[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"osteomyelitis-chronic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:osteomyelitis-chronic":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100643995","phase-2-efficacy-and-safety-of-zoledronate-versus-placebo-on-pain-at-week-12-in-pediatric-patients-with-chronic-recurrent-multifocal-osteomyelitis-100643995",false,"NCT07668583","EFFICACY AND SAFETY OF ZOLEDRONATE VERSUS PLACEBO ON PAIN AT WEEK 12 IN PEDIATRIC PATIENTS WITH CHRONIC RECURRENT MULTIFOCAL OSTEOMYELITIS","EFFICACY AND SAFETY OF ZOLEDRONATE VERSUS PLACEBO ON PAIN AT WEEK 12 IN PEDIATRIC PATIENTS WITH CHRONIC RECURRENT MULTIFOCAL OSTEOMYELITIS RESISTANT TO NON-STEROIDAL ANTI-INFLAMMATORY DRUG","POMREP","Inclusion Criteria:\n\n* aged ≥4 and \\\u003C17 years for whom:\n* Physician-confirmed diagnosis of CRMO according to Jansson's criteria, with compatible MRI findings. Having lesions on MRI within 12 weeks prior to inclusion and clinically active disease defined by at least one of 2 criteria: patient\u002Fparent VAS (pain) superior or equal to 30\u002F100 and\u002For physician VAS superior or equal to 30\u002F100 after failure of at least 4 weeks of NSAIDs at a stable dose\n* Written informed consent signed by the parents (the child may sign the consent if they wish, but their signature is not mandatory)\n* Having had a dental review within 3 months prior to inclusion, with completion of any necessary invasive dental work before the first dose of zoledronate.\n\nExclusion Criteria:\n\n* History of malignancy or current tumour\n* History of seizure\n* Current infectious osteomyelitis\n* Contraindication to the study drug\n* Hypersensitivity to the active substance, to other bisphosphonates, or to any excipient (sodium hydroxide, hydrochloric acid for pH adjustment, water for injection) ;\n* Hypocalcemia ;\n* Severe renal impairment with creatinine clearance \\\u003C 35 ml\u002Fmin ;\n* Prior treatment with bisphosphonates and\u002For biotherapy within 6 months prior to inclusion.\n* History of HIV, HBV, or HCV infection.\n* Congenital or acquired prolonged QT interval (\\>0.44 seconds) on ECG.\n* Clinically significant vertebral deformities, including vertebral fracture and\u002For angular kyphosis with risk of spinal cord compression.\n* Suspected or confirmed tuberculosis.\n* History of renal or hepatic insufficiency.\n* Already enrolled in another interventional study.\n* Pregnant or breastfeeding participants\n* Not affiliated with the French social security system.\n* Patient or legal guardians with limited understanding of the French language\n* Serum 25-hydroxy vitamin D level \\\u003C30 ng\u002FmL at screening. Participants may be re-screened after correction of vitamin D deficiency.","ALL","4 Years","17 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Chronic recurrent multifocal osteomyelitis (CRMO) is a rare auto-inflammatory bone disease that primarily affects children and\u002For adolescents at a median age of 10 years. Until now, there is no consensus regarding the treatment of CRMO. Non-steroidal anti-inflammatory drugs (NSAIDs) are considered the first line of therapy with remission in approximately 30% of cases. If unsuccessful, several treatments are tried in addition to NSAIDs, including bisphosphonates and anti-TNFs.\n\nThe effectiveness of bisphosphonates (including zoledronate) has been reported in clinical cases and\u002For retrospective series. They are said to be particularly effective in multifocal forms, mandibular and\u002For vertebral involvement, but no controlled trials have been conducted. Bisphosphonates have even been proposed as first-line therapy in spinal involvement. The only prospective study, is a phase II trial currently underway in Denmark to study the efficacy of zoledronate (NCT02594878) versus placebo in SAPHO (acronym, standing for Synovitis - Acne - Pustulosis - Hyperostosis - Osteitis) patients considered to be a very similar form of CRMO occurring in adults.