[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556727":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":24,"locations":34,"responsibleParty":174,"collaborators":178,"id":200,"slug":12,"hasResults":201,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":201,"sex":207,"minAge":208,"maxAge":12,"enrollmentInfo":209,"targetDuration":12,"studyType":212,"phases":213,"briefSummary":215,"conditions":216,"keywords":220,"overallStatus":123,"whyStopped":12,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":233},{"fullName":5,"class":6},"School of Health Sciences Geneva","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"usual care","NO_INTERVENTION","Standard of Care treatment will be performed according to a provided standard of care manual according to most recent guidelines followed at each corresponding site (EWMA , S3-Leitlinie,…) and will proceed as follows:\n\n* Removal of old dressing\n* Application of analgesic if necessary\n* Debridement if necessary\n* Wound cleansing\n* Application of new dressing (according to the wound healing phases, medical prescription)\n* Application of compression therapy according to study standardized procedure (details in section 6.1).\n\nIn the case the participant is at home, this procedure will be performed by a caregiver.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"COMS Therapy","EXPERIMENTAL","COMS treatment will be performed 2-3 times per week for at least 8 weeks, unless the wound heals sooner, with a minimum of 16 applications. Missed sessions can be made up in the 4-week follow-up period. Treatment will occur during standard care procedures, including dressing changes and debridement, and will follow these steps:\n\nRemove old dressing Apply analgesic if necessary Perform debridement if necessary Cleanse the wound Apply COMS One device Apply new dressing Apply compression therapy as per study procedures (section 6.1)\n\nIf the patient is at home, a caregiver will perform this procedure. Study staff, including the PI, nurses, and caregivers, will receive training and a step-by-step document on using the COMS One device.",[18],"Combination Product: Concurrent optical and magnetic stimulation (COMS) treatment",[20],{"type":21,"name":22,"description":16,"armGroupLabels":23,"otherNames":12},"COMBINATION_PRODUCT","Concurrent optical and magnetic stimulation (COMS) treatment",[14],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":12,"email":29},"Sebastian Probst, Prof. Dr.","CONTACT","122-558-6563","sebastian.probst@hesge.ch",{"name":31,"role":27,"phone":32,"phoneExt":12,"email":33},"Camille Saini, Dr.","122-558-5274","camille.saini@hesge.ch",[35,52,65,80,95,106,121,135,148,161],{"facility":36,"status":37,"city":38,"state":12,"zip":12,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Medizinische Universität Graz","NOT_YET_RECRUITING","Graz","Austria","AT",{"type":42,"coordinates":43},"Point",[44,45],15.44197,47.06733,{"lat":45,"lon":44},[48],{"name":49,"role":27,"phone":50,"phoneExt":12,"email":51},"Lars-Peter Kamolz, Prof.","+43 316 385-14685","lars.kamolz@medunigraz.at",{"facility":53,"status":37,"city":54,"state":12,"zip":12,"country":39,"countryCode":40,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"Medizinische Universität Wien","Vienna",{"type":42,"coordinates":56},[57,58],16.37208,48.20849,{"lat":58,"lon":57},[61],{"name":62,"role":27,"phone":63,"phoneExt":12,"email":64},"Benedikt Weber, Prof.","+43 1 40400-77500","benedikt.weber@meduniwien.ac.at",{"facility":66,"status":37,"city":67,"state":12,"zip":12,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Augustines's Clinic","Malestroit","France","FR",{"type":42,"coordinates":71},[72,73],-2.38422,47.80967,{"lat":73,"lon":72},[76],{"name":77,"role":27,"phone":78,"phoneExt":12,"email":79},"Jean-Paul Lembelembe, Dr.","+33 02 97 73 18 24","jplembelembe@ghsa.fr",{"facility":81,"status":37,"city":82,"state":12,"zip":12,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Universitätsklinikum