systemic inhibition of VEGF. However, limited information is available regarding the potential effects of this treatment on the systemic and cardiovascular systems. To evaluate this risk, the study aims to assess changes in the activities of paraoxonase 1 (PON1), acetylcholinesterase (AChE), and butyrylcholinesterase (BChE), which are closely associated with lipid metabolism, coronary artery disease, and atherosclerosis. These enzymes are known biomarkers of cardiovascular health and play significant roles in protection against oxidative stress and inflammation. For this purpose, a case-control study is planned. Serum BChE and PON1 activities, as well as triglyceride (TG)\u002Fhigh-density lipoprotein (HDL) and TG\u002Fglucose ratios, will be determined in patients receiving repeated intravitreal bevacizumab injections and in control groups, and cardiovascular disease risk will be assessed. This study may help us better understand the safety profile of this treatment by revealing the effects of bevacizumab on serum enzyme activities and cardiovascular risk factors. These findings could contribute to optimizing treatment strategies in clinical practice.",[27,380,381],"Retina Vein Occlusion","Age Macular Degeneration",[383,384,385,386,387,388,389],"bevacizumab","paraoxonase","retinal vein occlusion","age-related macular degeneration","diabetic retinopathy","acetylcholinesterase","butyrylcholinesterase","2026-04-22",{"date":392,"type":33},"2026-04-24",{"date":394,"type":33},"2025-11-03",{"date":124,"type":21},{"name":397,"class":40},"Ataturk University",{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":402,"acronym":4,"eligibilityCriteria":403,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":404,"enrollmentInfo":405,"targetDuration":4,"studyType":22,"phases":406,"briefSummary":407,"conditions":408,"keywords":411,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":417,"completionDateStruct":418,"leadSponsor":420,"locationsCount":41},"100633393","developing-a-colonoscopy-preparation-protocol-for-patients-with-diabetes-100633393","NCT07526103","Developing a Colonoscopy Preparation Protocol for Patients With Diabetes","Inclusion Criteria:\n\n1. Patients Age over the age of 18\n2. Able to read and understand the English language\n3. Confirmed diagnosis of diabetes (Type 1 or Type 2)\n\nExclusion Criteria:\n\n1. Patients without diabetes\n2. Patients with prior hospital admission due to hypoglycemic events\n3. Patients who have inflammatory bowel disease\n4. Patients with ileus or bowel obstruction\n5. Patients with history of colorectal resection\n6. Patients receiving combined upper and lower endoscopies\n7. Patients with ascites\n8. Patients with previously documented severe renal impairment\n9. Unable to provide consent\n10. Pregnant or lactating female (females of child-bearing potential will undergo urine pregnancy testing)\n11. Patients who have had a recent myocardial infarction(\\\u003C6months)\n12. Allergy to product ingredients","75 Years",{"count":115,"type":21},[24],"Patients with diabetes have less effective colonoscopy preparation when compared to nondiabetic patients. This leads to the possibility of missed polyps, longer procedural time and patient dissatisfaction. Furthermore, the peri-colonoscopy period has been associated with increased risk of hypoglycemic events given the required change in diet and possible changes in antihyperglycemic medication regime, though this area is not well studied.\n\nStudies have found that same day preparation for colonoscopy allowed for comparable bowel visualization to split dosing. Pairing this with a low fiber diet permitted the day prior to colonoscopy, the extent of changes to routine and diet within a patient with diabetes day for colonoscopy preparation is minimized and could reduce risk of side effects and hypoglycemia, while also ensuring adequate bowel preparation.