[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525657":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":36,"locations":45,"responsibleParty":69,"collaborators":71,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":12,"enrollmentInfo":84,"targetDuration":12,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":101,"overallStatus":48,"whyStopped":12,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Heinrich-Heine University, Duesseldorf","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"PTA within 48h","EXPERIMENTAL","A study participant in this group will receive a PTA in 'readiness', which means within 48 hours after diagnosis of a flow-limiting leg artery stenosis.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"PTA within 6 weeks","ACTIVE_COMPARATOR","A study participant in this group will receive a PTA according to the international guidelines, which means within 6 weeks after diagnosis of a flow-limiting leg artery stenosis.",[18],"Procedure: Percutaneous transluminal angioplasty",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"PROCEDURE","Percutaneous transluminal angioplasty","Percutaneous transluminal angioplasty of the leg",[14],[26,30,33],{"name":27,"affiliation":28,"role":29},"Malte Kelm, Prof.","Clinic for Cardiology, Pneumology and Angiology at University Hospital Düsseldorf","STUDY_CHAIR",{"name":31,"affiliation":32,"role":29},"Michael Roden, Prof.","Division of Diabetology and Endocrinology",{"name":34,"affiliation":28,"role":35},"Hans Lucas Busch, MD","PRINCIPAL_INVESTIGATOR",[37,41],{"name":34,"role":38,"phone":39,"phoneExt":12,"email":40},"CONTACT","+49 (0)211 81 08753","hanslucas.busch@med.uni-duesseldorf.de",{"name":42,"role":38,"phone":43,"phoneExt":12,"email":44},"Lisa Dannenberg, MD","+492118105315","lisa.dannenberg@med.uni-duesseldorf.de",[46],{"facility":47,"status":48,"city":49,"state":12,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"University-Hospital Düsseldorf Division of Cardiology, Pulmonary Disease and Vascular Medicine","RECRUITING","Düsseldorf","40225","Germany","DE",{"type":54,"coordinates":55},"Point",[56,57],6.77927,51.22319,{"lat":57,"lon":56},[60,63,64,67],{"name":61,"role":38,"phone":43,"phoneExt":12,"email":62},"Lisa Dannenberg","ctu@med.uni-duesseldorf.de",{"name":34,"role":35,"phone":12,"phoneExt":12,"email":12},{"name":65,"role":66,"phone":12,"phoneExt":12,"email":12},"Patricia Wischmann, MD","SUB_INVESTIGATOR",{"name":68,"role":66,"phone":12,"phoneExt":12,"email":12},"Kálmán Benedikt Bódis, MD",{"type":70,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR",[72],{"name":73,"class":6},"German Diabetes Center","100525657","early-percutaneous-transluminal-angioplasty-in-diabetic-foot-syndrome-pta-dfs-100525657",false,"NCT06124586","Early Percutaneous Transluminal Angioplasty in Diabetic Foot Syndrome (PTA-DFS)","Role of Percutaneous Transluminal Angioplasty for Wound Healing and Dynamics of the Microbial Community in Patients With Type 2 Diabetes and Diabetic Foot Syndrome","PTA-DFS","Inclusion Criteria:\n\n* volunteer adults\n* written informed consent\n* presence of known manifest T2D and fulfilment of the following criteria:\n* HbA1c \\\u003C 10%\n* presence of pAVD with fulfillment of the following criteria:\n* PAD Stage After Fontaine IV (foot ulcer)\n* Presence of foot ulcer with fulfillment of the following criteria:\n* Foot ulceration without indication for emergency surgical care from stage Wagner 1.\n* Age \\>18 years\n\nExclusion Criteria:\n\n* Acute leg ischemia (sudden onset, sensorimotor deficits, pale extremity, pain, loss of pulse, and shock).\n* Type 1 diabetes mellitus (GADA, ICA, IA-2A, ZnT8A positive).\n* Minors or subjects incapable of giving consent\n* Pregnant or breastfeeding women\n* Treatment with certain drugs (immunosuppressive therapy,\n* Immunomodulators, chemotherapy, antibiotic therapy \\\u003C 2 weeks before\n* intervention)\n* Diseases of the pancreas\n* Severe neurological or psychiatric disease\n* Known presence of malignant tumor disease within the past 5 years\n* Participation in other interventional trials and receipt of investigational medication within the last 30 days\n* Blood or plasma donation within the last 3 months","ALL","18 Years",{"count":85,"type":86},200,"ESTIMATED","INTERVENTIONAL",[89],"NA","The planned study is a Randomized Controlled Monocentric Trial, which will provide evidence on whether early angiography in percutaneous transluminal angioplasty (PTA) readiness (\"immediate\" treatment, within 48h) has advantages over the \"standard of care\", i.e., an elective procedure (\"elective PTA\") for the treatment of diabetic foot ulcer (DFU). The primary study endpoint is to investigate the impact of the \"early PTA\" within 48 hours on wound-healing assessed by wound area changes after PTA using a 3D-camera with artificial intelligence (AI)-based wound-analysis-system. The secondary endpoint is the effect of early PTA on the combined occurrence of major adverse limb (MALE) and cardiac events (MACE) over 12 months post-angioplasty using time-to-event analysis. Data will be collected at baseline, 24 hours, 1, 2, 3, 6, and 12 months after PTA. Diabetic kidney disease, distal symmetric polyneuropathy, retinopathy, cardiomyopathy, laboratory analyses, clinical scores, AI-based fundus photography, echocardiography, duplex sonography, and pulse oscillography will be assessed. Explanatory variables for wound healing are wound microbiome changes using whole-genome sequencing and oxygen saturation of the wound environment measured using near-infrared spectroscopy. Altered microbiome composition in ulcers can lead to severe local and systemic infections and complications, including major amputations. Nevertheless, the specific significance of the wound microbiome composition in chronic ischaemic ulcers in type 2 diabetes and the impact of PTA on the wound microbiome in type 2 diabetes is unclear. The exact timing for treating peripheral arterial disease (PAD) by revascularization in DFU after initial diagnosis is unknown and has yet to be fully understood.",[92,93,94,95,96,97,98,99,100],"Diabetic Foot","Diabetes Mellitus","Peripheral Arterial Disease","Diabetic Neuropathies","Diabetic Retinopathy","Anemia","Ulcer Foot","Ulcer Ischemic","Diabetic Polyneuropathy",[102,103,104,105,106],"diabetic foot syndrome","peripheral artery disease","diabetic food ulcers","microbiome","percutaneous transluminal angioplasty","2026-02-03",{"date":109,"type":110},"2026-02-04","ACTUAL",{"date":112,"type":110},"2024-02-01",{"date":114,"type":86},"2028-11-01",{"name":5,"class":6},1]