[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100260079":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":124,"collaborators":126,"id":130,"slug":131,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":132,"sex":138,"minAge":139,"maxAge":26,"enrollmentInfo":140,"targetDuration":26,"studyType":143,"phases":144,"briefSummary":147,"conditions":148,"keywords":151,"overallStatus":153,"whyStopped":26,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"Centre Hospitalier Universitaire de Nīmes","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Phage therapy","EXPERIMENTAL","Patients randomized to this arm will have phage therapy.\n\nIntervention: Topical anti-Staphylococcus bacteriophage therapy",[13],"Drug: Topical anti-Staphylococcus bacteriophage therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Patients randomized to this arm will have placebo therapy anologous to that of the experimental arm.\n\nIntervention: Topical placebo corresponding to anti-Staphylococcus bacteriophage therapy",[19],"Drug: Topical placebo corresponding to anti-Staphylococcus bacteriophage therapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Topical anti-Staphylococcus bacteriophage therapy","Patients randomized to the experimental arm will receive sterile compress dressings impregnated with a phage solution of 10\\^7 PFU\u002Fml on days 0, 7 and 14 (unless the wound is already healed, i.e. phage solutions are not applied to healed wounds).",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Topical placebo corresponding to anti-Staphylococcus bacteriophage therapy","Patients randomized to the placebo arm will receive sterile compress dressings impregnated with a placebo solution on days 0, 7 and 14 (unless the wound is already healed, i.e. placebo solutions are not applied to healed wounds).",[15],[32],{"name":33,"affiliation":5,"role":34},"Albert Sotto, MD, PhD","STUDY_DIRECTOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+33.(0)6.09.56.66.55","albert.sotto@chu-nimes.fr",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},"Christophe Masseguin, PhD","+33.(0)4.66.68.68.36","christophe.masseguin@chu-nimes.fr",[45,61,73,88,100,112],{"facility":46,"status":26,"city":47,"state":26,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"CHU de Bordeaux - Hôpital Pellegrin","Bordeaux","33000","France","FR",{"type":52,"coordinates":53},"Point",[54,55],-0.58046,44.84124,{"lat":55,"lon":54},[58],{"name":59,"role":60,"phone":26,"phoneExt":26,"email":26},"Antoine Dauchy, MD, PhD","PRINCIPAL_INVESTIGATOR",{"facility":62,"status":26,"city":63,"state":26,"zip":64,"country":49,"countryCode":50,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"CHRU de Nîmes - Hôpital Universitaire de Réadaptation du Grau du Roi","Le Grau-du-Roi","30240",{"type":52,"coordinates":66},[67,68],4.13559,43.53881,{"lat":68,"lon":67},[71],{"name":72,"role":60,"phone":26,"phoneExt":26,"email":26},"Sophie Schuldiner, MD",{"facility":74,"status":26,"city":75,"state":26,"zip":76,"country":49,"countryCode":50,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Hopital européen","Marseille","13003",{"type":52,"coordinates":78},[79,80],5.38107,43.29695,{"lat":80,"lon":79},[83,86],{"name":84,"role":37,"phone":26,"phoneExt":26,"email":85},"Stanislas Rebaudet, MD, PhD","s.rebaudet@hopital-europeen.fr",{"name":87,"role":60,"phone":26,"phoneExt":26,"email":26},"Stanislad Rebaudet, MD, PhD",{"facility":89,"status":26,"city":90,"state":26,"zip":91,"country":49,"countryCode":50,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"CHRU de Toulouse - Hôpital de Rangueil","Toulouse","31059",{"type":52,"coordinates":93},[94,95],1.44367,43.60426,{"lat":95,"lon":94},[98],{"name":99,"role":60,"phone":26,"phoneExt":26,"email":26},"Jacques Martini, MD",{"facility":101,"status":26,"city":102,"state":26,"zip":103,"country":49,"countryCode":50,"cosmosGeoPoint":104,"geoPoint":108,"contacts":109},"CH de Tourcoing","Tourcoing","59200",{"type":52,"coordinates":105},[106,107],3.16117,50.72391,{"lat":107,"lon":106},[110],{"name":111,"role":60,"phone":26,"phoneExt":26,"email":26},"Benoit Gachet, MD, PhD",{"facility":113,"status":26,"city":114,"state":26,"zip":115,"country":49,"countryCode":50,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"CH Intercommunal de Villeneuve-Saint-Georges","Villeneuve-Saint-Georges","94195",{"type":52,"coordinates":117},[118,119],2.44925,48.73219,{"lat":119,"lon":118},[122],{"name":123,"role":60,"phone":26,"phoneExt":26,"email":26},"Pauline CARAUX-PAZ, MD",{"type":125,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[127],{"name":128,"class":129},"Phagenix","INDUSTRY","100260079","phase-1-standard-treatment-associated-with-phage-therapy-versus-placebo-for-diabetic-foot-ulcers-infected-by-s-aureus-100260079",false,"NCT02664740","Standard Treatment Associated With Phage