\n\nThis study tests the hypothesis that creating a diabetic specific protocol (permitting a low fibre diet the day prior to colonoscopy and using same day preparation) will result in fewer hypoglycemic events and more adequate quality preparation in comparison to a conventional 2L PEG split day preparation with dietary restrictions in patients with diabetes.",[409,27,410],"Hypoglycaemia","Colonoscopy (Ambulatory Patients)",[412,413,414],"glucose monitoring","diabetes protocol","bowel preparation","2026-04-21",{"date":392,"type":33},{"date":255,"type":21},{"date":419,"type":21},"2028-06-01",{"name":421,"class":40},"Queen's University",{"id":423,"slug":424,"hasResults":12,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":17,"minAge":430,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":22,"phases":433,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":41},"100622079","clinical-efficacy-of-implementing-an-ai-samd-for-funduscopy-analysis-in-patients-with-diabetes-mellitus-100622079","NCT07378956","Clinical Efficacy of Implementing an AI-SaMD for Funduscopy Analysis in Patients With Diabetes Mellitus","Clinical Efficacy of Implementing an AI-Driven Software as a Medical Device (SaMD) for Funduscopy Analysis in Patients With Diabetes Mellitus: A Randomized Controlled Trial Protocol","SAFE-DM","Inclusion Criteria:\n\n* Adults aged 19 years or older.\n* A documented diagnosis of type 2 diabetes mellitus.\n* Ability to communicate adequately and provide written informed consent for participation in the study.\n\nExclusion Criteria:\n\n* A prior diagnosis of diabetic retinopathy at the time of screening.\n* A history of ophthalmic surgery within 6 months prior to the screening date.\n* A diagnosis of type 1 diabetes mellitus.\n* Pregnancy at the time of screening.\n* Any condition that, in the opinion of the investigator, would make participation in the study infeasible or inappropriate.","19 Years",{"count":432,"type":21},340,[24],"The objective of this study is to investigate the efficacy of implementing the AI-SaMD(VUNO Med®-Fundus AI™) alongside routine clinical practice for the detection of diabetic retinopathy.",[436,27,437],"Diabetic Retinopathy (DR)","Fundus Photography","2026-04-08",{"date":440,"type":33},"2026-04-13",{"date":442,"type":33},"2026-04-07",{"date":444,"type":21},"2027-08-31",{"name":446,"class":160},"VUNO Inc.",{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":139,"sex":17,"minAge":18,"maxAge":75,"enrollmentInfo":453,"targetDuration":4,"studyType":22,"phases":455,"briefSummary":456,"conditions":457,"keywords":459,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":462,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":4},"100631538","the-effect-of-color-rotation-technique-training-on-nslin-self-management-n-diabetic-patients-100631538","NCT07501988","The Effect Of Color Rotation Technique Training On İnsülin Self-management İn Diabetic Patients.","Inclusion Criteria :\n\n* Between the ages of 18-65\n* At least a primary school graduate\n* Diagnosed with Type 1 or Type 2 Diabetes for at least six months\n* Receiving insulin treatment\n* Capable of self-administering insulin injections\n* Free from psychiatric illness or communication impairment (vision, hearing, and speech)\n* Able to use a mobile phone and send and receive SMS messages\n* Administering insulin injections 4 times a day\n* Individuals who agree to participate in the study\n\nExclusion Criteria:\n\n* Not using insulin treatment-Using an insulin pump\n* Having temporary insulin treatment\n* Having lipodystrophy-Individuals who refused to participate in the study or who discontinued their education",{"count":454,"type":21},112,[24],"Diabetes mellitus (DM) is a chronic disease characterized by impaired carbohydrate, protein, and lipid metabolism, resulting from a deficiency of insulin hormone secreted by the pancreas and\u002For the body's inability to utilize it even when sufficient insulin is secreted. As a frequently observed chronic disease, diabetes is a significant public health problem; if left uncontrolled, it can lead to serious complications and negatively impact quality of life.Individual management of treatment is crucial for successful treatment and glycemic control in diabetes. Due to the complexity of diabetes management related to insulin use, diabetics require greater self-care skills. Nurses play a crucial role in developing desired self-management behaviors in individuals with diabetes, supporting them, and meeting their needs.",[27,458],"İnsulin Self-management",[27,460,461],"İnsulin self-management","Nurse",{"date":438,"type":33},{"date":464,"type":21},"2026-04-15",{"date":466,"type":21},"2026-07-22",{"name":468,"class":40},"Tokat Gaziosmanpasa