[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"osteomyelitis---foot\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:osteomyelitis---foot":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,76],{"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":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100613450","phase-4-comparison-of-oral-antibiotics-for-bone-infections-of-the-leg-and-foot-100613450",false,"NCT07266753","Comparison of Oral Antibiotics For Bone Infections of the Leg and Foot","Oral Beta-lactams Versus Non-beta-lactamS for Treatment of Lower Extremity Osteomyelitis","OSTEO","Inclusion Criteria:\n\n1. Adult (\\> 18 years old)\n2. OM of the lower extremity (below the knee) as determined by the treating healthcare provider (clinically and\u002For radiographically)\n3. Expected duration of treatment at least 28 additional days of antibiotic therapy for the infection episode, from the time of enrolment\n4. Treating health care team has already transitioned or is willing to transition to oral antibiotic therapy for the remainder of the treatment duration\n\nExclusion Criteria:\n\n1. Prior enrolment in the OSTEO trial\n2. Already received more than 14 days of uninterrupted antibiotic treatment for this episode of OM\n3. No beta-lactam or non-beta-lactam option due to any of:\n\n   1. Allergy\n   2. Suspected or confirmed antimicrobial resistance\n   3. Medical contraindications\n   4. Non-modifiable drug-drug interaction risk\n4. Need to receive combination antibiotic therapy with both beta-lactam and non-beta-lactam, with the exception of metronidazole and rifampin\n5. Prior antibiotic treatment for the same infection in the past 6 months\n6. Known pregnancy, planning to become pregnant during the study period, or breastfeeding","ALL","18 Years",{"count":20,"type":21},1418,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The goal of this clinical trial is to compare different classes of oral antibiotics (beta-lactam and non-beta-lactam antibiotics) for the treatment of bone infections of the leg and foot. The hypothesis is that oral beta-lactam antibiotics work as well as oral non-beta-lactam antibiotics to treat these infections. The first step is to assess whether it is possible to perform the trial by determining whether participants can be recruited and followed successfully. If the trial is proven to be possible, it will be expanded to ensure an answer to whether the two antibiotic classes work as well for the treatment of bone infections of the leg and foot.",[27,28,29],"Osteomyelitis of Lower Extremities","Osteomyelitis - Foot","Osteomyelitis of the Foot",[31,32,33,34],"Osteomyelitis","Bone Infection","Lower Extremity","Oral beta-lactams versus non-beta-lactams","RECRUITING","2026-03-23",{"date":38,"type":39},"2026-03-27","ACTUAL",{"date":41,"type":39},"2026-02-26",{"date":43,"type":21},"2033-12-31",{"name":45,"class":46},"Michael Garron Hospital","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100564356","post-market-study-of-cerament-vg-in-pedal-osteomyelitis-100564356","NCT06628115","Post Market Study of Cerament V\u002FG in Pedal Osteomyelitis","Post-market Study of Cerament V\u002FG in Foot Osteomyelitis","Cerament 2","Inclusion Criteria:\n\n* 18 years +\n* Informed consent\n* Operated on for foot sepsis with limb salvage intent.\n* Positive bone biopsy from forefoot or midfoot or positive pus culture from exposed bone\n* Adequate vascularity (1+ palpable pedal pulse, biphasic or triphasic ankle waveforms, or successful revascularisation procedure same admission)\n* Compliant with offloading footwear and diabetic medication\n\nExclusion Criteria:\n\n* Allergy or contraindication to gentamicin\u002Fvancomycin\n* Life expectancy \\&amp \\<1 year\n* Unable to make follow up appointments at study centre.\n* Patients with necrotizing infections\n* Gentamicin or vancomycin resistant organism\n* Untreated peripheral arterial disease in angiosome of wound.\n* Buerger's disease\n* Vasculitides\n* Systemic immunosuppressive therapy\n* Pregnancy\n* Breastfeeding\n* Untreated thyrotoxicosis\n* Mysathenia gravis\n* Calcium metabolism disorder\n* Patients taking metformin with estimated glomerular filtration rate (eGFR) \\> 30ml\u002Fmin\u002F1.72m2",{"count":56,"type":21},25,[58],"NA","The goal of this clinical trial is to look at the outcomes of patients who have had bone infection of their feet treated with a licensed antibiotic paste. The main question it aims to answer is:\n\n• How does the bone infection heal in response to the antibiotic paste?\n\nParticipants will:\n\n* Undergo standard surgery to remove dead bone and drain any pus.\n* Antibiotic paste is injected directly into the middle of the bone at surgery. This is instead of receiving antibiotics directly into their bloodstream for 6 weeks.\n* Recieve one week of tablet antibiotics.