[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486431":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":30,"locations":41,"responsibleParty":135,"collaborators":11,"id":137,"slug":138,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":139,"sex":145,"minAge":146,"maxAge":11,"enrollmentInfo":147,"targetDuration":11,"studyType":150,"phases":151,"briefSummary":153,"conditions":154,"keywords":156,"overallStatus":44,"whyStopped":11,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: Usual Care alone","ACTIVE_COMPARATOR",null,[13],"Other: Usual Care alone",{"label":15,"type":16,"description":11,"interventionNames":17},"Arm B: system VULNOFAST® plus \u002F VULNOLIGHT® in addition to Usual Care","EXPERIMENTAL",[18],"Device: System VULNOFAST® plus \u002F VULNOLIGHT® in addition to Usual Care",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"OTHER","Usual Care alone","Usual Care is defined as the following procedures to apply to the foot ulcer, carried out in the order in which they are listed:\n\nSharp debridement (the debridement will be performed only if non-vital tissue is present), Mild washing of the whole ulcer with physiological solution, Treatment with topical antiseptic containing Iodopovidone, Covering with iodopovidone impregnated gauze while the ulcer is clinically infected (PEDIS ≥ 2) \\[If, during the study, PEDIS is \\\u003C 2, the ulcer will be covered with nonadherent paraffin gauze\\].\n\nTreatment 2 times a week (4 treatment weeks, 8 treatments).",[9],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"DEVICE","System VULNOFAST® plus \u002F VULNOLIGHT® in addition to Usual Care","System VULNOFAST® plus \u002F VULNOLIGHT®: VULNOFAST® plus sterile solution, in combination with a red light source VULNOLIGHT®. VULNOFAST® plus and VULNOLIGHT® will be used in accordance with their Instructions for Use (IFU) and User Manual.\n\nTreatments 2 times a week (4 treatment weeks, 8 treatments of Usual Care and 8 treatments of system VULNOFAST® plus \u002F VULNOLIGHT®).",[15],[31,37],{"name":32,"role":33,"phone":34,"phoneExt":35,"email":36},"Ilaria Corti","CONTACT","0557361193","+39","i.corti@moltenifarma.it",{"name":38,"role":33,"phone":39,"phoneExt":35,"email":40},"Laura Checcaglini","0557361194","l.checcaglini@moltenifarma.it",[42,58,70,86,99,111,123],{"facility":43,"status":44,"city":45,"state":11,"zip":11,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"U.O.C. Diabetologia e Malattie Metaboliche, Ospedale San Donato","RECRUITING","Arezzo","Italy","IT",{"type":49,"coordinates":50},"Point",[51,52],11.88068,43.46276,{"lat":52,"lon":51},[55],{"name":56,"role":33,"phone":11,"phoneExt":11,"email":57},"Alessia Scatena","alessia.scatena@uslsudest.toscana.it",{"facility":59,"status":44,"city":60,"state":11,"zip":11,"country":46,"countryCode":47,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Unit Piede Diabetico, SODc Diabetologia e Malattie del Metabolismo, Azienda Ospedaliero-Universitaria Careggi","Florence",{"type":49,"coordinates":62},[63,64],11.24626,43.77925,{"lat":64,"lon":63},[67],{"name":68,"role":33,"phone":11,"phoneExt":11,"email":69},"Matteo Monami","monamim@aou-careggi.toscana.it",{"facility":71,"status":44,"city":72,"state":11,"zip":73,"country":46,"countryCode":47,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Centro di Assistenza Vulnologica, Ospedale Villa Scassi","Genova","16149",{"type":49,"coordinates":75},[76,77],11.87211,45.21604,{"lat":77,"lon":76},[80,83],{"name":81,"role":33,"phone":11,"phoneExt":11,"email":82},"Domenico Ermirio","Domenico.Ermirio@asl3.liguria.it",{"name":84,"role":33,"phone":11,"phoneExt":11,"email":85},"Marco Marchelli","Marco.Marchelli@asl3.liguria.it",{"facility":87,"status":44,"city":88,"state":11,"zip":89,"country":46,"countryCode":47,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Unità di Diabetologia, Endocrinologia e Malattie Metaboliche, IRCSS Centro Cardiologico Monzino","Milan","20138",{"type":49,"coordinates":91},[92,93],12.59836,42.78235,{"lat":93,"lon":92},[96],{"name":97,"role":33,"phone":11,"phoneExt":11,"email":98},"Stefano Genovese","Stefano.Genovese@cardiologicomonzino.it",{"facility":100,"status":44,"city":101,"state":11,"zip":11,"country":46,"countryCode":47,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"U.O. Malattie Endocrine del Ricambio e della Nutrizione, Azienda Ospedaliero-Universitaria Policlinico Giaccone","Palermo",{"type":49,"coordinates":103},[104,105],13.3636,38.1166,{"lat":105,"lon":104},[108],{"name":109,"role":33,"phone":11,"phoneExt":11,"email":110},"Carla Giordano","carla.giordano@unipa.it",{"facility":112,"status":44,"city":113,"state":11,"zip":11,"country":46,"countryCode":47,"cosmosGeoPoint":114,"geoPoint":118,"contacts":119},"Dipartimento di Endocrinologia e Malattie Metaboliche, Centro Piede Diabetico, Ospedale S. Maria della Misericordia","Perugia",{"type":49,"coordinates":115},[116,117],12.38878,43.1122,{"lat":117,"lon":116},[120],{"name":121,"role":33,"phone":11,"phoneExt":11,"email":122},"Cristiana