[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Biocomposites Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":95},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,78],{"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":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100613729","antibiotic-device-for-osteomyelitis-of-the-extremities-pivotal-trial---genex-with-gentamicin-100613729",false,"NCT07270380","Antibiotic Device for Osteomyelitis of the Extremities Pivotal Trial - Genex With Gentamicin.","A Multi-center, Single-arm, Historically Controlled Pivotal Trial, to Assess the Safety and Effectiveness of Genex G as Part of the Surgical Treatment of Osteomyelitis of the Extremities.","ADOPT GG","Inclusion Criteria:\n\n1. Patient with osteomyelitis of the extremities, who have failed antibiotic therapy and are requiring surgical intervention (unresolved osteomyelitis), Cierny-Mader classification of osteomyelitis grades I-IV. Patients presenting with Cierny-Mader grades I-II will be required to have a defect created as part of debridement surgery\n2. Patients at least 18 years of age \\*1\n3. Patient willing and able to provide written informed consent\n4. Patient geographically stable and able to comply with the required follow-up visits and testing schedule as assessed by the investigator\n5. Ability to achieve adequate surgical soft tissue coverage of the wound (primary tissue closure or surgical reconstruction including local and free soft tissue transfer)\n\n   * 1 Patients between 18 and 22 years of age require confirmation of skeletal maturity as validated by radiographs of the bone to be treated.\n\nExclusion Criteria:\n\n1. Patients diagnosed with acute osteomyelitis\n2. Patients with Cierny-Mader grades I-II who are unable to have a defect created during debridement surgery\n3. Renal failure or documented chronic kidney disease with serum creatinine ≥3.5 mg\u002FdL (309umol\u002FL) or being treated with dialysis\n4. Participants with a terminal or palliative diagnosis (e.g. terminal cancer diagnosis) deemed to have less than 1 year life expectancy by their health care team\n5. Uncontrolled diabetes mellitus (hemoglobin A1c levels \\>10%)\n6. Pre-existing calcium metabolism disorder\n7. Women who are pregnant or breastfeeding or planning on becoming pregnant during the study (a pregnancy test will be done in women of childbearing potential at screening and on the day of surgery)\n8. History of hypersensitivity or contraindication to the investigational device or any of its ingredients (calcium phosphate, β-tricalcium phosphate, and aminoglycoside antibiotics)\n9. Participation in an investigational drug\u002Fdevice study (within the last 60 days) or prior enrolment to the ADOPT GG study\n10. Clinically significant or unstable medical or surgical condition that in the investigators opinion may preclude safe and complete study participation (for example patients medically unfit for surgery, general anesthesia, or any risk of significant blood loss resulting in significant risk to loss of life)\n11. Current untreated malignant neoplasm(s), or current treatment with radiation therapy or chemotherapy\n12. Current or recent history (within last 2 years) of active substance abuse (e.g. recreational drugs, narcotics, or alcohol) that meets DSM-5 severe criteria\n13. Current user of any products containing nicotine\n14. Currently incarcerated","ALL","18 Years",{"count":20,"type":21},139,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this trial is to determine if genex with gentamicin (genex G) an antibiotic loaded bone void filler, works to treat and is a safe option as part of the surgical treatment of osteomyelitis in the extremities.",[27],"Osteomyelitis",[29,30,31,32,33,34,35],"Single Arm","Historical Control","Pivotal Device Study","Bone Void Filler","Gentamicin","Systemic Antibiotics","genex","RECRUITING","2026-06-17",{"date":39,"type":40},"2026-06-18","ACTUAL",{"date":42,"type":21},"2026-06",{"date":44,"type":21},"2028-10",{"name":46,"class":47},"Biocomposites Ltd","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100537911","phase-2-a-randomized-controlled-phase-ii-trial-of-stimulan-vg-vs-standard-of-care-soc-for-the-treatment-of-osteomyelitis-associated-with-stage-iv-pressure-ulcers-100537911","NCT06283979","A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.","A Multi-center, Randomized (1:1), Controlled Phase II Trial of STIMULAN VG With Debridement and a Course of Systemic Antibiotics vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.","BLADE OPU2","In order to be eligible to participate in this study, subjects must meet all of the following criteria:\n\n1. Presenting with a Stage IV pressure ulcer requiring treatment of excision, bony debridement and flap coverage\u002Fprimary closure.