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Ulcer clinical trials

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NCT ID: NCT06260267 Recruiting - Ulcerative Colitis Clinical Trials

A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis

Start date: March 12, 2024
Phase: Phase 1
Study type: Interventional

To explore the safety of FE 999322 (microbiota suspension) and FE 999324 (microbiota capsule) versus placebo in subjects with active mild to moderate ulcerative colitis (UC).

NCT ID: NCT06260163 Recruiting - Colitis, Ulcerative Clinical Trials

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

QUASAR Jr
Start date: January 19, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.

NCT ID: NCT06257875 Recruiting - Ulcerative Colitis Clinical Trials

A Study to Assess Adverse Events and Change in Disease Activity From Intravenous (IV) and Subcutaneous (SC) Lutikizumab in Adult Participants With Active Ulcerative Colitis

Start date: March 23, 2024
Phase: Phase 2
Study type: Interventional

Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). The purpose of this study is to assess how safe and effective lutikizumab is in adult subjects with UC and how lutikizumab compares to adalimumab in the treatment of UC. Adverse events and changes in disease activity will be assessed. Lutikizumab is an investigational product being developed for the treatment of UC. Participants are placed in groups called treatment arms. Each group receives a different treatment. In the Induction Period, participants will be randomized into 1 of 3 arms receiving lutikizumab Dose 1, lutikizumab Dose 2, or adalimumab. In the Maintenance Period, participants who responded to lutikizumab will be randomized into 1 of 2 arms of lutikizumab maintenance and participants who responded to adalimumab will continue to receive adalimumab. All participants who did not achieve clinical response per modified Mayo Score at the end of the Induction period will receive open label lutikizumab. Around 200 adult participants with UC will be enrolled at approximately 280 sites worldwide. In the Induction Period, participants will be randomized to receive intravenous (IV) and subcutaneous (SC) lutikizumab or SC adalimumab for 12 weeks. At the 12 week mark, participants who are on lutikizumab who have responded to treatment will be re-randomized to receive SC lutikizumab at different intervals until Week 52. Participants who are on adalimumab who are responding to treatment will continue to receive adalimumab until Week 52. Participants who do not respond to treatment will receive open-label SC lutikizumab until Week 52. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT06256575 Not yet recruiting - Clinical trials for Scleroderma, Systemic

Study of Diosmin-Diosmetin for the Treatment of Digital Ulcers in Systemic Sclerosis

Start date: July 15, 2024
Phase: N/A
Study type: Interventional

This study is performed to consider the safety and healing ability of diosmin in patients with systemic sclerosis (scleroderma) and open sores on their fingers (digital ulcers). Two (2) out of three (3) participants will receive active product. The participants will have four (4) visits over eight (8) weeks. Physical exams and photos will be performed. A variety of questions will be asked describing level of pain and lifestyle changes.

NCT ID: NCT06255288 Recruiting - Venous Leg Ulcer Clinical Trials

Time to Heal (Wound, Healing, Dialogue, Nutrition)

SNAK
Start date: January 23, 2024
Phase: N/A
Study type: Interventional

The objective of this study is to examine the feasibility, acceptability, fidelity, and outcome of a nurse-led nutritional intervention for patients with leg ulcers in a outpatient clinics. The intervention consists of a structured dialogue and patient information on key lifestyle behaviours to improve wound healing. Furthermore, the intervention includes protein supplement.

NCT ID: NCT06254950 Recruiting - Ulcerative Colitis Clinical Trials

A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis

Start date: March 29, 2024
Phase: Phase 2
Study type: Interventional

The main aim of this study is to learn if TAK-279 reduces bowel inflammation and symptoms compared to placebo. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate any problems. The participants will take capsules of either TAK-279 or placebo for up to 3 months (12 weeks). Then all the participants will receive TAK-279 for the rest of the treatment part of the study (1 year or 52 weeks). During the study, participants will visit their study clinic several times.

NCT ID: NCT06249763 Not yet recruiting - Ulcerative Colitis Clinical Trials

Effects of Gluten Free Diet in Ulcerative Colitis

Start date: February 2024
Phase: N/A
Study type: Interventional

The goal is to evaluate gastrointestinal symptoms and fatigue levels during a period of eating gluten free compared to a period of high gluten consumption in individuals with confirmed Ulcerative Colitis, and to identify clinical characteristics in the blood and microbiome of those improving from a gluten free diet. The main questions, the project aims to answer are: - What is the effect of eating gluten free on patient-reported gastrointestinal symptoms in patients with Ulcerative Colitis? - What is the effect of eating gluten free on patient-reported fatigue levels in patients with Ulcerative Colitis? - What are clinical differences between those improving and not improving on fatigue levels and gastrointestinal symptoms? During two study periods of one week each, participants will be eating gluten free supplemented with daily granola bars without and with high gluten content, respectively. During each active week, participants are asked to: - Eat gluten free and two daily granola bars delivered by the research team - Collect blood, stool and urine samples - Answer questionnaires about their symptoms, disease course, habitual lifestyle, and compliance to the protocol

NCT ID: NCT06236750 Recruiting - Diabetic Foot Ulcer Clinical Trials

Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds

Start date: August 4, 2023
Phase: N/A
Study type: Interventional

The purpose of this survey is to observe the efficacy and safety of EPIFIX® dehydrated human amnion/chorion membrane (DHACM) for the treatment of intractable diabetic foot ulcers or venous leg ulcers.

NCT ID: NCT06231771 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Safety and Efficacy of Stem Cells for Diabetic Foot Ulcer

Start date: May 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of this clinical trial is to evaluate the effectiveness and safety of Wharton-Jelly mesenchymal stem cells administered around the ulcer site in patients with nonhealing diabetic foot ulcers. The key inquiries it seeks to address include the percentage of patients achieving complete healing/closure of the specified ulcer at any point during the 6-week period, the duration required for the complete closure of the target ulcer, and the nature and occurrence of adverse events (AEs), along with the total number of AEs and the proportion of patients experiencing AEs. Patients meeting the eligibility criteria will receive either allogeneic mesenchymal stromal cells (MSC) or a placebo. The peri-ulcer injection of umbilical cord MSC or placebo will be administered at multiple locations, around the ulcer. Subsequent follow-up after the administration of umbilical cord MSC or placebo will be conducted to monitor and observe the progress of ulcer healing.

NCT ID: NCT06231264 Recruiting - Ulcerative Colitis Clinical Trials

Transcutaneous Electrical Acustimulation in the Treatment of Mild to Moderate Ulcerative Colitis

Start date: January 19, 2024
Phase: N/A
Study type: Interventional

The aim of this study was to evaluate the efficacy and safety of transcutaneous electrical acustimulation in patients with mild to moderate ulcerative colitis.