Oradell

This trial investigates the use of genex with gentamicin genex G, an antibiotic-loaded bone void filler, as part of the surgical treatment for osteomyelitis in the extremities. It is a multi-center, single-arm pivotal device study focusing on patients diagnosed with osteomyelitis classified by the Cierny-Mader system grades I-IV. The goal is to evaluate the safety and effectiveness of genex G in supporting bone healing and treating the infection. Participants will undergo surgical debridement followed by implantation of genex with gentamicin into the bone void as part of their treatment. They will also receive antibiotics according to clinical needs determined by their treatment site. The study involves a single treatment group where all participants receive genex G during surgery, and they will be monitored for 24 months after treatment to assess outcomes. During the study, participants will have regular follow-up visits to monitor infection resolution, bone healing, and any adverse events. Assessments include clinical evaluations, radiographic imaging, and quality of life questionnaires over a 24-month period. Researchers will measure the need for additional antibiotics or surgery, recurrence of infection signs, bone healing progress, and safety related to the device. The total participation time extends up to 24 months after surgery.

Researchers are evaluating ELU42, a topical small molecule combining a tankyrase inhibitor with a special hyaluronic acid, to study its safety and early effects on chronic diabetic foot ulcers. This Phase IIIA open-label study focuses on adults with Wagner grade 1-2 diabetic foot ulcers lasting between 4 and 52 weeks. The study aims to assess how ELU42 affects wound healing and monitors safety through various health measures. Participants will first receive standard wound care for two weeks, including offloading, dressings, and cleaning. Then, ELU42 topical spray will be applied by trained staff to the ulcer three times a week for six weeks, with up to 18 treatments possible. If the wound heals but later reopens, participants may undergo another six-week treatment course. The study includes weekly visits during treatment and follow-ups for up to six weeks, with additional visits if the wound closes to observe healing over three months. During the study, participants will undergo safety evaluations such as blood tests, heart monitoring, and nutritional assessments. Researchers will measure wound healing by tracking the reduction in ulcer area at weeks 4 and 6 using both manual and automated methods. Secondary assessments include complete wound closure, wound hydration, patient-reported outcomes, and drug level monitoring in some participants. The total participation time includes treatment and follow-up periods up to several months.

Researchers are comparing the rates of surgical and minimally invasive interventions, as well as any harms, in Medicare beneficiaries treated with the MILD procedure versus those treated with interspinous process decompression IPD for lumbar spinal stenosis with neurogenic claudication. This observational study uses Medicare claims data to follow patients for 24 months after their initial procedure starting from January 1, 2017. The purpose is to evaluate outcomes between these two types of procedures without requiring prior patient enrollment or consent. The study includes two groups patients who received MILD, which is a percutaneous image-guided lumbar decompression performed under fluoroscopic guidance through a dorsal approach to the spine, and patients who received IPD, a different device-based decompression procedure. Data on reoperations and complications will be collected for both groups over a 24-month follow-up period using Medicare claims. Enrollment continues until the sponsor decides to stop. Participants involvement is passive as the study uses existing Medicare claims data. Researchers will monitor rates of harms related to the initial procedure and subsequent surgical or minimally invasive interventions over two years. No direct patient visits or interventions are conducted, and the study is exempt from institutional review board oversight. The total study duration extends to December 2026, covering cases treated since early 2017.