\n* Visit clinic 1 month after surgery for a normal clinical appointment. After, a research team member will ask the participant a few questions. The participant will also have a foot x-ray, wound photograph and fill out a short questionnaire.\n* Visit clinic 6 months and 12 months following the surgery. A research team member will ask the participant a few questions. The participant will also have a foot x-ray, wound photograph and fill out a short questionnaire.",[28],[62,63,64,65],"osteomyelitis","antimicrobial","bone void filler","cerament","NOT_YET_RECRUITING","2024-10-03",{"date":69,"type":39},"2024-10-04",{"date":71,"type":21},"2024-10-01",{"date":73,"type":21},"2026-11-01",{"name":75,"class":46},"Mid and South Essex NHS Foundation Trust",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100545951","rct-on-bioactive-glass-s53p4-in-diabetic-foot-osteomyelitis-in-the-forefoot-dforct-100545951","NCT06388603","RCT on Bioactive Glass S53P4 in Diabetic Foot Osteomyelitis in the Forefoot (DFORCT)","A National, Prospective, Randomized, Multicenter, Controlled Comparison of Bioactive Glass S53P4 Versus Standard of Care Treatment of Diabetic Foot Osteomyelitis in the Forefoot","DFORCT","Inclusion Criteria:\n\n1. Written informed consent obtained.\n2. Male or female patients \\>= of 18 years old.\n3. They should have type I since at least 5 years or type II DM\n4. They should have a diagnosis - confirmed by imaging and culture - of OM localized in the forefoot not responding for at least 2 up to 6 weeks to systemic antibiotic therapy and\u002For associated with soft tissue infection, abscess, phlegmon, necrosis, and for which a surgical debridement is indicated.\n5. They should have palpable pulses on TP or DP at the ankle in the affected limb, and\u002For ABPI \\>0.7 and \\\u003C1.2 and \u002For TcPO2 at dorsum of the foot ≥36 mmHg.\n6. They should be able to accomplish with the procedures and prescriptions indicated by the Study protocol, particularly with the offloading prescription, as well as they should be willing and able to attend and respect the program of control visits and medications.\n7. Anatomical area: forefoot.\n\nExclusion Criteria:\n\n1. They should not have metabolic decompensation as witnessed by HbA1c \\>109 mmol\u002Fmol (\\> 12%).\n2. They should not have major amputation on the contra-lateral limb.\n3. They should not have acute or chronic Charcot's foot in the affected foot.\n4. They should not have undergone surgical or endovascular revascularization in the affected foot in the month preceding the enrollment.\n5. They should not be taking corticosteroids, bisphosphonates, immunosuppressants, and more in general any drug which might interfere with bone metabolism or tissue repair, in thejudgment of investigators.\n6. They should not have ESRD in dialysis.\n7. They should not be bedridden or not ambulating.\n8. They should not have a life expectancy shorter than one year.\n9. They should not be too ill to sustain a surgical procedure under loco-regional anesthesia.\n10. They should not have severe disease which might interfere with the expected course of the disease and therapy.\n11. Hypersensitivity to any product ingredient(s) or history of anaphylactic reactions.\n12. Participation in another interventional studies within 45 days prior to the start of the present study.\n13. Predictable poor compliance or inability to communicate well with the investigator.","100 Years",{"count":86,"type":21},140,[58],"The Study will be a prospective multicenter randomized trial, focused on the management of acute and chronic Osteomilytis in Diabetic Foot patients. The aim of this Study will be to compare the effectiveness and safety of S53P4 bioactive glass, medical device class III used as per its CE mark indication and Instruction For Use, in the surgical management of OM in the forefoot performed as per local surgical standard of care, in the same indications in a group of Diabetic Foot patients admitted in highly specialized dedicated centers.\n\nParticipants will randomized into two groups:\n\n* Patients in Group A will be treated with surgical removal of the affected bone, debridement of infected soft tissues and systemic antibiotic therapy targeted on the sampling on the bone during the surgical procedure, with or without use of bone substitutes (with the only exception of Bioactive glasses) according to the judgement of the operator as per normal practice.\n* Patients in Group B will be debrided as well and the infected bone will be debrided without eliminating completely the structure of the bone, but instead preserving the cortex, while all the soft bone visibly infected will be removed and then replaced with Bioactive glass, as per IFU, (S53P4 - Bonalive® granules and putty, Bonalive Biomaterials Ltd. Finland) and then closed for primary intention whenever possible.",[28],[91,31,92],"Diabetic Foot","Forefoot","2024-04-24",{"date":95,"type":39},"2024-04-29",{"date":97,"type":39},"2024-03-21",{"date":99,"type":21},"2026-12-30",{"name":101,"class":46},"ASST Ovest Milanese",7]