Therapy Versus Placebo for Diabetic Foot Ulcers Infected by S. Aureus","Comparison of the Efficacy of Standard Treatment Associated With Phage Therapy Versus Standard Treatment Plus Placebo for Diabetic Foot Ulcers Monoinfected by Staphylococcus Aureus: a Randomized, Multi-centre, Controlled, 2-parallel-group, Double-blind, Superiority Trial","PhagoPied","Participant pre-inclusion criteria:\n\n* The patient must have given his\u002Fher informed and signed consent\n* The patient must be insured or beneficiary of a health insurance plan\n* The patient is at least 18 years old\n* The patient has type 1 or type 2 diabetes\n* The patient is hospitalized\u002Fconsulting in a participating centre\n* The patient has a wound below the ankle that has be evolving for \\>2 weeks\n* The patient has a neuropathic foot wound, classified S (0 or 1), I (0 or 1), N (1), B (1), A (0 or1) and D (1) according to the SINBAD classification,\n\n  * without ischaemia or with non-critical ischaemia defined by: ankle arterial pressure \\> 50 mm Hg or toe systolic arterial pressure \\> 30 mm Hg or TcpO2 \\> 30 mm Hg )\n  * with a surface area ≥ 0,5 cm2\n  * With IWGDF\u002FIDSA grade 2 or 3 infection without osteomyelitis (normal radiography\\*)\n* Females of childbearing potential or Sexually active males with partner of childbearing potential: commitment to consistently and correctly use an acceptable method of birth control (oral, transdermal, systemic or implant contraception birth control, intrauterine devices) for 1 month after the last study drug administration\n* Negative pregnancy test must be obtained before starting any experimental drug\n* Females of non-childbearing potential: either surgically sterilized or at least 1 year postmenopausal (amenorrhea duration at least 12 months)\n\nParticipant final inclusion criteria:\n\n* The patient has a neuropathic foot wound:\n\n  * Classified S (0 or 1), I (0 or 1), N (1), B (1), A (0 or1) and D (1) according to the SINBAD classification,\n* without ischaemia or with non-critical ischaemia defined by: ankle arterial pressure \\> 50 mm Hg or toe systolic arterial pressure \\> 30 mm Hg or TcpO2 \\> 30 mm Hg )\n* with a surface area ≥ 0,5 cm2\n\n  * With IWGDF\u002FIDSA grade 2 or 3 infection without osteomyelitis\n* The patient's wound is monoinfected by methicillin-resistant or susceptible S. aureus (MSSA or MRSA ), or infected by MSSA or MRSA and other bacteria (a total of 3 bacteria when accounting for MSSA or MRSA)\n* The Phagogram of the patient demonstrated that the strains are susceptible to at least one phage(PP1493 and\u002For PP1815).\n\nParticipant pre-exclusion criteria:\n\n* The patient is participating in, or has participated in over the past three months, another trial\n* The patient is participating in, or has participated in over the past three months, another study that may interfere with the results or conclusions of this study\n* The patient is in an exclusion period determined by a previous study\n* The patient is under judicial protection, or is an adult under guardianship\n* It is impossible to correctly inform the patient\n* The patient refuses to sign the consent\n* The patient is pregnant, parturient or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the treatment period and 1 month after the last administration of study drug\n* Women\u002FMen refusing to use an effective contraception during and1 month after the last administration of study drug\n\nParticipant final exclusion criteria:\n\n* The patient refuses to participate to the study\n* The patient is pregnant, parturient or breastfeeding. Patients should not be enrolled if they plan to become pregnant during the treatment period and 1 month after the last administration of study drug\n* Women\u002FMen refusing to use an effective contraception during and1 month after the last administration of study drug\n* Patients with diabetic foot wounds associated with clinical or radiographic signs of arthritis or osteomyelitis\\*\n* Patient is not infected by S. aureus or infected by more than 3 bacteria even if the culture isolates a S. aureus.","ALL","18 Years",{"count":141,"type":142},60,"ESTIMATED","INTERVENTIONAL",[145,146],"PHASE1","PHASE2","The primary objective of this study is to compare the efficacy of standard treatment associated with a topical anti-staphylococcal bacteriophage cocktail versus standard treatment plus placebo for diabetic foot ulcers monoinfected by methicillin-resistant or susceptible S. aureus (MRSA or MSSA) as measured by the relative reduction in wound surface area (%) at 12 weeks.",[149,150],"Diabetic Foot","Staphylococcal Infections",[152],"Phage Therapy","NOT_YET_RECRUITING","2026-03-18",{"date":156,"type":157},"2026-03-20","ACTUAL",{"date":159,"type":142},"2026-09-01",{"date":161,"type":142},"2028-11",{"name":5,"class":6},6]