[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100537911":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":41,"responsibleParty":222,"collaborators":224,"id":227,"slug":228,"hasResults":229,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":229,"sex":235,"minAge":236,"maxAge":26,"enrollmentInfo":237,"targetDuration":26,"studyType":240,"phases":241,"briefSummary":243,"conditions":244,"keywords":247,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":261},{"fullName":5,"class":6},"Biocomposites Ltd","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Interventional STIMULAN VG","EXPERIMENTAL","Ulcer bursectomy and debridement and STIMULAN VG insertion into the ulcer cavity.\n\nFlap\u002Fprimary closure. Peri-operative antibiotics.",[13,14],"Combination Product: STIMULAN VG","Procedure: Standard of Care",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard of Care (SoC)","ACTIVE_COMPARATOR","Ulcer bursectomy, debridement and flap\u002Fprimary closure. Peri-operative antibiotics.",[14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"COMBINATION_PRODUCT","STIMULAN VG","Insertion of STIMULAN VG into the ulcer cavity prior to flap\u002Fprimary closure.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Standard of Care","Standard of Care. Ulcer bursectomy, debridement and flap\u002Fprimary closure. Peri-operative antibiotics.",[9,16],[33,38],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Keira Watts, Clinical Research Director","CONTACT","+44 (0) 1782 338 580","clinicaltrials@biocomposites.com",{"name":39,"role":35,"phone":26,"phoneExt":26,"email":40},"Daniel Roberts","droberts@mcra.com",[42,67,87,106,125,144,163,182,202],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Advanced Foot Care, LLC","RECRUITING","Phoenix","Arizona","85032","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-112.07404,33.44838,{"lat":54,"lon":53},[57,61,64],{"name":58,"role":35,"phone":59,"phoneExt":26,"email":60},"Krishna Sai Penumarthi","(480) 863-6044","kspenumarthi@axentrabio.com",{"name":62,"role":35,"phone":59,"phoneExt":26,"email":63},"Rajashekhar Ittedi","rajaittedi123@gmail.com)",{"name":65,"role":66,"phone":26,"phoneExt":26,"email":26},"Jaminelli Banks, DPM","PRINCIPAL_INVESTIGATOR",{"facility":68,"status":44,"city":69,"state":70,"zip":71,"country":48,"countryCode":49,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Northwestern University Feinberg School of Medicine","Chicago","Illinois","60611",{"type":51,"coordinates":73},[74,75],-87.65005,41.85003,{"lat":75,"lon":74},[78,82,85],{"name":79,"role":35,"phone":80,"phoneExt":26,"email":81},"Brigid Coles","312-503-3209","brigid.coles@nm.org",{"name":83,"role":35,"phone":80,"phoneExt":26,"email":84},"Tarifa Adam","tarifa.adam@nm.org",{"name":86,"role":66,"phone":26,"phoneExt":26,"email":26},"Robert Galiano, MD",{"facility":88,"status":44,"city":89,"state":90,"zip":91,"country":48,"countryCode":49,"cosmosGeoPoint":92,"geoPoint":96,"contacts":97},"Henry Ford Hospital","Detroit","Michigan","48202",{"type":51,"coordinates":93},[94,95],-83.04575,42.33143,{"lat":95,"lon":94},[98,101,104],{"name":99,"role":35,"phone":26,"phoneExt":26,"email":100},"Dan Molitor","dmolito2@hfhs.org",{"name":102,"role":35,"phone":26,"phoneExt":26,"email":103},"Sarah Meehan","smeehan1@hfhs.org",{"name":105,"role":66,"phone":26,"phoneExt":26,"email":26},"Aamir Siddiqui, MD",{"facility":107,"status":44,"city":108,"state":109,"zip":110,"country":48,"countryCode":49,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"University of Mississippi Medical Center","Jackson","Mississippi","39216",{"type":51,"coordinates":112},[113,114],-90.18481,32.29876,{"lat":114,"lon":113},[117,120,123],{"name":118,"role":35,"phone":26,"phoneExt":26,"email":119},"Venkata Seerapu","vseerapu@umc.edu",{"name":121,"role":35,"phone":26,"phoneExt":26,"email":122},"Laxmi