Clinical trials

The number of people living with diabetes has quadrupled worldwide since 1990, and more than 4.5 million people in France have diabetes. This chronic disease is a major cause of blindness, kidney failure, myocardial infarction, stroke, and lower-limb amputation. In France, in 2013, the incidence rates of hospitalizations for lower-limb amputation and diabetic foot ulcer among people with diabetes were 252 per 100,000 and 668 per 100,000 individuals with diabetes, respectively. The management of diabetic foot disease requires a multidisciplinary approach involving general practitioners, diabetologists, dietitians, podiatrists, physiotherapists, and nurses. Nurses working in diabetic foot clinics, wound care centers, and community settings play a key role throughout the continuum of care for people with diabetes. Their responsibilities include prevention, patient education, clinical monitoring, and wound management. When one or more warning signs are identified, nurses promptly alert the physician to ensure early management of infection and timely referral to the appropriate healthcare professional(s). One of the major factors contributing to impaired wound healing and ultimately leading to amputation in people with diabetes is arterial insufficiency. This condition is most commonly caused by peripheral artery disease (PAD), which is characterized by progressive atherosclerotic obstruction of the arteries supplying the lower limbs and represents a major cardiovascular disease. In patients with diabetes, PAD differs from atherosclerotic disease in non-diabetic individuals not only because of its higher prevalence but also because of its earlier onset, its frequently asymptomatic course, its predominantly distal distribution involving the infrapopliteal and even below-the-ankle arteries, and its greater severity. The reference standard for diagnosing arterial insufficiency in patients with diabetes relies on quantitative microcirculatory assessment performed by vascular specialists. These investigations are based on arterial Doppler ultrasound and combine ankle and toe pressure measurements. The ankle-brachial index (ABI), the standard diagnostic test for PAD in non-diabetic patients, has limited reliability in individuals with diabetes because medial arterial calcification frequently renders the arteries incompressible. In contrast, toe pressure measurements can be performed in virtually all patients with diabetes who have intact toes. In selected cases, transcutaneous oxygen pressure (TcPO₂) measurement may also provide valuable additional information. The availability of these investigations depends on access to vascular specialists, as a comprehensive vascular assessment may take up to two hours and varies according to local clinical practice and available resources. Portable handheld vascular Doppler devices equipped with an 8-MHz probe are now available at an affordable cost and can be readily used in diabetic foot clinics, wound care centers, and community-based practices. We hypothesize that this medical device, which assesses the overall hemodynamic status of the lower limb, could serve as a first-line screening tool for patients with diabetes presenting with a foot wound. This rapid assessment could facilitate early identification of patients requiring further vascular investigations by a vascular specialist when no arterial blood flow is detected.

Persistent glomerular hyperfiltration is a characteristic feature of the early stages of kidney disease and represents a factor in the progression of chronic kidney disease (CKD). In this context, the benefit of low-protein diets (less than 0.8g/kg/day) has been demonstrated in slowing the progression of CKD, although the underlying pathophysiological mechanisms remain unclear. Some studies suggest that the effects of protein on renal hemodynamics are primarily linked to the quality of the protein, particularly the amount of AGEs (Advanced Glycation End Products) consumed. Recently, edible seaweeds have gained popularity in Western countries due to their anti-inflammatory, anti-diabetic, and antihypertensive properties. These seaweeds are also associated with the above-average longevity of certain Asian populations who consume them daily. Wakame seaweed (Undaria pinnatifida), which is locally harvested along the French Atlantic coast, has shown promising biological properties, notably antihypertensive and anti-diabetic effects. It has also been recently demonstrated that fucoxanthin, a compound found in high concentrations in wakame, possesses strong anti-AGE activity. Dietary modifications are essential for nephroprotection, but they are often difficult to implement. This highlights the need to develop approaches that are both acceptable on a daily basis and sustainable in the long term for patients. A Michelin-starred chef, known for regularly incorporating seaweed into his cuisine, is a sponsor of the project and has validated a set of adapted recipes that will be offered to participants to accompany the daily wakame supplementation. The investigator's hypothesis is that a daily dose (5 grams of French wakame, dehydrated at low temperature and in flake form), equivalent to the average daily intake in Japan, could reduce circulating AGE levels in patients with stage III CKD. This would provide an additional protective effect when combined with the standard low-protein diet, helping to slow the progression of CKD over the long term.

Abdominal aortic aneurysm, a condition characterised by an increase in the diameter of the aorta, can be treated either surgically or endovascularly. In the latter, an endoprosthesis consisting of a metal spring covered with an impermeable fabric is inserted through an artery and deployed inside the aorta. This new method appears to be less invasive than surgery, but its long-term results are not yet fully understood. As a result, patients who have undergone this treatment are monitored by their surgeon to ensure that there is no endoleak. Several research teams have proposed analysing medical images to predict this risk of endoleak. Doctors are now trying to use artificial intelligence to automate the analysis of these images.

Giant cell arteritis is a vasculitis, i.e. inflammation of the artery walls, which generally affects people over the age of 50. Diagnosis can be long and difficult, as the clinical signs are not specific (headache, pain in the jaw, scalp, shoulders and/or pelvis, abdominal pain, weight loss, etc.), but it must be made quickly, given the risk of complications. The reference method for diagnosis was initially based on clinical suspicion and analysis of a "piece of temporal artery" (biopsy) performed in the operating theatre under local anaesthetic. Since the mid-1990s, improvements in ultrasound techniques have made it possible to identify a sign, known as a halo, on the temporal arteries that is typical of patients with Giant Cell Arteritis. A prospective multicenter study published in 2024 demonstrated that, in patients with a clinical suspicion of Giant Cell Arteritis, if a halo was found on both temporal arteries by ultrasound, there was no need for a biopsy. This study is at the origin of a change in practices in the diagnosis and care of patients suffering from this disabling disease. To facilitate early diagnosis, a fast-track pathway has been set up. The aim is to make a rapid diagnosis, thereby reducing the risk of after-effects, shortening the length of hospital stays, considering outpatient treatment and limiting the number of biopsies. The investigators propose to evaluate the performance of this fast-track pathway.

Age is a major risk factor for the development of cognitive disorders and neurodegenerative pathologies. Cognitive disorders during the phases of bipolar disease are known to exist, and alterations increase significantly after the age of 65. Drug treatments seem to have only a limited effect. A cognitive stimulation program has proven his benefit to patients over 65 with neurodegenerative diseases (Israel, 2004). We propose to evaluate this cognitive stimulation program that we have adapted to bipolar disease.