Sunnyvale

The trial investigates the use of Amnio-Maxx as an additional treatment for patients with diabetic foot ulcers (DFUs) that have not responded to standard care alone. It focuses on patients with Wagner grade 1 and 2 chronic ulcers, mostly including individuals aged 65 years or older. The study aims to assess how well Amnio-Maxx helps heal these ulcers compared to standard care, measuring wound closure and reduction in ulcer size over 12 weeks. Participants will first undergo a 2-week run-in period before being randomly assigned to receive either Amnio-Maxx combined with standard care or standard care alone. The Amnio-Maxx patch is processed using special aseptic techniques and dehydrated with saline. Patients will be monitored weekly for 12 weeks, with additional visits if needed for dressing changes. The study collects data on wound healing progress, pain levels, and safety. Throughout the study, participants will attend weekly visits for assessments including wound size measurements, safety checks, and pain evaluations. Healing will be verified independently at 12 weeks. Participants must follow offloading protocols for the ulcer site and provide informed consent. The trial tracks healing outcomes and monitors for adverse events, aiming to understand the effectiveness and safety of Amnio-Maxx in managing diabetic foot ulcers.

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.