University",{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":473,"acronym":4,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":322,"enrollmentInfo":475,"targetDuration":4,"studyType":22,"phases":477,"briefSummary":479,"conditions":480,"keywords":481,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":490,"leadSponsor":492,"locationsCount":41},"100631658","phase-3-effect-of-tributyrin-supplementation-on-glycemic-control-inflammation-and-cardiovascular-risk-in-patients-with-type-2-diabetes-100631658","NCT07503548","Effect of Tributyrin Supplementation on Glycemic Control, Inflammation, and Cardiovascular Risk in Patients With Type 2 Diabetes","Inclusion Criteria:\n\n* • Diagnosed with Type 2 DM for ≥ 1 year\n\n  * ASCVD 10-year risk ≥ 7.5%\n  * Stable antidiabetic and cardiovascular medication regimen for ≥ 3 months\n  * Able to provide informed consent and comply with study procedures\n\nExclusion Criteria:\n\n* • Established cardiovascular disease (history of MI, stroke, or revascularization)\n\n  * Chronic gastrointestinal disorders affecting absorption\n  * Severe hepatic or renal impairment\n  * Use of GLP-1 receptor agonists or SGLT2 inhibitors\n  * Pregnancy or lactation\n  * Known hypersensitivity to tributyrin or butyrate",{"count":476,"type":21},60,[478],"PHASE3","This study evaluates the effectiveness and safety of tributyrin supplementation in patients with type 2 diabetes mellitus (T2DM) who are at increased risk of cardiovascular disease. Type 2 diabetes is commonly associated with poor blood sugar control, chronic inflammation, oxidative stress, and an increased risk of heart disease.\n\nTributyrin is a dietary supplement that acts as a precursor to butyrate, a compound known for its anti-inflammatory and metabolic benefits. It may help improve blood sugar levels, reduce inflammation, and lower cardiovascular risk.\n\nIn this randomized, double-blind, controlled clinical trial, participants will receive either tributyrin in addition to their standard diabetes treatment or standard therapy alone. The study will assess whether tributyrin improves glycemic control, inflammation, oxidative stress, lipid profile, and overall cardiovascular risk while maintaining safety and tolerability.",[27],[482,483,484,485],"Tributyrin","Diabetes mellitus","glycemic control","insulin resistance","2026-03-26",{"date":488,"type":33},"2026-03-31",{"date":486,"type":21},{"date":491,"type":21},"2026-08-26",{"name":493,"class":40},"Ain Shams University",{"id":495,"slug":496,"hasResults":12,"nctId":497,"briefTitle":498,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":139,"sex":17,"minAge":18,"maxAge":376,"enrollmentInfo":501,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":503,"conditions":504,"keywords":507,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":510,"lastUpdatePostDateStruct":511,"startDateStruct":513,"completionDateStruct":515,"leadSponsor":517,"locationsCount":4},"100629100","detection-of-diabetic-foot-skin-damage-using-plantar-mechanical-parameters-100629100","NCT07470255","Detection of Diabetic Foot Skin Damage Using Plantar Mechanical Parameters","An Exploratory Study on the Detection of Diabetic Foot Skin Damage Using Quantitative Mechanical Parameters of Plantar Skin","Inclusion Criteria:\n\n* For healthy one: Fasting blood glucose \\\u003C 6.1 mmol\u002FL and glycated hemoglobin \\\u003C 6.0%, with no history of diabetes; Foot condition: normal appearance of both feet, without wounds, deformities, trauma, infections, or dermatological disorders; voluntary participation in this study with signed informed consent.\n* For diabetic one: Confirmation of type 1 or type 2 diabetes mellitus as defined by the World Health Organization (WHO) diagnostic standards; Diagnosis of diabetic foot disease\\* consistent with the criteria established by the International Working Group on the Diabetic Foot (IWGDF); Voluntary participation in the present study with provision of signed informed consent.\n\nExclusion Criteria:\n\n* For healthy one: (1) History of foot surgery, trauma, or fractures resulting in skin scars or irreversible cutaneous damage; (2) Active chronic dermatological conditions affecting skin integrity, such as tinea pedis, eczema, or psoriasis; (3) Vascular diseases of the lower extremities (e.g., arteriosclerosis obliterans) causing muscular or cutaneous atrophy in the feet; (4) Systemic diseases impacting the skin or connective tissues, including systemic sclerosis, rheumatoid arthritis, or vasculitis; (5) Prolonged engagement in heavy physical labor or professional sports leading to abnormal thickening or hyperkeratosis of the plantar skin; (6) Presence of extensive, hyperkeratotic lesions (e.g., calluses, corns) or wounds at the measurement site impairing probe contact accuracy; (7) Inability to cooperate or diagnosed psychiatric disorders; (8) Investigator-determined unsuitability for the study or inability to comply with protocol requirements.