Essen","Essen","Germany","DE",{"type":42,"coordinates":86},[87,88],7.01228,51.45657,{"lat":88,"lon":87},[91],{"name":92,"role":27,"phone":93,"phoneExt":12,"email":94},"Joachim Dissemond, Prof.","+49 0201 723 36 41","Joachim.Dissemond@uk-essen.de",{"facility":96,"status":37,"city":97,"state":12,"zip":12,"country":83,"countryCode":84,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"University Clinic Hamburg-Eppendorf","Hamburg",{"type":42,"coordinates":99},[100,101],9.99302,53.55073,{"lat":101,"lon":100},[104],{"name":105,"role":27,"phone":93,"phoneExt":12,"email":94},"Ewa Stürmer, Prof.",{"facility":107,"status":37,"city":108,"state":12,"zip":12,"country":109,"countryCode":110,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Jura Hospital","Delémont","Switzerland","CH",{"type":42,"coordinates":112},[113,114],7.34453,47.36493,{"lat":114,"lon":113},[117],{"name":118,"role":27,"phone":119,"phoneExt":12,"email":120},"Claudio Ruzza, Dr.","+41 32 421 27 93","Claudio.Ruzza@h-ju.ch",{"facility":122,"status":123,"city":124,"state":12,"zip":12,"country":109,"countryCode":110,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Venenklinik Bellevue","RECRUITING","Kreuzlingen",{"type":42,"coordinates":126},[127,128],9.17504,47.65051,{"lat":128,"lon":127},[131],{"name":132,"role":27,"phone":133,"phoneExt":12,"email":134},"Jürg Traber, Dr.","+41 71 678 22 66","j.traber@venenklinik.ch",{"facility":136,"status":37,"city":137,"state":12,"zip":12,"country":109,"countryCode":110,"cosmosGeoPoint":138,"geoPoint":142,"contacts":143},"Cité Générations","Onex",{"type":42,"coordinates":139},[140,141],6.10237,46.18396,{"lat":141,"lon":140},[144],{"name":145,"role":27,"phone":146,"phoneExt":12,"email":147},"Dave Baer, Dr.","+4122 709 00 00","dave.baer@cpo.ch",{"facility":149,"status":37,"city":150,"state":12,"zip":12,"country":109,"countryCode":110,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"Spital Thun","Thun",{"type":42,"coordinates":152},[153,154],7.62166,46.75118,{"lat":154,"lon":153},[157],{"name":158,"role":27,"phone":159,"phoneExt":12,"email":160},"Thomas Zehnder, Dr.","+41 58 636 27 44","Thomas.Zehnder@spitalstsag.ch",{"facility":162,"status":37,"city":163,"state":12,"zip":12,"country":109,"countryCode":110,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"University Hospital","Zurich",{"type":42,"coordinates":165},[166,167],8.55,47.36667,{"lat":167,"lon":166},[170],{"name":171,"role":27,"phone":172,"phoneExt":12,"email":173},"Jürg Hafner, Prof.","+41 44 255 44 87","Juerg.hafner@usz.ch",{"type":175,"investigatorFullName":176,"investigatorTitle":177,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"SPONSOR_INVESTIGATOR","Sebastian Probst","Professor of Tissue Viability and Wound Care",[179,181,183,186,187,189,190,192,194,196,198],{"name":180,"class":6},"Medical University of Vienna",{"name":182,"class":6},"University Hospital, Geneva",{"name":184,"class":185},"Medical Centre Cité Générations","UNKNOWN",{"name":107,"class":185},{"name":188,"class":185},"Clinique des Augustines",{"name":122,"class":6},{"name":191,"class":6},"University of Hamburg-Eppendorf",{"name":193,"class":6},"Medical University of Graz",{"name":195,"class":6},"Universität Duisburg-Essen",{"name":197,"class":6},"University Hospital, Zürich",{"name":199,"class":185},"Hospital Thun","100556727",false,"NCT06528873","COMS for Chronic Ulcers Treatment","NAZARÉ: Concurrent Optical and Magnetic Stimulation (COMS) for Treatment of Patients With Chronic Ulcers of Vascular Origin in a Real-world Setting Including Care at Patient's Home, a Prospective Randomized, Controlled, Assessor Blinded, Phase IV, Clinical Trial","NAZARÉ","Inclusion Criteria:\n\nAge ≥ 18 years Clinical diagnosis of venous leg ulcer (VLU) or VLU with peripheral arterial disease (PAD) Ankle-brachial index (ABI) 0.5-1.3 or ankle pressure \\> 60 mmHg Ulcer size 2-50 cm² after debridement at screening Ulcer duration \\> 30 days and \\\u003C 2 years For patients