View clinical trials related to Ulcer.
Filter by:This study will evaluate the efficacy and safety of CBP-307 in subjects with moderate to severe ulcerative colitis (UC).
Diabetic foot ulcers (DFU) are one of the most serious complications of diabetes and can lead to amputations in 85% of cases, resulting in physical, psychological, family, social and economic consequences. Research suggests that psychological factors may play an important role in DFU healing. Relaxation and hypnosis seem to contribute to faster wound healing. More research is needed to assess the effectiveness of different types of intervention on different types of wounds, in particular chronic wounds such as DFU. This study will evaluate the efficacy of relaxation and hypnosis, both with guided imagery, in DFU healing, physiological indicators (inflammatory, metabolic, oxidative stress, angiogenic, and miRNA biomarkers) of wound healing prognosis, and QoL, in patients with diabetic foot and a chronic ulcer. This study is a Randomized Controlled Study of a Psychological Intervention that aims to evaluate the efficiency of a muscle relaxation intervention with guided imagery (experimental group - EG1) compare to a hypnosis intervention with guided imagery (experimental group - EG2) and a neutral guided imagery placebo (active control group - ACG) and a group that does not receive any psychological intervention (passive control group - PCG). This study will also examine, qualitatively, the perspectives of patients with DFU on the relaxation and hypnosis interventions, in order to check its effectiveness; as well as the perspectives of informal caregivers on this adjuvant therapys. Participants must have a diagnosis of Diabetes Mellitus and Diabetic Foot; one or two chronic active ulcers at the time of assessment; and clinical levels of stress or anxiety or depression. Participants will be randomized by the four conditions - EG1, EG2, ACG and PCG - and assessed on the day of the first consultation or nursing treatment for chronic DFU (T0), two months later (T1), and six months later (T2; follow-up). Two weeks after T1, an interview will be conducted independently with patients that completed the relaxation, hypnosis, and placebo sessions, and with the informal caregivers who provided them the DFU care. The results of the present study will contribute for a better understanding of DFU progression, healing, prevention of re-ulceration and future amputations and, consequently, for the improvement of patients' quality of life.
This clinical study is a global, prospective, multi-center, randomized controlled trial to determine if the use of intravascular ultrasound (IVUS) as an adjunctive imaging modality and as an interventional treatment guide will result in a more accurate diagnosis of deep vein occlusion (DVO), will guide optimal therapy, and will provide better clinical outcomes with reduced cost of care for patients presenting with persistent venous leg ulcers (VLUs).
In this prospective, non-randomized cohort study, real-time intraoperative visualization using near-infrared-fluorescence by indocyanine green injection (ICG-NIRF) is performed at three time points during ileal pouch reconstruction. Postoperatively, a detailed software-based assessment of each pouch recording is performed to determine the objective ICG-NIRF perfusion rate, which is then correlated with the 30 day postoperative clinical outcome including occurrence of anastomotic leak of the pouch.
In this prospective, non-randomized cohort study, real-time intraoperative visualization using near-infrared-fluorescence by indocyanine green injection (ICG-NIRF) is performed at three time points during ileal pouch reconstruction. The intraoperative imaging findings are then analysed and correlated with the 30 day postoperative clinical outcome including occurrence of anastomotic leak of the pouch.
Together with Crohn's disease (CD), ulcerative colitis (UC) is one of the major forms of inflammatory bowel diseases (IBD).Currently, no curative therapy is available, since the pathophysiology of this disease is incompletely understood (1-3) and clinical practice demonstrates that current therapies induce remission in subgroups of patients only. Scientific evidence suggests that colitogenic immune responses can be controlled by increasing the number of circulating regulatory T cells (Treg) (4). The production of large numbers of autologous Treg is possible by isolation of CD25+ cells from the whole blood of a patient and subsequent ex vivo expansion in the presence of the immunomodulatory drug rapamycin, Interleukin-2 (IL-2) and CD3/CD28 expander beads (5). ER-TREG 01 is a single-center, open-label, fast-track phase I dose-escalation study designed to assess the safety profile and maximal tolerated dose (MTD) of a single infusion of ex vivo expanded autologous Treg in patients with active ulcerative colitis.
Umbilical cord blood mononuclear cells (MNC) may improve the wound repair ability. This study aims to investigate the role of MNC in refractory diabetic foot ulcer by comparing the combination of PRP and MNC with PRP alone.