\n* For diabetic one: (1) Uncontrolled severe acute foot infections; (2) Dermatological conditions that interfere with measurement procedures; (3) Irreversible foot skin damage due to non-diabetic etiologies such as trauma or surgical intervention; (4) Coexisting systemic disorders (excluding diabetes) that compromise skin elasticity, including systemic sclerosis, rheumatoid arthritis, or vasculitis; (5) History of above-knee amputation on the measured foot; (6) Inability to cooperate or presence of psychiatric disorders; (7) Investigator-determined ineligibility due to non-compliance concerns or unsuitability for study participation.",{"count":502,"type":21},200,"Diabetes represents one of the major chronic diseases, with diabetic ulcers being a significant adverse prognosis. Approximately 80% of lower limb amputations are attributed to diabetic foot ulcers, which constitute a primary cause of patient disability and mortality, while also imposing a substantial burden on healthcare systems. Although standardized Western medical protocols for diabetic foot management exist, clinical outcomes remain suboptimal. The amputation rate due to diabetic foot ulcers continues to rise annually, underscoring the urgent need for novel and effective interventions to address this condition.\n\nQuantitative assessment of cutaneous biomechanical parameters may indirectly reflect the cumulative damage inflicted by diabetes on foot tissues. Such evaluation provides critical guidance for predicting susceptibility to recurrent ulceration and determining the necessity of enhanced offloading strategies to prevent ulcer development. By applying specific mechanical loads to the skin and measuring deformation, rebound characteristics, and displacement dynamics under pressure, it becomes possible to quantitatively evaluate parameters such as elastic modulus and viscoelastic properties.\n\nThis case-control study aims to investigate the feasibility of utilizing plantar skin quantitative mechanical parameters as objective biomarkers for biomechanical impairment in diabetic foot. Furthermore, it seeks to establish a standardized operating procedure (SOP) for quantitative measurements tailored to diabetic foot scenarios. The study is designed to bridge critical evidence gaps between theoretical consensus and clinically applicable quantitative tools, demonstrating clear innovation and potential clinical value.",[505,27,506],"Diabetic Foot Disease","Mechanical Factor",[505,27,508,509],"Mechanical factor","plantar skin","2026-03-12",{"date":512,"type":33},"2026-03-13",{"date":514,"type":21},"2026-04-01",{"date":516,"type":21},"2028-04-01",{"name":518,"class":40},"Peking University Third Hospital",{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":4,"eligibilityCriteria":525,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":526,"targetDuration":142,"studyType":52,"phases":4,"briefSummary":527,"conditions":528,"keywords":532,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":41},"100627724","ai-based-diabetic-foot-recurrence-cohort-100627724","NCT07452354","AI-Based Diabetic Foot Recurrence Cohort","Development and Validation of an AI-Based Wound Alert System With a Home-Based Management Model for a Diabetic Foot Recurrence Cohort","Inclusion Criteria:\n\n* The patient must be aged 18 years or older; have a confirmed diagnosis of type 1 or type 2 diabetes mellitus according to the World Health Organization criteria; the wound etiology attributable to diabetic foot ulcers, with complete wound healing post-treatment defined as a dry wound devoid of exudate, complete epithelialization of both the wound bed and margins, absence of surrounding erythema or edema, and sufficient tensile strength to withstand pressure without dehiscence; voluntary participation in this study with provision of written informed consent.