Fort Walton Beach

Researchers are evaluating surgical and minimally invasive treatments for lumbar spinal stenosis (LSS) by comparing Medicare patients who received the MILD procedure against those who had interspinous process decompression (IPD). The study focuses on outcomes such as the rate of harms related to the initial procedure and the frequency of additional surgical or minimally invasive interventions within 24 months after treatment. Enrollment includes patients treated from January 1, 2017, onward, with continuation until the sponsor decides to stop. The MILD procedure involves percutaneous image-guided lumbar decompression, performed under fluoroscopy through a dorsal approach to partially remove tissue and bone at the affected spinal level. The control group receives the IPD procedure for LSS. Both groups are monitored for a 24-month period post-index procedure using Medicare claims data to track reoperations and any harms. Participants contribute data through Medicare claims without needing prior enrollment or consent, as the study is exempt from IRB oversight. Researchers collect and analyze information on procedure-related harms and subsequent interventions over two years. This approach allows evaluation of long-term safety and effectiveness outcomes for patients treated with either MILD or IPD.

Researchers are evaluating the safety and effectiveness of adding a human placental allograft called BioREtainAmnion Chorion (BR-AC) to standard care for treating non-healing, non-infected venous leg ulcers (VLUs) with confirmed venous reflux and adequate arterial blood flow. The study includes patients with VLUs between 2 cm and 20 cm in area that have lasted between 4 weeks and 52 weeks. It aims to find out if weekly applications of BR-AC plus standard care lead to more wounds fully healing within 12 weeks compared to standard care alone. Participants first undergo a two-week run-in period with standardized care including compression therapy to exclude those whose wounds are likely to heal quickly without BR-AC. Eligible subjects are then randomly assigned to receive either standard care alone or standard care plus weekly BR-AC applications. Standard care involves sharp wound cleaning, moist wound dressings, and compression with the UrgoK2dual compression system. If wounds do not fully heal after 12 weeks on standard care alone, participants can crossover to receive BR-AC treatment for an additional 12 weeks. Throughout the study, weekly visits monitor wound healing progress using an electronic device to measure wound size accurately. Participants who achieve complete wound closure enter a four-week follow-up with visits every two weeks to assess the durability of healing. The main goal is to determine whether BR-AC combined with standard care improves the chance of full wound closure within 12 weeks compared to standard care by itself.