Active clinical trials for "Ulcer"

This is a randomized, double-blind, placebo-controlled, phase 1b study designed to evaluate safety, tolerability, PK, and preliminary efficacy of APL-1401 in patients with moderately to severely active UC. This study comprises 3 periods including screening period (D-28~D-1), treatment period (D1-D28), and safety follow-up period(D29-D58).

This study aims to evaluate safety and benefits of early oral feeding compared to traditional delayed oral feeding in patients undergoing perforated peptic ulcer repairs. Study population & Sample size :(

This study, A3921210 is designed to evaluate the efficacy, safety and pharmacokinetics (PK) of tofacitinib in pediatric participants with moderately to severely active UC. In the US and EU, patients with prior TNFi failure or intolerance will be enrolled. Outside of the US or EU, patients having had inadequate response or intolerance to oral or IV corticosteroids or azathioprine or 6-mercaptopurine or TNFi will be enrolled. All eligible participants will initially receive open label tofacitinib at a dose expected to produce equivalent systemic exposure to that observed in adults receiving 5 mg BID with the option for individual dose increase to 10 mg BID adult dose equivalent if dose escalation criteria are met. The primary objective of this study is to evaluate the efficacy of tofacitinib based on remission in pediatric participants with moderately to severely active UC. The primary endpoint is remission by central read Mayo score following 44 weeks in the maintenance phase. Remission is defined by a Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. The study Design is an open-label Phase 3 study that includes a screening period of up to 4-weeks duration, an 8-week or 16-week induction phase, a 44-week maintenance phase, and a 24-month extension phase for pediatric participants with moderately to severely active UC. Participants will have a follow-up visit 4 weeks after the last dose of study intervention and a telephone contact 8 weeks later to assess for any adverse events (AEs)/serious adverse events (SAEs). The total maximum duration of this study will be up to 180 weeks.

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.

The purpose of the PULSE study are the followingL A.To perform post market clinical follow up (PMCF) on safety and efficacy: Safety: To confirm transient short-terms side effects and verify long-term/outstanding risks. Efficacy: To confirm the performance of PLASOMA, i.e. the beneficial effect on bacterial load. B. Determine the effect of PLASOMA on wound surface area. A secondary purpose is to examine the beneficial effects of PLASOMA on wound healing and to perform a health technology assessment (HTA). This clinical study will be an open label two-armed randomized controlled trial (RCT), performed at at least three sites (multi-center) in the Netherlands. The two arms are: Control group: Standard wound care for 12 weeks or until healing, whichever occurs first; Treatment group: Standard wound care + PLASOMA treatment for 12 weeks or until healing, whichever occurs first. The frequency of PLASOMA treatment will be determined by the treating (para)medical professional based on the number of visits they would schedule for the standard wound care at the study site. For all study subjects, the treatment frequency will be at least once per week (in order to have enough treatments for safety evaluation) and should not exceed once per day. Follow up (FU) will be performed at three timepoints for both arms: FU1: 2 weeks after end treatment period FU2: 12 weeks after end treatment period FU3: 12 months after start treatment.

The purpose of this study is to determine the safety and efficacy of using remestemcel-L, an ex vivo culture-expanded adult allogeneic bone marrow derived mesenchymal stem cell product (MSCs) delivered by targeted endoscopic delivery to treat people for medically refractory ulcerative colitis. This study will enroll adult patients with medically refractory ulcerative colitis who are planning to switch biologic therapy or undergo colectomy as the next stage in their treatment plan.

An open-label, randomised, multi-centre, dose evaluation study of the efficacy and safety of TLA Gut™ leukapheresis treatment in patients with UC. The aim of this trial is to evaluate the efficacy and safety of two different TLA Gut™ dose regimens in patients with acute exacerbation of UC. Enrolled patients will participate in a 6-week treatment phase and a 20- week follow-up phase. The treatment phase consists of two periods; 2 weeks in which patients will undergo two treatment sessions per week, followed by 4 weeks of a single treatment session per week. The follow-up phase consists of 2 visits, one visit at week 7 and the last visit at week 26. Telephone visits will be conducted between these visits. In all a patient will undergo 8 treatment visits and 2 follow-up visits. Only patients not having experienced an earlier recurrence will participate in the follow-up phase.

Although patients and physicians have shown tremendous interest in the effect of diet on ulcerative colitis, there is a lack of significant evidence for providers to make practical recommendations with. In this study, the investigators hope to find out if dietary therapy by either the Specific Carbohydrate Diet (SCD) or the Mediterranean diet will help improve ulcerative colitis symptoms for patients with mild to moderately active disease. In addition, the investigators will compare disease activity and changes in the intestinal bacterial composition in the colon that occur with the Mediterranean or the SCD diet in active ulcerative colitis. This study is proposed as a single-site randomized trial consisting of 10 study visits to Massachusetts General Hospital (MGH) over 12 weeks. Participants in this study will be randomly assigned to the SCD or Mediterranean diet. The investigators ask that participants exclusively consume their assigned diet for 6 weeks, with all meals and snacks prepared by the metabolic kitchen within MGH. Participants will need to pick up food from MGH every 5-7 days, and will meet with a study dietitian before they begin and weekly during the diet therapy. There will be a screening visit to determine eligibility for the study, as well as study visits at weeks 0, 1, 2, 4, 6, and a 10 week follow-up at MGH, in which participants will fill out questionnaires. Participants will need to provide stool samples at screening, week 6, and week 10. In addition, blood will be drawn at week 0 and week 6, and if participants are getting a clinically-indicated colonoscopy at the time of screening, up to eight research biopsies may be collected during the procedure.

This is a randomized, double-blind, placebo-controlled, multicenter, study to evaluate the efficacy, safety, and pharmacokinetics (PK) of budesonide extended-release tablets for the induction of remission in pediatric subjects, with active, mild to moderate ulcerative colitis (UC). Subjects will be permitted to continue taking background oral or rectal 5-aminosalicylate (5-ASA) products.

The primary objective of the study is to evaluate the efficacy and dose response of 2 different maintenance dose regimens of TEV-48574 subcutaneous (sc) administered every 2 weeks (Q2W) in adult participants with inflammatory bowel disease (IBD) Secondary objectives of the study are to evaluate the efficacy and dose response of 2 different maintenance dose regimens of TEV-48574 sc administered Q2W in adult participants with IBD to evaluate the safety and tolerability of 2 different dose regimens of TEV-48574 sc administered Q2W in adult participants with IBD, and to evaluate the immunogenicity of 2 different dose regimens of TEV-48574 sc administered Q2W in adult participants with IBD The total duration of participant participation in the study is planned to be 26 weeks for each individual participant. The study duration is approximately 30 months.