\n\nExclusion Criteria:\n\n* Inability of the patient to cooperate or presence of psychiatric disorders; At the investigator's discretion, the subject is deemed unsuitable for this study or unable to comply with the study requirements.",{"count":502,"type":21},"Diabetic foot ulcer (DFU) is a major adverse outcome of diabetes, which itself is one of the most significant chronic diseases. The recurrence of DFU involves multiple risk factors, including altered foot loading patterns, patient compliance, family care capacity, blood glucose monitoring, degree of ischemia, and systemic disease control. Early identification of recurrence signs and timely follow-up interventions are crucial for improving prognosis, reducing disability rates, and lowering healthcare costs. However, traditional follow-up systems lack individualized strategies-such as risk stratification, inflexible follow-up intervals, and insufficient compliance management-often resulting in suboptimal outcomes. High-risk patients prone to recurrence may not be followed up frequently enough for early detection, while low-risk patients may undergo unnecessary visits, increasing burdens on both patients and healthcare providers. This inefficiency contributes significantly to the persistently high rates of disability and mortality among recurrent DFU patients.\n\nEstablishing an individualized follow-up strategy for DFU, supported by advanced technology to address core bottlenecks such as delayed recurrence warnings and inadequate home-based management, represents an effective technical pathway to tackle these issues.\n\nOur center proposes to develop a dedicated DFU cohort with comprehensive active follow-up and a multimodal database encompassing well-defined indicators. We aim to explore a high-risk foot grading system for preventing DFU recurrence and design targeted follow-up protocols. By leveraging AI technology, we intend to build a wound warning system capable of identifying DFU recurrence. Furthermore, we seek to establish a telemedicine and AI-assisted, patient-centered home-based self-management framework for early warning and prevention of DFU recurrence.",[529,27,530,531],"Diabetic Foot Ulcer (DFU)","Diabetic Foot Ulcer Treatment","Artificial Intelligence (AI) in Diagnosis",[533,530,27,534,531],"Diabetic Foot Ulcer","Reccurrence","2026-02-28",{"date":537,"type":33},"2026-03-05",{"date":539,"type":21},"2026-03-15",{"date":541,"type":21},"2028-12-31",{"name":518,"class":40},{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":549,"eligibilityCriteria":550,"healthyVolunteers":139,"sex":551,"minAge":552,"maxAge":404,"enrollmentInfo":553,"targetDuration":554,"studyType":52,"phases":4,"briefSummary":555,"conditions":556,"keywords":561,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":575,"locationsCount":41},"100627135","erectile-function-after-pci-in-mi-and-non-mi-patients-100627135","NCT07444697","\"Erectile Function After PCI in MI and Non-MI Patients\"","Erectile Function After Percutaneous Coronary Intervention in Myocardial Infarction and Non-Infarction Patients: A Prospective Comparative Study.","ERECT-PCI","Inclusion Criteria\n\n* Male patients aged 30-75 years\n* Undergoing successful percutaneous coronary intervention (PCI) for one of the following:\n\n  * Acute myocardial infarction (Group 1)\n  * Stable angina (Group 2)\n* Hemodynamically stable after the PCI procedure\n* Survival of the index hospitalization\n* Ability to provide written informed consent\n* Sexually active within the 3 months prior to enrollment\n* Willingness and ability to complete follow-up visits and questionnaires at:\n\n  * Baseline (post-PCI recovery)\n  * 3 months\n  * 6 months Exclusion Criteria\n* Known malignancy (active or recently treated)\n* Neurological disorders affecting erectile function, including:\n\n  * Spinal cord injury\n  * Multiple sclerosis\n  * Parkinson's disease\n* Uncontrolled diabetes mellitus (HbA1c \\> 9%)\n* Presence of more than two chronic systemic diseases, such as:\n\n  * Severe renal disease\n  * Severe hepatic disease\n  * Severe pulmonary disease\n* Polypharmacy, defined as chronic use of more than three daily medications\n* Absence of sexual activity or lack of a sexual partner\n* Refusal or inability to provide informed consent or complete study questionnaires\n* Severe psychiatric illness interfering with study participation\n* Endocrine disorders, including:\n\n  * Untreated hypogonadism\n  * Thyroid disease\n* Major post-PCI complications preventing participation, including:\n\n  * Reinfarction\n  * Stroke\n  * Heart failure","MALE","30 Years",{"count":191,"type":21},"6 Months","The goal of this observational study is to assess changes in patients' erectile function after percutaneous