Skin ulcer is a common disease with complicated etiopathogenes, which makes it hard to be cured. It has been reported that photodynamic therapy (PDT) can be used to treat skin ulcers which were caused by different diseases. However, PDT is an expensive treatment and patients always experience obvious pain during or after the treatment, which hinders the application of PDT in skin ulcer. Our previous study found that PDT using a low concentration of 5-Aminolevulinic acid (ALA) could promote the healing of skin ulcer without obvious adverse reactions, which suggests us that low concentration ALA-PDT might be an efficient and cost effective treatment in skin ulcer. To further investigate the use of low concentration ALA-PDT in skin ulcer, we plan to recruit patients with skin ulcers caused by different diseases, and divide these patients into different groups according to their causes of disease, and then treat them using low concentration ALA-PDT to observe the healing process of skin ulcer. This study could further optimize and promote the use of low concentration ALA-PDT in skin ulcer.
Multi-center, prospective,randomized controlled study on the speed of healing, life quality and cost-effectiveness of the treatment with a blue light medical device (EmoLED) versus existing Standards Of Care (SOC) for patients with leg ulcers. The aim of LUCE - "Leg Ulcers Standards of Care Enhancement" clinical trial is to verify the clinical efficacy of a portable battery-powered device blue LEDs based. This study aims to compare the existing SOC (consisting in two visits per week) to a protocol that requires only one visit per week, during which the EmoLED treatment is administered in addition to the current therapy. It is expected to register a difference in efficacy between EmoLED Group and SOC Group, in terms of "healing rate", intended as a reduction of the wound area, but also as a progress, in a broad sense, of the overall clinical situation of the lesion, in terms of pain and quality of life. -Endpoint- The primary endpoint is the comparison of the outcomes in terms of healing rate of lesions treated with SOC (SOC Group) versus lesions treated with EmoLED (EmoLED Group), on week 16th. Patients 80 patients will be recruited (40 patients per group), following these inclusion/exclusion criteria: Inclusion criteria: - Subjects suffering from venous and mixed skin ulcers; - Presence of a lesion < 100 cm² of area and < 1 cm in depth; - Men and women ≥ 18 years old; - The patient must be able to understand the aims of the clinical trial and provide informed consent in writing; - Chronicity of the lesion: at least 8 weeks. Exclusion criteria: - Patients who participated in clinical trials about skin ulcers healing during the previous month; - Patients who are not able to understand the aims of the trial; - Patients with pressure ulcers; - Patients with diabetic foot ulcers; - Patients with circumferential leg ulcer (due to the difficulties in analysing the pictures); - Patients with clearly infected ulcers or with systemic infection; - Patients with ulcers caused by critical ischemia; - Patients with a self-harm past that can purposely alter the process of healing; - Patients with psychiatric disorders; - Pregnancy or breast feeding; - Patients with neoplasms or other diseases involving the use of cytostatic or immunosuppressive drugs; - Patients with limited lifespan; - Patients with photosensitizing illnesses or that take photosensitizing drugs. All inclusion and exclusion criteria must be satisfied before recruitment. Any concomitant phar-macological therapy must be maintained. -Medical and surgical procedures- The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied. Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic la-tex-free bandage will be carried out. The treatment with EmoLED, in addition to the SOC, will be performed during each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion. In case of multiple lesions matching with both inclusion and exclusion criteria, they will be all treated following the same protocol, depending on the group to which the patient belongs; in this case the Principal Investigator will fill out a data-collection form and take pictures just of the le-sion with the wider area. -Follow up procedure- The patient is called upon to go to the follow-up check after 4 weeks from the healing or, other-wise, from the end of the trial (16 weeks). The follow-up visit will be used to confirm the occurred healing and verify the absence of relapses and/or undesirable effects (if the wound appeared completely healed) or to value the healing progress for the unhealed lesions.
In this FinUC study we are trying to find out the efficacy and safety of the Fecal microbiota transplantation (FMT) in newly diagnosed active ulcerative colitis patients. The study group with newly diagnosed active ulcerative colitis receive an FMT via colonoscopy from a tested general donor, frozen and thawed from a fecal bank at week 0 and at week 4 as an enema at the study nurse´s visit. The control group will be given colored water. The main aim of the FinUC study is to determine how the FMT change of the gut microbiota composition in newly diagnosed active ulcerative colitis patients. The other aim is to determine efficacy and mechanisms of fecal microbiota transplantation.