\n2. Operative candidate for flap surgery or primary closure.\n3. Presence of focal osteomyelitis as suggested by imaging to show extent of infection. Acceptable imaging techniques are Magnetic Resonance Imaging or CT scan.\n4. Adults ≥ 18 years in age at the time of treatment.\n5. Psychosocially, mentally, and physically able to fully comply with this protocol, including adhering to scheduled visits, treatment plan, completing forms, and other study procedures.\n6. Ability of the subject or legal authorized representative to provide voluntary, signed and dated informed consent prior to any study-related procedures.\n\nSubjects who meet any of the following criteria will be excluded from participating in this study:\n\n1. Reasons contributing to pressure ulcer cannot be addressed.\n2. Severe immunological compromised patients as determined by the clinician.\n3. Patients with diffuse or widespread pelvic osteomyelitis that is not amenable to adequate margins for debridement.\n4. Patients presenting with head pressure ulcers.\n5. Current or recent history (within last 2 years) of active substance abuse (e.g., recreational drugs, narcotics, or alcohol) that in the judgement of the investigator, may compromise the participant's safety\u002Frecovery or ability to follow the trial procedures.\n6. Current smoker.\n7. Diabetic patient with Hba1C level above 9.\n8. Allergy to any component of the investigational product, such as calcium sulfate, glycopeptide antibiotics (Vancomycin), or aminoglycoside antibiotics (Gentamicin).\n9. Concurrent involvement in a study of another investigational product.\n10. Pregnant or planning to become pregnant during study period.\n11. Flexion contractures where patient cannot passively get full extension.\n12. Uncontrolled muscle spasms.\n13. Unable to comply with bedrest restriction or offloading requirements\n14. Unable to provide consent.\n15. Fecal or urinary incontinence with contamination of the wound.\n16. Lower extremity pressure ulcer location that is vascularly compromised as defined by an Ankle Brachial Index ≤ 0.7 mm Hg OR toe brachial index ≤ 0.6 mm OR toe pressure ≤ 40 mm Hg OR transcutaneous oximetry ≤ 40 mm Hg \\*\n17. Investigator considers the participant to be clinically malnourished.\n18. Any conditions with known hypercalcemia (\\> 10.3 mg\u002Fdl) or posing a significant risk for developing hypercalcemia (i.e., Hyperparathyroidism).\n19. Investigator believes trial participation may compromise safety of the participant or trial results.\n\n    * Patients presenting with lower extremity pressure ulcers that are vascularly compromised can be rescreened followed successful revascularization",{"count":58,"type":21},60,[60],"PHASE2","The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only) for the treatment of osteomyelitis associated stage IV pressure ulcers.",[63,27],"Pressure Ulcer, Stage IV",[65,66,67,68],"between-group effect size","surgical debridement","ulcer bursectomy","systemic antibiotics","2026-05-01",{"date":71,"type":40},"2026-05-06",{"date":73,"type":40},"2025-06-15",{"date":75,"type":21},"2026-12-01",{"name":46,"class":47},9,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":94,"locationsCount":4},"100578228","expanded-access-program-eap-stimulan-vg-100578228","NCT06808568","Expanded Access Program (EAP) STIMULAN VG","EAPSTIMVG","Inclusion Criteria:\n\n\\-\n\nExclusion Criteria:\n\n\\-","EXPANDED_ACCESS","Individual (single) patient expanded access may be considered.",[88,89],"Stage IV Pressure Ulcer","Diabetic Foot Osteomyelitis","AVAILABLE","2025-01-29",{"date":93,"type":40},"2025-02-05",{"name":46,"class":47},""]