coronary intervention (PCI) using a standard IIEF (International Index of Erectile Function) questionnaire at 1, 3, and 6 months post-PCI. By doing this, we try to compare patients' responses to PCI after having a heart attack and stable angina to see the real effect of myocardial infarction on erectile function status in the long term by comparing it with a very similar group.",[557,558,27,559,560],"Erectile Disfunction","Coronary Artery Disease (CAD)","Anxiety","Depression and Quality of Life",[562,563,564,565,566,567,568],"erectile disfunction","coronary artery disease","Syntax score","percutaneous coronary intervention","anxiety","Fear","angina","2026-02-24",{"date":571,"type":33},"2026-03-03",{"date":573,"type":33},"2026-01-15",{"date":363,"type":21},{"name":576,"class":40},"Kırıkkale University",{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":584,"targetDuration":4,"studyType":22,"phases":586,"briefSummary":587,"conditions":588,"keywords":590,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":599,"leadSponsor":600,"locationsCount":4},"100625493","telemedicine-based-behavioral-intervention-to-improve-outcomes-among-diabetic-patients-100625493","NCT07423351","Telemedicine-Based Behavioral Intervention to Improve Outcomes Among Diabetic Patients","The Effects of the Telemedicine-Based Behavioral Intervention on Improving the Outcomes of Diabetic Patients in Northwest Amhara Tertiary Hospitals, Ethiopia, 2025\u002F26: A Quasi-Experimental Study Intervention Protocol","Inclusion Criteria:\n\n* Adult patients ≥18 with diabetes mellitus who have follow-up for ≥6 months at the study settings\n* Have access to mobile or fixed telephones\n* Will stay for the study follow-up period\n\nExclusion Criteria:\n\n* Participants who have coexisting severe mental health illnesses\n* Severe hearing impairments\n* Pregnant will be excluded\n* Currently enrolled in another diabetes intervention study",{"count":585,"type":21},320,[24],"The goal of this quasi-experimental clinical study is to learn whether a telemedicine-based behavioral intervention can improve health outcomes among adult patients with diabetes receiving care at tertiary hospitals in Northwest Amhara, Ethiopia.\n\nThe main questions it aims to answer are:\n\n* Does a telemedicine-based behavioral intervention improve glycemic control (HbA1c) among diabetic patients?\n* Does the intervention improve medication adherence among diabetic patients?\n* Does the intervention improve diabetes self-care practices?\n* Does the intervention increase patients' knowledge about diabetes?\n* Does the intervention reduce hospital admissions among diabetic patients?\n\nWe will compare patients who receive telemedicine-based counseling with patients who receive usual care to see if the intervention improves glycemic control, medication adherence, self-care practices, diabetes knowledge, and reduces hospital admissions.\n\nParticipants will:\n\n* Receive structured telephone-based education every two weeks for three months (intervention group only)\n* Participate in 30-50-minute counseling sessions during the first call and 15-30 Minutes sessions during subsequent calls (intervention group only)\n* Receive education on diabetes basics, nutrition and meal planning, physical activity, medication management, blood glucose monitoring, complication prevention, and psychosocial support (intervention group only)\n* Engage in interactive discussions and receive individualized guidance from trained nurses (intervention group only)\n* Continue routine diabetes care at the hospital (both groups)",[27,589],"Diabetes Knowledge Score",[591,592,593,594],"Behavioral intervention","Diabetes Mellitus","Telemedicine","Quasi-experimental study","2026-02-19",{"date":597,"type":33},"2026-02-20",{"date":597,"type":21},{"date":124,"type":21},{"name":601,"class":40},"Bahir Dar University",{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":607,"acronym":608,"eligibilityCriteria":609,"healthyVolunteers":139,"sex":17,"minAge":18,"maxAge":610,"enrollmentInfo":611,"targetDuration":4,"studyType":22,"phases":612,"briefSummary":613,"conditions":614,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":619,"completionDateStruct":620,"leadSponsor":622,"locationsCount":624},"100622028","phase-1-effects-of-selected-statins-on-blood-glucose-levels-in-healthy-volunteers-100622028","NCT07378293","Effects of Selected Statins on Blood Glucose Levels in Healthy