Fort Walton Beach

Researchers are conducting a multi-center, randomized controlled clinical trial to compare the effectiveness of Porcine Placental Extracellular Matrix PPECM combined with standard wound care versus standard wound care alone in treating hard-to-heal diabetic foot ulcers. This study focuses on adults with diabetic ulcers that have shown delayed healing and aims to improve closure rates over a 12-week period. Participants are divided into two groups. One group receives standard wound care, which includes wound cleansing with sterile solutions, wound bed debridement as needed, appropriate primary and secondary dressings to maintain a moist environment, off-loading devices to reduce pressure on the wound, and systemic antibiotics when necessary. The other group receives the same standard care plus weekly applications of PPECM for up to 12 weeks, applied after cleansing and debridement but before the primary dressing. During the study, participants will undergo regular wound assessments to monitor healing progress, including measurement of wound closure at 12 weeks as the primary outcome. They will be followed with weekly visits for wound care and PPECM application if assigned to that group. Researchers will also evaluate safety and adherence throughout the study. The total participation time spans at least 12 weeks, with ongoing monitoring to determine the effectiveness of the combined treatment in promoting diabetic foot ulcer healing.

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.