Nevers

Diabetic Foot Ulcer (DFU) is a serious complication seen in people with diabetes, often leading to non-traumatic lower-limb amputation and linked to cognitive decline and lower quality of life. Despite advances in medical care, patients with DFU face a higher risk of early death, which may be due to factors beyond cardiovascular disease, such as inflammation, infections, and cancers. This research aims to be the first prospective, observational, multi-center cohort study in France to explore the 5-year mortality rate and its causes among patients with DFU, along with identifying important factors that predict outcomes. The study will include adults with diabetes who have a foot ulcer or an open lower-limb amputation wound caused by diabetic complications. Participants will be enrolled over a 3-year period starting in 2020 and followed for up to 5 years or until death. This observational study will use data from multiple centers across France and will also evaluate changes in health-related quality of life and the economic impact of DFU on the French healthcare system by using national claims databases. During the study, participants will be monitored for their health status, including the risk of diabetic foot ulcer recurrence or worsening, and causes of death over five years. Researchers will collect data on quality of life and healthcare costs to better understand the burden of DFU. The primary outcome measured will be the DFU risk score assessed 5 years after inclusion, providing insights into prognosis and factors influencing survival and health outcomes in this population.

Colorectal cancer mainly affects elderly patients, with over half of new cases in France occurring in those aged 70 or older. Adjuvant chemotherapy has shown benefits in disease-free and overall survival after stage III colon cancer surgery, but its use in elderly patients remains limited. This phase III randomized study explores whether adjuvant chemotherapy improves disease-free survival in elderly patients and which chemotherapy regimen is most effective, addressing concerns about benefits for both unfit and fit elderly patients. Participants will be divided into two groups based on a multidisciplinary evaluation including a geriatrician. One group will receive fluoropyrimidine-based chemotherapy (LV5FU2 or capecitabine), and the other will receive oxaliplatin-based chemotherapy (FOLFOX4 or XELOX). Some patients may be assigned to observation only. Treatments will begin within 12 weeks after surgery. The study also evaluates specific biological markers common in elderly tumors, such as mismatch repair deficiency. During the study, participants will undergo assessments including geriatric questionnaires and medical monitoring. Researchers will track disease-free survival over three years following the last patient's enrollment. Safety and treatment effects will be monitored, with exclusion of patients expected to live less than four years or those unable to comply with follow-up. The study aims to better understand chemotherapy benefits in an elderly population after colon cancer surgery.