with diabetes: HbA1c ≤ 12% at screening Able and willing to provide written informed consent prior to study procedures\n\nExclusion Criteria:\n\nPregnant or breastfeeding Malignancy in the ulcer area Use of photosensitizing medication within 30 days Severe immunosuppression (including chronic corticosteroid use \\> 10 mg\u002Fday prednisolone equivalent) NYHA class III or IV heart failure End-stage renal disease requiring dialysis Ulcer area reduction \\> 30% during run-in phase Active infection requiring systemic antibiotics at baseline Use of advanced wound therapies (e.g., negative pressure wound therapy, skin substitutes, hyperbaric oxygen) within 2 weeks prior to screening Participation in another interventional clinical trial within 30 days","ALL","18 Years",{"count":210,"type":211},122,"ESTIMATED","INTERVENTIONAL",[214],"PHASE4","Chronic leg and foot ulcers are defined as wounds that fail to heal in a timely manner, typically persisting for over 4 to 8 weeks without substantial healing despite standard care. These ulcers often result from macro- and microvascular disorders, the most common being chronic venous insufficiency (CVI), alone or with peripheral artery disease (PAD) or microangiopathy. Despite different causes, chronic vascular-origin wounds share similar biological traits and require the same physiological processes for healing.\n\nVascular issues hinder blood perfusion, reducing oxygen, nutrients, and growth factors, leading to decreased energy metabolism and impaired cell functions necessary for proliferation, extracellular matrix production, angiogenesis, and tissue regeneration. Reduced blood supply also limits leukocyte function, compromising the immune response and leading to persistent inflammation and infection. Consequently, these wounds cannot effectively heal, showing prolonged inflammation, persistent infections, and cellular senescence.\n\nBest practice wound care includes compression therapy and physical activity for venous ulcers, and angioplasty, surgery, or bypass for arterial ulcers. These treatments aim to improve blood flow, reduce venous stasis, and enhance venous return. Compression therapy and physical activity lower hydrostatic pressure in the lower limb, while angioplasty and surgery remove arterial blockages or create new blood flow routes.\n\nRecent studies highlight the role of mechano-sensitive (MS) ion channels in skin cell processes and their dysfunction in dermatological disorders. Magnetic stimulation can activate MS TRCP1 channels, enhancing mitochondrial respiration and mitochondriogenesis via the Ca2+\u002FCalModulin(CaM)\u002FNFAT\u002FPGC-1α pathway. Ca2+-activated calmodulin also catalyzes nitric oxide (NO), promoting vasodilation and tissue perfusion.\n\nBimodal red and near-infrared photobiomodulation can further increase mitochondrial respiration and ATP production by activating Cytochrome C oxidase and mitigating NO-induced downregulation. This synergistic mechanism of concurrent optical and magnetic stimulation (COMS) may amplify Ca2+ and NO-mediated processes like cell proliferation, migration, vasodilation, and angiogenesis while resolving inflammation. Thus, COMS may offer a promising therapy for chronic, inflammation-prone wounds.\n\nThe effectiveness of COMS has yet to be validated in large-scale studies. This proposal aims to assess the impact of COMS therapy combined with standard care versus standard care alone on healing, wound closure, recurrence, pain, quality of life, economic outcomes, and device usability in patients with venous leg ulcers (VLU) and VLU associated with PAD in a large-scale multicentric randomized controlled trial.",[217,218,219],"Venous Leg Ulcer","Wound Heal","Magnetic Field Exposure",[221,222,223],"Venous leg ulcer","optical stimulation","magnetic stimulation","2026-05-04",{"date":226,"type":227},"2026-05-08","ACTUAL",{"date":229,"type":227},"2025-10-01",{"date":231,"type":211},"2026-09-30",{"name":176,"class":6},10]