Timing of Revascularization in Patients With Diabetic Foot Ulcer and Non-critical Peripheral Artery...
Diabetic Foot UlcerThis study investigates whether, compared to standard treatment, immediate restoration of blood flow (revascularization) can reduce complications and improve diabetic foot ulcer healing.
Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis...
ColitisUlcerativeFlare-up of ulcerative colitis (UC) is characterized by the inflammation of colon mucosa that requires the use of immunosuppressive therapies. In previous studies, the active role of cytomegalovirus (CMV) has been demonstrated, with a correlation between the cytomegalovirus DNA ((deoxyribonucleic acid) load in the inflamed tissue and the resistance to successive lines of immunosuppressive therapy (Roblin et al., Am J Gastroenterol 2011). The main aim of this monocentric prospective study is to evaluate the DNA viral load by qPCR (Polymerase Chain Reaction) of 3 herpesviruses (Epstein-Barr virus, herpes virus 6 and herpes simplex) together with that of CMV in colonic mucosa depending of the local inflammation (endoscopically normal region, inflamed mucosa or ulcer) in patients suffering of moderate to severe UC flare-up (Mayo score >6 with endoscopic score higher or equal than 2). The viral load will also be correlated to the Mayo endoscopic score and the response to immunosuppressive drugs (steroid and anti-TNF (Tumor Necrosis Factor) monoclonal antibodies).
Pressure and Diabetic Foot
Diabetes and Risk of Diabetic Foot UlcerDiabetic foot ulcer (DFU) is a worldwide burden in the management of patients with diabetes. Peripheral neuropathy has a key role in the physiopathology of DFU. Others factors as skin vulnerability to plantar pressure, glycation of skin protein, articular rigidity, vascular component and abnormal foot plantar pressure are also important to take into account. The aim of the study is to assess prospectively different factors involved in DFU pathogenesis notably the neurovascular response to non noxious pressure.
Crossing the Divide: Piloting Integrated Care to Reduce Amputations Among Rural Patients With Diabetic...
Diabetic FootDiabetic Ulcer of Left Foot2 moreThis project directly addresses the escalating national rate of major (above-ankle) amputations due to diabetic foot ulcers; it focuses on rural patients, who face 37% higher odds of major amputation compared to their urban counterparts. The project pilots the first integrated care model adapted to rural settings, an approach that has reduced major amputations in urban settings by approximately 40%. Pilot data will be used to improve recruitment and retention strategies and provide preliminary evidence of efficacy needed to conduct a robust, statewide efficacy trial.
A Study to Evaluate Efficacy and Safety of MK-7240 in Participants With Moderately to Severely Active...
Ulcerative ColitisThe purpose of this protocol is to evaluate the efficacy and safety of MK-7240 in participants with moderately to severely active ulcerative colitis. Study 1's primary hypotheses are that at least 1 MK-7240 dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12, and that at least 1 MK-7240 dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at week 52. Study 2's primary hypothesis is that at least 1 MK-7240 dose level is superior to Placebo in the proportion of participants achieving clinical remission per Modified Mayo Score at Week 12.
Prebiotics in Reducing Inflammation and Clinical Endpoints in Ulcerative Colitis (PRInCE-UC)
Ulcerative ColitisThe community of microbes living in the gut is called the 'gut microbiome'. Changing this could be an exciting new way of treating people living with ulcerative colitis (UC). UC is a type of inflammatory bowel disease. It affects 4 in every 1000 people in the UK. UC causes severe episodes of inflammation leading to bloody diarrhoea. The gut microbes of people living with UC are different to those in healthy people. This may be part of the reason people with UC have a more inflamed gut. Prebiotics are types of fibre in the diet which help feed the positive microbes in the colon. Eating them can change the make-up and activity of the bugs which live in our gut in a good way. The goal of this clinical trial is to test the effect of a type of prebiotic called a human milk oligosaccharide (HMO) on the symptoms of patients with UC. The main questions it aims to answer are: Can a prebiotic improve symptoms for patients living with UC? Can a prebiotic improve the gut microbiota of people living with UC, and improve markers of inflammation, metabolism and immune function? Patients will take a sachet containing either the prebiotic or a placebo for four weeks, then swap to the other sachet. The trial will be double-blind and randomised. This 'crossover' design means patients act as their own control, which is important in gut microbiology studies. The prebiotic's effect on patient symptoms, metabolism and immune system will be measured. The investigators plan to recruit 44 participants over 18 months. Their urine, blood and stool will be tested. This project will be the first 'bench to bedside' study into the use of prebiotics in IBD. The treatment in this project is rooted in gut model studies. Different prebiotics were tested in the lab to determine which was the best to use for the trial. This 'lab first' approach is a first of its kind.
