Minden

This research aims to evaluate the effectiveness of a multi-level, evidence-based weight loss program called LA-CEAL CONNECT for adults living with obesity in low-income and underserved communities in Louisiana. The study seeks to determine if LA-CEAL CONNECT leads to greater weight loss at 6 months compared to enhanced usual care, and whether weight loss is sustained at 12 months. The trial also examines improvements in waist size, diet quality, physical activity, quality of life, and blood pressure, while assessing the feasibility of implementing the program in these communities. Participants in both study groups receive health literacy-tailored educational materials and resources for weight loss and attend clinic visits at baseline, 6 months, and 12 months for clinical and survey assessments. Those in the LA-CEAL CONNECT intervention group additionally receive virtual health coaching from trained community health workers over 6 months, use digital tools like cellular-connected scales and wrist fitness trackers for daily self-monitoring of weight and activity, and attend group meetings to enhance use of community health and wellness resources identified through community asset mapping. The program also includes provider training and an obesity management toolkit for primary care providers at participating clinics. Throughout the study, participants are monitored through clinical visits collecting physical measurements and surveys at three timepoints over one year. Coaches remotely track weight and physical activity data to provide personalized support. The primary outcome is the difference in percentage weight change between groups at 6 months. The study also evaluates other health and behavioral measures, program feasibility, and sustainability over 12 months.

Researchers are evaluating the effectiveness of NeoThelium FT combined with standard care compared to standard care alone in treating diabetic foot ulcers. This open-label, randomized controlled crossover trial involves patients with chronic diabetic foot ulcers and aims to assess wound healing within 12 weeks. The study is conducted across multiple medical centers and includes a crossover option for patients not healed after initial treatment with standard care alone. Participants are randomly assigned to either standard care, which includes wound cleansing, debridement, moisture-balancing dressings, and offloading, or to standard care plus weekly applications of NeoThelium FT, a dual-layer membrane derived from donated human placental tissue. Those in the standard care group who do not achieve complete wound closure by about 84 days may cross over to receive NeoThelium FT weekly for up to 12 visits while continuing scheduled follow-up. Before randomization, all participants undergo a two-week screening phase. During the study, researchers will monitor wound closure rates, time to closure, wound area reduction, and pain. Assessments include measuring wound healing progress and ensuring ulcers remain free of infection. The study supports data collection for insurance reimbursement decisions and includes safety monitoring throughout the treatment and follow-up periods.

Researchers are evaluating the effectiveness of NeoThelium FT combined with standard care compared to standard care alone in treating chronic open wounds. This randomized controlled crossover trial takes place at multiple medical centers and is open label, meaning both researchers and participants know the treatment being given. The study aims to support insurance decisions by gathering data on wound healing and pain reduction, focusing on wounds that have not sufficiently healed within 14 days prior to screening. Participants will be randomly assigned to either receive standard care alone—which includes wound cleansing, sharp debridement, moisture-balancing dressings, and offloading therapy—or standard care plus weekly applications of NeoThelium FT, a dual-layer wound covering made from human placental tissue. After about 84 days, those in the standard care group whose wounds have not fully closed may switch to the NeoThelium FT treatment for up to 12 weekly applications, continuing follow-up as scheduled. Participants will undergo a two-week screening before randomization. Throughout the study, researchers will monitor wound closure rates over 12 weeks, wound size reduction, and pain levels. Assessments will include wound measurements and evaluations for infection or complications. Safety and adherence to treatment protocols will be closely observed during the study period.

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.