\n\nIn this context, this study proposes evaluate the efficacy of zoledronate compared to placebo in reducing pain at week 12 in children aged ≥4 and \\\u003C17 years with NSAID-resistant CRMO. Zoledronate will be administered in three escalating doses: 0.025 mg\u002Fkg at baseline (W0), 0.05 mg\u002Fkg at week 12 (W12), and 0.05 mg\u002Fkg at week 24 (W24). In addition to pain reduction, improvements in MRI findings will be observed, biological markers of inflammation, and quality of life in the zoledronate group. Although subjective, pain reduction remains the most widely used criterion in clinical practice to assess therapeutic efficacy. Zoledronate efficacy will therefore be assessed by the change in standardized pain score (0-10 scale) from baseline to week 12 as the primary endpoint, with additional pain assessments at weeks 4, 24, and 36 as secondary endpoints.",[28],"Osteomyelitis Chronic",[30],"Osteomyelitis","NOT_YET_RECRUITING","2026-06-21",{"date":34,"type":35},"2026-06-25","ACTUAL",{"date":37,"type":22},"2026-09-15",{"date":39,"type":22},"2029-12-31",{"name":41,"class":42},"Assistance Publique - Hôpitaux de Paris","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":43},"100562059","mirragen-diabetic-foot-ulcer-study-100562059","NCT06598241","Mirragen Diabetic Foot Ulcer Study","A Pilot, Post-market, Non-interventional, Prospective, Observational Study of Standard of Care of the Commercially Available Borate-base Bioactive Glass Fiber Matrix (BBGFM) in Treatment of Outpatient Diabetic Foot Ulcer With Chronic Osteomyelitis.","Inclusion Criteria:\n\n1. The subject has signed the informed consent form\n2. Subject is male or female aged between ≥ 18 or ≤ 80\n3. Subject scheduled to receive borate-based bioactive glass fiber matrix in treatment of index diabetic foot ulcer\n4. Index ulcer has not received an application of BBFGM previously\n5. Subjects with insurance coverage for BBGFM\n6. Subject has documented Type 1 or Type 2 diabetes with an HbA1c less than or equal to 12.0% within 90 days of enrollment.\n7. The subject is under the care of Physician for the management of Diabetes Mellitus\n8. Subject must have a wound present anatomically on the foot as defined by beginning below the malleoli of the ankle, dorsal surface, plantar surface, inter digital, heel, lateral or medial surface of the foot\n9. Subject index ulcers must be ≥ 0.5 cm2 and ≤ 8.0 cm2\n10. Index ulcer has been present for greater than 4 weeks prior to enrollment and less than 2-years, as of the date the subject receives the BBGFM\n11. The BBGFM will be applied in an outpatient setting\n12. Subject has an ulcer with a Wagner Grade 2 or 3 classification Wagner Grade 2: Deep ulcer extended to ligament, tendon, joint capsule, bone, or deep fascia without abscess or osteomyelitis Wagner Grade 3: Ulcers extend to the deep tissue and have either associated soft tissue abscess or osteomyelitis If Wagner Grade 3 Ulcer with chronic osteomyelitis, that can be debrided in an outpatient setting, in the opinion of the investigator\n\n    1. Exposed or palpable bone in the reference ulcer, that can be surgically excised in an outpatient clinic setting, using local anesthetic, at the screening or randomization visit\n    2. Less than a 1cm margin of peri-ulcer tissue of the reference ulcer, requiring surgical debridement, at the screening and randomization visit\n\n    Wagner Grade 3 subjects must have osteomyelitis diagnosed by:\n\n    X-ray: suggestive or positive for changes consistent with chronic osteomyelitis or Positive probe to bone (PTB) test or Strong clinical suspicion, in the opinion of the Investigator, in the presence of osteomyelitis in the index wound\n13. Subject does not require a surgical debridement in the operating room\n14. Subjects without active cellulitis at the index ulcer\n15. Subject or responsible caregiver is willing to comply with the dressing treatment and study visits\n16. Subject is willing to utilize the offloading device to offload wound\n17. If female, subjects must have been practicing adequate contraception (abstinence, barrier method, hormonal, or IUD). Must agree to using an accepted and effective form of birth control during the study.