Health Benefits of Tart Cherry in Ulcerative Colitis
Ulcerative ColitisUlcerative Colitis (UC) is a long-term inflammatory condition of the digestive tract. People with UC often have unpredictable and debilitating symptoms, including abdominal pain, diarrhoea and fatigue. In addition, they require long-term treatment with frequent negative effects, the need of surgery and hospitalisations. Therefore, people with UC report a lower health-related quality of life (HRQOL) compared with healthy individuals. The most common medication for inflammatory bowel disease is a strong immunosuppressant which has previously (in 2017) been found to be the most expensive medication prescribed at hospitals in the NHS. Unfortunately, biologics has a lot of negative side effects and thus reducing the need of them in patients can benefit both the NHS as a whole by reducing the cost and improving the quality of life of patients by reducing the unwanted side effects of the biologics. Supplementation of Montmorency tart cherry juice might be a simple, safe, and low-cost intervention for improving symptoms in patients with UC. This is because it has the potential to naturally reduce inflammation in the digestive system and thus improve symptoms. Research in animal models has shown a potential for improvement in physiological responses with similar supplements including blueberries, black raspberries and even Montmorency tart cherries, with only one study in human participants exploring bilberry supplementation. However, despite anthocyanins concentrations from Montmorency tart cherries being superior to other berries, dietary interventions using tart cherry supplementation for UC have not received any attention in human participants. The primary purpose of the proposed investigation is to undertake a placebo randomized control trial examining the ability of a Montmorency tart cherry juice supplement to provide symptom relief and health related wellbeing outcomes in those with mild to moderately active UC and to understand the biological mechanisms behind any changes in symptoms.
Prediction of Dietary Intervention Efficacy in Mild Ulcerative Colitis Patients Based on Fecal Microbiome...
Ulcerative ColitisA double-blind randomized placebo-controlled parallel trial with two intervention arms and two placebo arms and a period of eight intervention weeks to validate the prediction that prebiotics could induce a higher response in mild UC patients with certain fecal microbiome signatures.
Phase 2 Study of CU104 in Moderate-Severe Ulcerative Colitis
Ulcerative ColitisThe study is designed to investigate efficacy and safety of CU104 in patients with moderate to severe ulcerative colitis.
Sterile Wound Care Liquid Dressing in Treatment of Diabetes Foot Ulcer: a Randomized Control Trial...
DiabetesFoot UlcerThe goal of this randomized control trial is to test the efficacy and safety of the sterile wound care liquid dressing in patients with diabetes foot ulcer in different stages. The main question it aims to answer are: Whether the sterile wound care liquid dressing have better efficacy and safety than blank control in treatment of diabetes foot ulcer in infection progressive stage? Whether the sterile wound care liquid dressing have better efficacy and safety than blank control in treatment of diabetes foot ulcer in necrosis stable stage? Whether the sterile wound care liquid dressing have better efficacy and safety than blank control in treatment of chronic wound in granulation growth stage? Participants will be assigned with a 1:1 ratio into intervention group and control group. Participants of intervention group will receive sterile wound care liquid dressing in addition with clinical optimal treatment plan. Participants of control group will only receive clinical optimal treatment plan.