Ashtabula

Researchers are evaluating the use of Derm-Maxx, an acellular human dermis graft, as an additional treatment for patients with diabetic foot ulcers that have not healed with standard care alone. This multicenter randomized open-label trial focuses on patients with Wagner grade 1 and 2 diabetic foot ulcers. The study aims to assess healing rates and wound closure over a 12-week treatment period, with at least half of the participants being 65 years or older. Participants will undergo a 2-week run-in period before being randomly assigned to receive either Derm-Maxx plus standard of care or standard of care alone. During the 12-week treatment phase, patients will have weekly visits to monitor ulcer healing, with additional dressing changes recorded as needed. Derm-Maxx is applied to ulcers that have been properly prepared and offloaded using a specific device. The study also evaluates pain and safety alongside healing outcomes. Throughout the study, participants will be closely monitored with assessments of ulcer size, wound closure, and circulation to the affected foot. Researchers will collect data through physical exams, wound measurements, and adherence to offloading protocols. Safety and pain levels will be tracked to ensure participant well-being. The total duration of participation includes screening, run-in, treatment, and follow-up visits over at least 12 weeks.

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.

This research evaluates the risk of nerve damage after using two types of local anesthesia for the Inferior Alveolar Nerve Block (IANB): 4% articaine and 2% lidocaine. It is a phase 1 randomized controlled clinical trial focused on patients needing IANB, aiming to compare the safety of these anesthetics in relation to nerve injury. Participants are healthy adults between 18 and 55 years old. Participants will be randomly assigned to receive either 4% articaine with epinephrine or 2% lidocaine with epinephrine for the nerve block. The type of anesthesia used will be hidden from the operator, investigators, and assessors to ensure unbiased results. This study specifically monitors nerve function following the procedure. After receiving the anesthesia, patients will be observed for signs of nerve problems such as paresthesia for 3 months. Researchers will use electromyography to assess nerve activity during this period. The study focuses on tracking any nerve damage and maintaining safety throughout the follow-up.

Researchers are evaluating a stepped care approach called STARRS-PC (Stepped Approach to Reducing Risk of Suicide in Primary Care) to reduce suicide risk among youth aged 12 to 17 years who receive pediatric primary care. Suicide is a leading cause of death in this age group, and many at-risk youth are not identified or treated. This five-year study tests the effectiveness of STARRS-PC compared to usual care (treatment as usual, TAU) across 14 pediatric primary care clinics. The study also examines factors affecting the implementation and sustainability of this suicide prevention approach using the Practical, Robust Implementation, and Sustainability Model (PRISM).