\n18. Subject has adequate circulation to the affected extremity, as demonstrated by at least ONE of the following tests within 60 days (about 2 months) prior to enrollment:\n\nA.Ankle-Brachial Index (ABI) of study leg(s) of ≥0.7 to ≤1.3 in conjunction with doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg Or B.Toe brachial Index (TBI) of ≥ 0.50 OR C.Great Toe Pressure 50mmHg OR D.Dorsum transcutaneous oxygen test (TcPO2) of study leg(s) of ≥40mmHg on the dorsum of the affected foot OR E.Palpable pulses\n\nExclusion Criteria:\n\n1. Subject is unwilling to sign informed consent\n2. Subjects who cannot obtain insurance coverage for BBFGM\n3. The BBFGM cannot be applied in an outpatient setting\n4. Index ulcer has previously received an application of BBFGM\n5. Subject has a major contralateral amputation of lower extremity, specifically transmetatarsal amputation or more proximal amputation\n6. Subject index ulcer has a known history of borate-base bioactive glass fiber matrix application\n7. Subject is pregnant or breast-feeding.\n8. Subject index ulcer associated with carcinoma.\n9. Subject has active Charcot Neuroarthropathy\n10. Subject requires extensive soft tissue and bone debridement in the operating room\n11. Subject has a life expectancy of less than six months as assessed by the investigator.\n12. Subject not in reasonable metabolic control in the judgment of the investigator\n13. Subject with a known history of poor compliance with medical treatments\n14. Subject currently undergoing cancer treatment\n15. Subject has been on oral steroid use of \\\u003C7.5 mg daily for greater than seven consecutive days in 30 days before screening\n16. Subject is taking parenteral corticosteroids or any cytotoxic agents for seven consecutive days in the period of 30 days before screening\n17. The subject has malignancy or a history of cancer, other than non-melanoma skin cancer, in five years before screening\n18. Subject has been diagnosed or had medical history with at least one of the following diseases: cancer, lupus, vasculitis, sickle cell, fibromyalgia, acquired immunodeficiency syndrome (AIDS) or HIV, uncontrolled rheumatoid arthritis, stage renal disease.\n19. Subject currently receiving radiation therapy or chemotherapy.\n20. Patient currently on dialysis or planning to start dialysis.\n21. Presence of any condition that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator\n22. Subject is unable to sustain off-loading as defined by the protocol\n23. Subject index ulcer that cannot be offload by an offloading device\n24. Subject index ulcer with acute osteomyelitis, as per no bony changes on x-ray and\u002For presence of acute cellulitis at the index ulcer\n25. Subject is anticipated to use Negative Pressure Wound Therapy (NPWT) on the index ulcer during the study\n26. Subjects who are permanently non-ambulatory (i.e. wheelchair bound)\n27. The subject is a woman of child-bearing potential who is unwilling to avoid pregnancy or use an appropriate form of birth control (adequate birth control methods are defined as: topical, oral, implantable, or injectable contraceptives; spermicide in conjunction with a barrier such as a condom or diaphragm; IUD; or surgical sterilization of partner)\n28. Subject has an allergy to primary or secondary dressing materials used in this trial\n29. In the opinion of the Investigator the subject is not appropriate for inclusion in the trial, e.g., undergoing surgical treatments listed in the protocol or subject currently has sepsis, i.e., life threatening organ dysfunction caused by a dysregulated host response to infection","18 Years","80 Years",{"count":54,"type":22},20,"OBSERVATIONAL","This study is being done to collect data from treatment of patients who have diabetes with non-healing foot wounds and are being treated with a resorbable and biocompatible borate-based bioactive glass fiber matrix. A borate-based bioactive glass fiber matrix is used to cover the ulcer for wound