[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564356":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":20,"responsibleParty":34,"collaborators":36,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":42,"sex":48,"minAge":49,"maxAge":20,"enrollmentInfo":50,"targetDuration":20,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":64,"whyStopped":20,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":20},{"fullName":5,"class":6},"Mid and South Essex NHS Foundation Trust","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Cerament","EXPERIMENTAL","Cerament V\u002FG implantation to forefoot or mid foot.",[13],"Device: cerament V or G",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","cerament V or G","Cerament V or G implantation into forefoot or mid foot bone, and 7-10 days of oral antibiotics.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Ankur Thapar","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Nishita R Gadi","CONTACT","+441268 524900","nishita.gadi1@nhs.net",{"name":32,"role":28,"phone":20,"phoneExt":20,"email":33},"Georgina Beeter","Georgina.Beetar@nhs.net",{"type":35,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[37],{"name":38,"class":39},"BONESUPPORT AB","INDUSTRY","100564356","post-market-study-of-cerament-vg-in-pedal-osteomyelitis-100564356",false,"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","ALL","18 Years",{"count":51,"type":52},25,"ESTIMATED","INTERVENTIONAL",[55],"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.",[58],"Osteomyelitis - Foot",[60,61,62,63],"osteomyelitis","antimicrobial","bone void filler","cerament","NOT_YET_RECRUITING","2024-10-03",{"date":67,"type":68},"2024-10-04","ACTUAL",{"date":70,"type":52},"2024-10-01",{"date":72,"type":52},"2026-11-01",{"name":5,"class":6}]