Leesville

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 the healing of diabetic foot ulcers by comparing the usual standard of care (SOC) treatment alone with SOC combined with Omeza4 Complete Matrix (OCM). The study seeks to determine if adding OCM helps increase the chances of complete wound closure within 12 weeks. This trial is open-label and conducted at multiple medical centers, involving adult patients with diabetic foot ulcers that meet specific healing and size criteria. Participants will be randomly assigned to receive either SOC alone or SOC plus OCM. SOC includes surgical sharp debridement, offloading using methods like total contact casting or fixed ankle-walker, and maintaining proper moisture balance. Patients in the SOC group who do not achieve complete wound closure by about 84 days may switch to the SOC plus OCM group for up to 12 weekly treatments while continuing follow-up visits. This crossover design allows additional assessment of OCM's effects after initial treatment. During the study, participants will undergo regular treatment visits and follow-ups, with wound healing closely monitored. Researchers will measure the primary outcome of complete wound closure within 1 to 12 weeks. Assessments include wound measurements, infection control, circulation checks, and adherence to offloading therapy. Safety and treatment effectiveness data will be collected to support future insurance reimbursement decisions and provide detailed information on OCM's role in diabetic foot ulcer care.

Researchers are conducting the Military Health and Nutrition Examination Study (MHANES), a Department of Defense funded project led by Pennington Biomedical Research Center and the US Army Research Institute of Environmental Medicine. This cross-sectional study involves a large and diverse group of 600 Army Service Members, aiming to gather comprehensive data on dietary intake, nutritional status, cardiovascular health, body composition, metabolic biomarkers, injury prevalence, mental wellbeing, gut microbiome composition, and physical performance. The study is modeled after the National Health and Nutrition Examination Survey (NHANES) but tailored specifically for the Army population to better understand health and nutrition relationships in active-duty Soldiers. The study collects detailed information through interviews and assessments, including two 24-hour dietary recalls using the ASA24® system, conducted at the first visit and again 3 to 10 days later. Participants will provide biological samples that may be stored for future research and data will be linked to the Soldier Performance, Health, and Readiness (SPHERE) database. This approach helps capture a broad picture of health status and nutrition among Soldiers. Participants will undergo evaluations of cardiovascular health, body composition, laboratory tests for biomarkers, and physical performance measurements. Researchers will assess mental wellbeing and gut microbiome composition as well. Throughout the study, data on health status and injury prevalence will be collected. The study aims to provide valuable insights into disease prevalence and health factors affecting Soldiers, with a focus on conditions like hypertension, type 2 diabetes, dyslipidemias, and cardiovascular diseases.

Researchers are evaluating the safety and effectiveness of the NeoThelium FT Amnion Skin Graft in treating diabetic foot ulcers. This prospective case series study involves participants with Type I or Type II diabetes who have diabetic foot ulcers of specific grades and sizes. The study is open-label, meaning both researchers and participants know the treatment being used. It aims to collect information useful for treatment evaluation and insurance reimbursement decisions. Participants will receive standard care plus weekly applications of NeoThelium FT, a dehydrated wound covering made from donated human placental tissue consisting of amnion and chorion layers. The treatment will continue according to a set schedule, with follow-ups as planned. This study is conducted across multiple medical centers and focuses on ulcers treated with specific offloading therapies prior to treatment. During the study, participants will be monitored for complete wound closure within 1 to 12 weeks. Researchers will assess the wound healing progress and ensure safety throughout the treatment period. Participants must meet specific health criteria and follow the study protocol, including regular visits and wound evaluations to track treatment outcomes.