management. The primary objective of this study is to evaluate the safety and efficacy of the borate-based bioactive glass fiber matrix in the treatment of diabetic foot ulcers in a real-world setting. The secondary objective is to evaluate the clinical and financial benefits in terms of quality of healing, pain, and treatment cost.",[58,28],"Diabetic Foot Ulcer",[60],"Glass fiber matrix","RECRUITING","2026-06-02",{"date":64,"type":35},"2026-06-04",{"date":66,"type":35},"2024-09-20",{"date":68,"type":22},"2026-12",{"name":70,"class":42},"The University of Texas Health Science Center at San Antonio",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":52,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":83,"conditions":84,"keywords":85,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":98},"100424305","evaluation-of-the-efficiency-of-the-bone-substitute-cerament-g-locally-delivering-gentamicin-in-the-treatment-of-chronic-osteomyelitis-of-long-bones-100424305","NCT04805164","Evaluation of the Efficiency of the Bone Substitute Cerament-G Locally Delivering Gentamicin in the Treatment of Chronic Osteomyelitis of Long Bones","Evaluation of the Efficiency of the Bone Substitute Cerament-G Locally Delivering Gentamicin in the Treatment of Chronic Osteomyelitis of Long Bones: Randomized Multicentre Study in the CRIOAc Network - CONVICTION Study","CONVICTION","Inclusion Criteria:\n\n* Patient with suspected chronic osteomyelitis (stage III of the Cierny-Mader classification) of a long bone of the tibia, femur, humerus or forearm, at the diaphysis, metaphysis or epiphysis, defined as follows:\n\n  * Supposed inoculation \\> 3 months ;\n  * At least one of the following clinical signs at the suspected infected site:\n\n    * Spontaneous or supporting pain ;\n    * Presence of fistula; or history of fistula discharge\n    * Presence of serous or purulent flow;\n    * Presence of bone exposure;\n    * Local Inflammation;\n    * Fever in the absence of any other explanation.\n  * At least one of the following radiological signs at the suspected infected site:\n\n    * Bone reshaping with osteolysis or periosteal apposition;\n    * Presence of intramedullary abscess (if MRI performed);\n    * Presence of a fistulous pathway to the intramedullary (if MRI performed);\n    * Presence of bone sequestration visible on CT scan (if CT scan performed).\n* Patient in whom conventional surgical treatment of chronic osteomyelitis is possible, with decortication and corticotomy with endomedullary curettage (to eradicate bone sequestrums, reduce the inoculum, and identify the bacterium(s) involved) and secondary intramedullary residual cavity;\n* Patient in whom 3 months of systemic antibiotic therapy post-operatively are planned;\n* If osteosynthetic material is present in the infection site, this material should be considered preoperatively as completely removable during chronic osteomyelitis surgery;\n* Patient in whom a direct closure without tension is possible, or in whom a skin and soft-tissue\u002Fmuscle flap can be performed within 15 days after the initial surgery;\n* Male or female patient between 18 and 80 years of age;\n* Patient who has given written informed consent to participate in the study;\n* Geographically stable patient;\n* Patient able to comply with follow-up visits, protocol schedule and therapeutic treatment, according to investigator's judgement;\n* Affiliated patient or beneficiary of a social security system\n\nExclusion Criteria:\n\n* Acute hematogenic osteomyelitis (Cierny-Mader stage I) ;\n* Cortical osteitis (Cierny-Mader stage II);\n* Septic pseudoarthrosis (Cierny-Mader stage IV);\n* Patient requiring an estimated skin and soft-tissue\u002Fmuscle flap that cannot be done within 15 days after surgery for the treatment of chronic osteomyelitis;\n* Woman who is pregnant, nursing or who is considering becoming pregnant during the study period;\n* Patient participating in another interventional study that could interfere with it;\n* Patient known to have hypersensitivity to aminoglycosides (especially gentamicin), sulfites (including calcium sulfate) or calcium hydroxyapatite;\n* Contraindication to the use of Cerament-G: severe myasthenia (class IV or higher according to the MGFA classification), , severe renal insufficiency (creatinine clearance \\\u003C30 mL\u002Fmin according to the Cockcroft-Gault formula, or GFR \\\u003C 30 ml\u002Fmin\u002F1.73² according to the CKD-EPI or MDRDs equation or, dialysis patient), pre-existing disorders of calcium metabolism (total plasma calcium (or total corrected plasma calcium according to albuminemia) outside normal laboratory values);\n* Patient with endocrine or metabolic disorders known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, hyperthyroidism, parathyroid disorder, Ehler-Danlos syndrome, osteogenesis imperfecta);\n* Patient with one or more untreated malignant cancers (including Marjolin's ulcer), or undergoing radiotherapy or chemotherapy;\n* Adult patient protected by law, under guardianship or trusteeship.",{"count":80,"type":22},220,[82],"NA","Chronic osteomyelitis is a serious osteoarticular infection that most often occurs in the long bones (tibia, femur, humerus), responsible for significant morbidity with risk of fracture and amputation. It is due to the presence of bacteria in the bone marrow, sometimes responsible for an intraosseous abscess.\n\nChronic osteomyelitis can have a hematogenous or more often exogenous origin, after trauma or surgery. The bacteria involved have the ability to modify their metabolism and involve persistence mechanisms (such as biofilm) making them difficult to eradicate. The treatment of chronic osteomyelitis requires surgery, i.e. corticotomy, which means opening of the bone cortex to perform an endomedullary curettage to identify the bacteria, remove any sequestration (bone fragments to which the bacteria adhere as biofilm) and reduce the bacterial inoculum. At the same time, or at a second stage, a skin and soft tissue\u002Fmuscle flap may be required, especially in patients with long-standing disease with embrittlement and adhesion of the skin and soft tissue to the underlying bone.\n\nPost-operatively, the patient receives a probabilistic systemic antibiotic therapy and then a systemic antibiotic therapy targeted on the identified germ, for a period of 3 months. The effectiveness of these antibiotics is based on their ability to penetrate bone tissue. Despite the progress made in both antibiotics and surgical treatments, the probability of failure (recurrence of infection) is around 20%, and has unfortunately remained stable for more than 20 years.\n\nCerament-G (BONESUPPORT AB Laboratory, Sweden), a synthetic bone substitute composed of hydroxyapatite, calcium sulphate, and gentamicin, fills the \"dead space\" formed during surgery, prevents infection of this blood-filled cavity, and promotes bone regeneration within this space (limiting the risk of fracture in the medium and long term). Cerament-G also delivers locally very high doses of gentamicin (concentration of 17.5 mg\u002FmL in the device) for several weeks. Gentamicine is a broad-spectrum bactericidal antibiotic effective against the vast majority of bacteria involved in osteoarticular infections. It provides effective local antibiotic therapy through wide exposure and prolonged concentrations during several weeks.\n\nTo date, there is no other bone substitute with antibiotics available in France. Two prospective studies have shown that Cerament-G reduces the number of infectious recurrences (about 5%).\n\nThis innovation is available in France but at a high price (between 2,500 and 4,000 euros) and is not currently reimbursed. However, the use of this product would make it possible to improve the health and quality of life of patients while avoiding certain consumption of resources.",[28],[86,87,88],"Bone infection","chronic osteomyelitis","bone substitute","2024-07-11",{"date":91,"type":35},"2024-07-12",{"date":93,"type":35},"2021-10-14",{"date":95,"type":22},"2027-11-14",{"name":97,"class":42},"Hospices Civils de Lyon",15]