Vermigli","cristiana.vermigli@ospedale.perugia.it",{"facility":124,"status":44,"city":125,"state":11,"zip":11,"country":46,"countryCode":47,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"SOS Diabetologia, Presidio Ospedaliero San Jacopo","Pistoia",{"type":49,"coordinates":127},[128,129],10.92365,43.93064,{"lat":129,"lon":128},[132],{"name":133,"role":33,"phone":11,"phoneExt":11,"email":134},"Roberto Anichini","roberto.anichini@uslcentro.toscana.it",{"type":136,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100486431","photofinish-a-clinical-study-to-evaluate-the-efficacy-and-safety-of-the-system-vulnofast-plusvulnolight-in-addition-to-the-usual-care-uc-vs-uc-alone-for-the-treatment-of-infected-diabetic-foot-ulcers-100486431",false,"NCT05613985","PHOTOFINISH: a Clinical Study To Evaluate The Efficacy And Safety Of the System VULNOFAST® Plus\u002FVULNOLIGHT® In Addition To The Usual Care (UC) Vs UC Alone For The Treatment Of Infected Diabetic Foot Ulcers","A Randomised, Open-Label, Multicentre Clinical Study To Evaluate The Efficacy And Safety Of Topical Applications Of the System VULNOFAST® Plus \u002F VULNOLIGHT® In Addition To The Usual Care Versus Usual Care Alone For The Treatment Of Infected Foot Ulcers In Diabetic Patients (PHOTOFINISH)","PHOTOFINISH","Main Inclusion Criteria:\n\n* Able and willing to give voluntary written informed consent. The ICF, must be signed before any study-related procedures and\u002For assessments are performed.\n* Outpatients or inpatients (male and female) of any ethnic origin, aged 18 years or over, diagnosed with type 1 or type 2 diabetes mellitus.\n* Glycaemic control confirmed by a glycated haemoglobin (HbA1c) levels ≤10% (86 mmol\u002Fmol), evaluated in the 3 months before enrolment or at Visit 1.\n* Fasting plasma glucose (FPG) less than 300 mg\u002Fdl.\n* A chronic diabetic foot ulcer (DFU) below the malleolus, with an area ≥ 2 and ≤ 40 cm2 and with a maximum diameter\u002Flength ≤ 10 cm measured by MolecuLight i:X medical device \\[note: chronic wound is defined as a wound that, after the normal clinical practice, does not start healing within 4 weeks or does not heal within 8 weeks\\].\n* A diabetic foot wound with a depth equal or higher to grade 2 according to the category \"Depth\u002Ftissue loss\" of PEDIS, but not involving bone, diagnosed by clinical examination.\n* Presence of infected foot ulcer of grade 2 according to the category \"Infection\" of PEDIS, diagnosed by clinical examination.\n* Able to take oral medications.\n* Patients must be willing and able to comply with the protocol and study procedures.\n\nMain Exclusion Criteria:\n\n* Patients unable to give written informed consent.\n* Females who are pregnant or lactating.\n* Females who are of child bearing potential and not taking adequate contraceptive precautions are excluded from the trial. Females of child bearing potential taking acceptable contraceptive precautions can be included.\n* Participation in any other clinical trial or currently receiving any other investigational product(s) within 30 days prior to Visit 1.\n* Ankle brachial systolic blood pressure index \\\u003C 0.5 (Winsor Index) in the infected limb.\n* Ulcer probe to bone positive.\n* Any surgery planned during the study period (from ICF signature to last planned follow-up visit).\n* Clinical diagnosis of peripheral vascular disease (PVD) requiring percutaneous or surgical revascularization.\n* Transcutaneous oximetry (TcPo2) measurement \\\u003C 30 mmHg.\n* Use of any antibiotics (local or systemic) within 48h before Visit 1.\n* Patient for whom punch biopsy is contraindicated.\n* Patients that cannot take amoxicillin and clavulanic acid (background antibiotic therapy) at the dosage stated in the protocol and according to the current Summary of Product Characteristics (SPC).\n* Patients that cannot be treated with topical antiseptic containing Iodopovidone and\u002For with iodopovidone impregnated gauze according to the contraindication available in the current Summary of Product Characteristics (SPC).","ALL","18 Years",{"count":148,"type":149},78,"ESTIMATED","INTERVENTIONAL",[152],"NA","The aim of this randomised, open-label, multicentre clinical trial is to evaluate the superiority of the treatment which foresees the addition of the system VULNOFAST® plus \u002F VULNOLIGHT® to the Usual Care, versus the treatment with Usual Care alone, for the healing of chronic diabetic foot ulcer. VULNOFAST® plus is a sterile solution used in combination with a red light source VULNOLIGHT®. Usual Care is defined as procedures to apply to the foot ulcer, carried out in the order in which they are listed in the protocol.",[155],"Diabetic Foot Infection",[157,158,159,160,161,162],"Infected diabetic foot ulcer","Diabetic foot ulcer","DFU","Infected diabetic wound","Photodynamic therapy","PDT","2025-08-04",{"date":165,"type":166},"2025-08-08","ACTUAL",{"date":168,"type":166},"2021-09-14",{"date":170,"type":149},"2026-06-30",{"name":5,"class":6},7]