Dhungel","idhungel@umc.edu",{"name":124,"role":66,"phone":26,"phoneExt":26,"email":26},"Ian Hoppe, MD",{"facility":126,"status":44,"city":127,"state":128,"zip":129,"country":48,"countryCode":49,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Missouri Orthopaedic Institute","Columbia","Missouri","65201",{"type":51,"coordinates":131},[132,133],-92.33407,38.95171,{"lat":133,"lon":132},[136,139,142],{"name":137,"role":35,"phone":26,"phoneExt":26,"email":138},"Andrew Monhollen","am5hf@health.missouri.edu",{"name":140,"role":35,"phone":26,"phoneExt":26,"email":141},"Vicki Jones","jonesvicki@health.missouri.edu",{"name":143,"role":66,"phone":26,"phoneExt":26,"email":26},"Brett Crist, MD",{"facility":145,"status":44,"city":146,"state":147,"zip":148,"country":48,"countryCode":49,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"University of Nebraska Medical Center","Omaha","Nebraska","68198",{"type":51,"coordinates":150},[151,152],-95.94043,41.25626,{"lat":152,"lon":151},[155,158,161],{"name":156,"role":35,"phone":26,"phoneExt":26,"email":157},"Katie Ostlund","katie.ostlund@unmc.edu",{"name":159,"role":35,"phone":26,"phoneExt":26,"email":160},"Gabriel Gauthier","gabriel.gauthier@unmc.edu",{"name":162,"role":66,"phone":26,"phoneExt":26,"email":26},"James Willcockson, MD",{"facility":164,"status":44,"city":165,"state":166,"zip":167,"country":48,"countryCode":49,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Rutgers New Jersey Medical School","Newark","New Jersey","07103",{"type":51,"coordinates":169},[170,171],-74.17237,40.73566,{"lat":171,"lon":170},[174,177,180],{"name":175,"role":35,"phone":26,"phoneExt":26,"email":176},"Saharsh Patel","ssp186@gsbs.rutgers.edu",{"name":178,"role":35,"phone":26,"phoneExt":26,"email":179},"Mehreen Bhatti","mb2276@njms.rutgers.edu",{"name":181,"role":66,"phone":26,"phoneExt":26,"email":26},"Alex Wong, MD, FACS",{"facility":183,"status":44,"city":184,"state":185,"zip":186,"country":48,"countryCode":49,"cosmosGeoPoint":187,"geoPoint":191,"contacts":192},"NYU Langone Hospital - Long Island Clinical Research Center","Mineola","New York","11501",{"type":51,"coordinates":188},[189,190],-73.64068,40.74927,{"lat":190,"lon":189},[193,197,200],{"name":194,"role":35,"phone":195,"phoneExt":26,"email":196},"Anita Farha","516 663 9582","anita.farhi@nyulangone.org",{"name":198,"role":35,"phone":195,"phoneExt":26,"email":199},"Monica Benitez","monica.benitez@nyulangone.org",{"name":201,"role":66,"phone":26,"phoneExt":26,"email":26},"Scott Gorenstein, MD",{"facility":203,"status":44,"city":204,"state":205,"zip":206,"country":48,"countryCode":49,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"University of Pittsburgh, McGowan Institute for Regenerative Medicine","Pittsburgh","Pennsylvania","15219",{"type":51,"coordinates":208},[209,210],-79.99589,40.44062,{"lat":210,"lon":209},[213,217,220],{"name":214,"role":35,"phone":215,"phoneExt":26,"email":216},"Urmila Gnyawali","412-624-5500","usg2@pitt.edu",{"name":218,"role":35,"phone":215,"phoneExt":26,"email":219},"Scot King","scot.king@pitt.edu",{"name":221,"role":66,"phone":26,"phoneExt":26,"email":26},"Sashwati Roy, PhD, MS",{"type":223,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[225],{"name":226,"class":6},"MCRA","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",false,"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","ALL","18 Years",{"count":238,"type":239},60,"ESTIMATED","INTERVENTIONAL",[242],"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.",[245,246],"Pressure Ulcer, Stage IV","Osteomyelitis",[248,249,250,251],"between-group effect size","surgical debridement","ulcer bursectomy","systemic antibiotics","2026-05-01",{"date":254,"type":255},"2026-05-06","ACTUAL",{"date":257,"type":255},"2025-06-15",{"date":259,"type":239},"2026-12-01",{"name":5,"class":6},9]