[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"charcot-foot\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:charcot-foot":23},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,38],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":24,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":4},"100603643","risk-factor-analysis-for-charcot-foot-in-patients-with-diabetes-mellitus-the-interplay-of-inflammatory-cytokines-and-metabolic-factors-100603643",false,"NCT07139184","Risk Factor Analysis for Charcot Foot in Patients With Diabetes Mellitus: The Interplay of Inflammatory Cytokines and Metabolic Factors","RFA-CF-DM-ICMF","Inclusion . Inclusion criteria:\n\n* Adult Patients who are diagnosed with DM who are willing to participate in the study with informed consent form.\n\n  b. Exclusion criteria:\n* Patients with neuritis \u002F neuropathy of the lower extremity due to other causes other than DM\n* Significant trauma that may cause peripheral nerve damage.\n* Patient with routine use of corticosteroid\n* Previous history of smoking\n* Patients with chronic renal impairment due to diseases other than DM (creatinine \\> 1.4 mg\u002FdL), previous myocardial infarction or stroke, history of cancer.\n* Patients with iron deficiency anemia or uremia affecting HbA1c levels or elevated triglyceride or bilirubin levels.\n* Patients diagnosed with neurological disease, malignancy.","ALL",{"count":18,"type":19},60,"ESTIMATED","OBSERVATIONAL","Diabetes mellitus (DM) is among the most common metabolic disorders globally. According to the data from international research, the number of persons with diabetes mellitus reached 366 million in 2011 and is predicted to increase to 552 million by 2030.",[23],"Charcot Foot",[25],"Charcot Foot Diabetes Mellitus TNF alpha IL 10","NOT_YET_RECRUITING","2025-08-17",{"date":29,"type":30},"2025-08-24","ACTUAL",{"date":32,"type":19},"2025-10",{"date":34,"type":19},"2027-10",{"name":36,"class":37},"Assiut University","OTHER",{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":16,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"100404514","phase-3-the-denocharcot-trial-100404514","NCT04547348","The DENOCHARCOT Trial","Efficacy of Treatment With DENOsumab of an Acute CHARCOT Foot in Patients With Diabetes. A Multicenter, Double-blind, Randomized, Placebo-controlled Trial.","Inclusion Criteria:\n\n* Age 18-80 years\n* Type 1 or type 2 diabetes (diagnosed diabetes for more than 3 months)\n* Diagnosed with acute Charcot foot defined as a unilateral red, swollen and warm foot, with a difference of skin temperature of more than 2 °C compared with the unaffected foot and with sign of Charcot on either x-rays of the foot, MRI, bone scintigram or PET\u002FCT.\n* Peripheral neuropathy: Previously diagnosed and\u002For biothesiometri: \\> 25 V or lack of sensation of 10 grams monofilament on 1. toe at the acute Charcot foot.\n\nExclusion Criteria:\n\n* Duration of the acute Charcot foot for more than 3 months (at the screening visit).\n* Existing foot ulcer on the affected foot\n* Previous acute or chronic Charcot of the affected foot\n* Planned surgery on the acute Charcot foot\n* Infection (cellulitis or osteomyelitis) of the affected foot (clinically and\u002For radiologically proven)\n* Previous midfoot or proximal to mid foot amputation of the affected foot\n* Hypocalcemia (Serum Calcium \\\u003C2.1 mmol\u002FL or Calcium ion \\\u003C 1.12 mmol\u002FL)\n* Vitamin D deficiency (Serum 25-hydroxyvitamin D \\\u003C 50 nmol\u002FL)\n* Renal failure (serum creatinine \\>200 mmol\u002FL or eGFR \\\u003C 30 ml\u002Fmin).\n* Treatment with Denosumab within the last 12 months. • Have a known hypersensitivity to Denosumab • History of osteonecrosis of the jaw.\n* Poor oral hygiene, which is defined as within 3 months of a tooth extraction, dental implants or mandibular surgery\n* Planned mandibular surgery or dental implants within the next 12 months.\n* Prior non-traumatic vertebral fracture\n* Treatment with medication known to affect bones within the last 12 months (such as bisphosphonates, Forsteo®, calcitonin, Protelos®, selective estrogen receptor modulators, glucocorticoids and sex hormones)\n* Active or chronic liver disease \\*Chronic liver disease is defined as clinical history of decompensated chronic liver disease (ascites, encephalopathy or variceal bleeding) \\*Acute Liver disease is defined as an INR of \\> 1.5 (in the absence of the use of Warfarin) and AST and ALT \\> 2 x ULN\n* History of inflammatory arthropathies (rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, autoimmune arthropathy)\n* Pre-existing medical condition judged to preclude safe participation in the study\n* Current treatment with cytotoxic drugs or with systemically administered glucocorticoids\n* Abuse of alcohol or drugs, or presence of any condition that in the Investigators opinion may lead to poor adherence to study protocol\n* Pregnancy, breast feeding or planning pregnancy or not using adequate contraceptive methods. The following contraceptive products are considered to be safe: Intrauterine devices or hormonal contraception (oral contraceptive pills, implants, transdermal patches, vaginal rings or long-acting injections).\n* Likely inability to comply with the visits because of planned activity\n* Use of any investigational product with the last month.\n* Use of any drug or any other reason which in the Investigator's opinion could interfere with the outcome of the treatment of the acute Charcot foot.\n* Cancer, or any clinically significant disease or disorder, except for conditions associated to the diabetes, which in the Investigator's opinion could interfere with the results of the trial","18 Years","80 Years",{"count":48,"type":19},38,"INTERVENTIONAL",[51],"PHASE3","The aim of the present trial is to assess the efficacy of treatment of acute Charcot foot in diabetes patients with Prolia® on clinical relevant Outcomes in a randomized, double blind, placebo-controlled trial.",[23,54],"Diabetes Mellitus","RECRUITING","2024-08-06",{"date":58,"type":30},"2024-08-07",{"date":60,"type":30},"2020-11-01",{"date":62,"type":19},"2026-10-01",{"name":64,"class":37},"Ole Lander Svendsen",8]