[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":48},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"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":20,"type":21},78,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Diabetic Foot Infection",[29,30,31,32,33,34],"Infected diabetic foot ulcer","Diabetic foot ulcer","DFU","Infected diabetic wound","Photodynamic therapy","PDT","RECRUITING","2025-08-04",{"date":38,"type":39},"2025-08-08","ACTUAL",{"date":41,"type":39},"2021-09-14",{"date":43,"type":21},"2026-06-30",{"name":45,"class":46},"L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.","INDUSTRY",7,""]