[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ole Lander Svendsen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":70},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100638911","phase-3-effect-of-semaglutide-on-healing-of-foot-ulcers-in-type-2-diabetes-patients-100638911",false,"NCT07581145","Effect of Semaglutide on Healing of Foot Ulcers in Type 2 Diabetes Patients","The SEMAFOOT2 Pilot Effect of Semaglutide on Healing of Foot Ulcers in Type 2 Diabetes Patients","SEMAFOOT2","Inclusion Criteria:\n\n* Diagnosis of type 2 diabetes mellitus for at least 6 months\n* Age 18-90 years\n* A foot ulcer below the level of the malleoli. If more than one ulcer, the largest will be selected at screening as the index ulcer.\n* Wound area after sharp debridement of ≥ 5 mm2, but ≤ 3000 mm2.\n\nExclusion Criteria:\n\n* Current use, or recent use (\\\u003C3 months), of GLP-1 agonists\n* Current use of DPP-IV inhibitors\n* Previous acute pancreatitis\n* Signs of infection of the index ulcer\n* Toe blood pressure \\\u003C 40 mmHg at the foot with the index ulcer\n* Current treatment with cytotoxic drugs or with systemically administered glucocorticoids\n* Hospitalisation for a major cardiovascular event or procedure or revascularization surgery on a leg in the last 3 months, or scheduled major cardiovascular intervention\n* Contraindication\u002Fintolerance to study medication\n* Pre-existing medical condition judged to preclude safe participation in the study\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* Recent use (\\\u003C 3 months) of an investigational drug or participation in interventional clinical foot ulcer-healing trial\n* Known pregnancy, breast feeding or planning pregnancy.\n* Women of childbearing potential (i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy) without a confirmed menstrual period or with a positive highly sensitive pregnancy test).\n* Women of childbearing potential not using highly effective birth control methods, such as combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal), progestogen-only hormonal contraception (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner, sexual abstinence).\n* Men, with female partners of childbearing potential, not vasectomised or not using condoms or sexual abstinence AND the female partner not using highly effective birth control, such as combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal), progestogen-only hormonal contraception (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion).\n* Likely inability to comply with the need for weekly visits because of planned activity\n* Mental incapacity, unwillingness, not speaking and understanding Danish or language barrier precluding adequate understanding or cooperation\n* Unable to provide written and signed informed consent.\n* Use of any drug which in the Investigator's opinion could interfere with the healing of foot ulcers.\n* Any clinically significant disease or disorder, except for conditions associated to the type 2 diabetes, which in the Investigator's opinion could interfere with the results of the trial\n* Active cancer or a history of cancer in the 3 years prior to signing the informed consent form (history of basal cell carcinoma is allowed).\n* Life expectancy of less than 12 months.\n* Wounds caused primarily by untreated vascular insufficiency, or where patients are primarily eligible for vascular intervention to promote wound healing.\n* Wounds with an etiology not related to diabetes.\n* Underlying osteomyelitis of the leg with the wound to be treated.\n* Patients presenting with the clinical characteristics of cellulitis at the wound site (suppurative inflammation involving particularly the subcutaneous tissue, often mild erythema, tenderness, malaise, chills and fever).\n* Surgery to lengthen Achilles tendon on the leg with the wound to be treated 3 months prior to signing the informed consent form.\n* Necrosis, purulence, or sinus tracts that cannot be removed by debridement on foot to be treated.","ALL","18 Years","90 Years",{"count":21,"type":22},52,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The aim of this exploratory pilot study is to investigate the effect of semaglutide compared to placebo on healing of foot ulcers in type 2 diabetes patients.\n\nIt is a randomized double blind, placebo controlled, clinical intervention study of 20 weeks intervention.",[28],"Foot Ulcer Due to Type 2 Diabetes Mellitus",[30,31,32],"semaglutide","randomized clinical trial","diabetic foot ulcer","RECRUITING","2026-05-06",{"date":36,"type":37},"2026-05-12","ACTUAL",{"date":39,"type":37},"2026-04-24",{"date":41,"type":22},"2029-12",{"name":43,"class":44},"Ole Lander Svendsen","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"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","80 Years",{"count":55,"type":22},38,[25],"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.",[59,60],"Charcot Foot","Diabetes Mellitus","2024-08-06",{"date":63,"type":37},"2024-08-07",{"date":65,"type":37},"2020-11-01",{"date":67,"type":22},"2026-10-01",{"name":43,"class":44},8,""]