Volunteers","Effects of Selected Statins on Blood Glucose Levels in Healthy Volunteers: A Randomized Phase I Clinical Trial","[Statins]","Inclusion Criteria:\n\n* healthy volunteers\n* Non diabetic\n* blood glucose level (less than140 mg\u002Fdl)\n\nExclusion Criteria:\n\n* Participants with a history of diabetes mellitus\n* With chronic diseases e.g heart disease, kidney disease\n* participants taking other medications","55 Years",{"count":191,"type":21},[352],"This Phase I randomized clinical trial aims to investigate the short-term effects of three commonly prescribed statins (atorvastatin, rosuvastatin, and simvastatin) at different dose levels on blood glucose homeostasis in healthy volunteers. The study will assess changes in fasting blood glucose, insulin, and C-peptide levels following two days of statin administration under controlled conditions. The research seeks to provide comparative data on the potential diabetogenic effects of these medications.",[27,615],"Lipid Profile","2026-01-26",{"date":618,"type":33},"2026-01-30",{"date":206,"type":21},{"date":621,"type":21},"2027-02-20",{"name":623,"class":40},"Shaheed Benazir Bhutto University Sheringal Dir Upper",2,{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":629,"acronym":4,"eligibilityCriteria":630,"healthyVolunteers":139,"sex":17,"minAge":18,"maxAge":376,"enrollmentInfo":631,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":632,"conditions":633,"keywords":4,"overallStatus":96,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":636,"completionDateStruct":638,"leadSponsor":640,"locationsCount":4},"100619363","assessment-of-antithyroglobulin-antibody-levels-among-diabetic-patients-100619363","NCT07343648","Assessment of Antithyroglobulin Antibody Levels Among Diabetic Patients","Inclusion Criteria:\n\n* Adult aged 18-80 years, both genders.\n* established diagnosis with diabetes mellitus\n\nExclusion Criteria:\n\n* History of thyroid disease\n* Prior thyroid surgery\n* Current thyroid replacement or anti-thyroid medication\n* Use (within last 3 months) of drugs known to affect thyroid function or antibodies\n* Pregnancy or breast feeding",{"count":454,"type":21},"Assessment of antithyroglobulin antibody (anti Tg) level among diabetic patients explores the intersection between autoimmune thyroid disease and diabetes mellitus. Autoimmune thyroiditis and diabetes frequently coexist, and anti Tg is one of the main markers used to document thyroid autoimmunity.(1,2) Thyroglobulin is a large iodinated glycoprotein produced by thyroid and serves as the precursor for thyroid hormone synthesis. Damage to thyroid tissue in autoimmune thyroiditis leads to production of autoantibodies against thyroglobulin (Tg)(1,3). Anti Tg is therefore considered serologic hallmarks of autoimmune thyroiditis. The presence of this antibody may also be used to monitor thyroid damage progression and predict the development of overt hypothyroidism in at risk populations(1,3).\n\nType 1 diabetes mellitus (T1DM) is an organ specific autoimmune. Because of shared genetic susceptibility and overlapping immune mechanisms, patients with T1DM have a markedly increased prevalence of autoimmune thyroiditis compared with the general population. International guidelines support routine screening for thyroid autoantibodies and thyroid function in T1DM to enable early detection of subclinical thyroid dysfunction(2,4).\n\n. A study reported that, among 60 T1DM patients without known thyroid disease, 16.7% were positive for anti Tg, and subclinical or overt hypothyroidism was present in a substantial fraction of this antibody positive individuals. Other series similarly show that thyroid autoantibodies are common in T1DM and that their presence predicts later thyroid dysfunction. (5,6).\n\nIncreasing evidence indicates that type 2 diabetes mellitus (T2DM) is also associated with a higher prevalence of thyroid autoantibodies than nondiabetic controls in many studies(1,7). In a study including 72 T2DM patients, 20.8% had either anti TPO or anti Tg positivity, and 8.3% had isolated anti Tg antibodies, with rates comparable to or higher than those reported in regional control populations. A study of female T2DM patients found anti Tg in 61.3% of cases compared with no positives in the control group, and more than half of hypothyroid diabetic patients had anti Tg positivity, suggesting a significant autoimmune contribution to thyroid dysfunction in some T2DM cohorts. (2,8).\n\nAutoimmune clustering means that diabetic patients, are predisposed to additional organ specific autoimmune diseases, including autoimmune thyroiditis. Screening for anti Tg provides a more complete picture of thyroid autoimmunity. (2,8)",[27],"2026-01-07",{"date":573,"type":33},{"date":637,"type":21},"2026-02",{"date":639,"type":21},"2027-03",{"name":641,"class":40},"Assiut University",{"id":643,"slug":644,"hasResults":12,"nctId":645,"briefTitle":646,"officialTitle":647,"acronym":4,"eligibilityCriteria":648,"healthyVolunteers":12,"sex":17,"minAge":649,"maxAge":650,"enrollmentInfo":651,"targetDuration":4,"studyType":22,"phases":653,"briefSummary":654,"conditions":655,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":657,"startDateStruct":659,"completionDateStruct":661,"leadSponsor":662,"locationsCount":624},"100618048","phase-4-efficacy-of-placental-membrane-dressings-in-accelerating-diabetic-foot-healing-100618048","NCT07326553","Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing","A Randomized, Open-Label Trial Evaluating the Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing Compared to Matched Historical Controls Receiving Standard of Care","Inclusion Criteria.\n\n1. Patient has signed the informed consent form.\n2. Male or female patient at least 18 years of age or older, as of the date of the screening visit.\n3. Confirmed diagnosis of Type 1 or Type 2 DM.\n4. Has a DFU that is located below the malleoli ranging in size from 1.0 cm2 to 20.0 cm2, post debridement, when measured by the investigator staff at the screening visit using the eKare device.\n5. The DFU has been present for ≥4 weeks and ≤12 months.\n6. The DFU is non-healing as defined as \\\u003C30% reduction in size in response to standard of care from Screening (Visit 1) to Study Day 1 (Visit 2).\n7. If more than one ulcer is present the selected target ulcer must be at least 2 cm from the nearest edge of any adjacent ulcers.\n8. The depth of the target foot ulcer is graded as Wagner Grade I or II, i.e., with no evidence of exposed muscle, tendon, bone, or joint capsule.\n9. Arterial supply adequacy to the foot with the target ulcer confirmed by any one of the following and documented in medical record\u002FEMR:\n\n   1. Great toe pressure ≥ 40 mm\u002FHg\n   2. Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.70 ≤ 1.20\n   3. TcPO2 ≥ 30 mmHg from the foot\n   4. Toe Brachial Index or TBI ≥ 0.65\n10. Willing to follow all instructions given by the Investigator, return for all visits, and adhere to off-loading protocols while on the study.\n\nExclusion Criteria\n\n1. Hemoglobin A1c (HbA1c) level is \\> 10%.\n2. Chronic oral steroid use of \\> 7.5 mg daily within the previous 30 days preceding screening.\n3. Chronic oral or parenteral corticosteroids, or any cytotoxic agents within the previous 30 days preceding screening.\n4. Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS).\n5. Has malignancy or history of cancer in 5 years preceding the screening visit other than non- melanoma skin cancer.\n6. Pregnant or lactating women.\n7. Women of child-bearing potential who are unwilling to avoid pregnancy or use an effective form of birth control.\n8. Currently on dialysis or planning to start dialysis.\n9. Is currently enrolled or participated in another device, drug, or biological trial within 30 days of screening.\n10. Has used wound treatments with enzymes, growth factors, living skin, dermal substitutes including other amniotic or umbilical cord tissue therapies, or other advanced biological therapies within the last 30 days.\n11. Current use of topical anti-microbial or silver-containing products.\n12. Target ulcer is over an active or inactive Charcot deformity.\n13. The depth of the target ulcer is graded as Wagner Grade III or higher, i.e., with evidence of exposed muscle, tendon, bone, and\u002For joint capsule.\n14. Gangrene is present on any part of the affected foot.\n15. Current suspicion of osteomyelitis, cellulitis, or other clinical signs or symptoms of target ulcer infection.\n16. Any previous use of human placental membrane applied to the target ulcer.","45 Years","85 Years",{"count":652,"type":21},30,[117],"Evaluation of Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing",[27,656],"Foot Ulcer Chronic",{"date":658,"type":33},"2026-01-08",{"date":660,"type":33},"2025-12-01",{"date":37,"type":21},{"name":663,"class":160},"BioXTek"]