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Ulcer clinical trials

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NCT ID: NCT06283979 Not yet recruiting - Osteomyelitis Clinical Trials

A Randomized Controlled Phase II Trial of STIMULAN VG vs Standard of Care (SoC) for the Treatment of Osteomyelitis Associated With Stage IV Pressure Ulcers.

BLADE OPU2
Start date: July 1, 2024
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to assess the safety, tolerability and between-group effect size of STIMULAN VG (with debridement) and a course of systemic antibiotics to standard of care (debridement and systemic antibiotics only) for the treatment of osteomyelitis associated stage IV pressure ulcers.

NCT ID: NCT06278935 Not yet recruiting - Diabetic Foot Ulcer Clinical Trials

Lifestyle Tailored Offloading for Diabetic Foot Ulcers

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

The goal of this pilot clinical trial is to develop and test a tailored occupational therapist-led lifestyle-focused intervention to aid patients in improving diabetic foot ulcer care. The main questions it aims to answer are to determine the acceptability and feasibility of taking a tailored lifestyle-focused approach as part of comprehensive diabetic foot ulcer management. Patient participants with DFUs who require offloading treatment will receive the tailored lifestyle-focused self-management intervention.

NCT ID: NCT06273384 Not yet recruiting - Clinical trials for Helicobacter Pylori Infection

Diagnostic Performance of CIM for Helicobacter Pylori Infection in Patients With Peptic Ulcer Bleeding

CIM
Start date: March 1, 2024
Phase:
Study type: Observational

The goal of this cross-sectional study is to evaluate the efficacy of current infection marker (CIM) method for H. pylori detection. The main questions it aims to answer are: - To evaluate the efficacy of CIM method for H. pylori detection compared to rapid urease test(RUT), histopathology, polymerase chain reaction (PCR), and urea breath test (UBT) in patients who presented with upper gastrointestinal hemorrhage from peptic ulcer, and their sensitivity, specificity, accuracy, positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio, and negative likelihood ratio. - To evaluate the advantages of CIM method for H. pylori detection comparing to RUT, histopathology, PCR, and UBT in patients who presented with upper gastrointestinal hemorrhage from peptic ulcer as net reclassification index (NRI). - To study the associated factors in false negative value of H. pylori detection methods with CIM, RUT, histopathology, PCR, and UBT.

NCT ID: NCT06267651 Not yet recruiting - Clinical trials for Early Detection of Complication of Ulcerative Colitis

Value Of ACE Index (Albumin, CRP And Endoscopy) In Predicting Intra Venous Steroid Response In Acute Severe Ulcerative Colitis In Assiut University Hospitals

Start date: January 2025
Phase:
Study type: Observational

1. Determine if the ACE index can predict resoponse to I V steroid in Acute severe ulcerative colitis 2. identify on admission a high-risk population who may beneft from earlier second line medical treatment or surgical intervention. ( steroid non responder groups )

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: May 15, 2024
Phase: N/A
Study type: Interventional

This study is performed to consider the safety and healing ability of diosmin-diosmetin in patients with systemic sclerosis (scleroderma) and open sores on their fingers (digital ulcers). . The study will include 21-45 patients who will randomly be given either active product or inactive product (placebo). Two (2) out of every three (3) patients enrolled will receive active product. The patients will have four (4) visits over eight (8) weeks. At each visit physical exams and photos will be performed. Each person will also be asked a variety of questions describing level of pain and any changes to their lifestyle. Diosmin-Diosmetin is a naturally occurring compound found in citrus fruits and vegetables known as flavonoids. This product has been used to treat poor blood circulation in a variety of countries.

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: 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: NCT06228352 Not yet recruiting - Ulcerative Colitis Clinical Trials

Role of Bile Acids and Microbiota in Clostridioides Difficile Infection in Ulcerative Colitis

ABRICO
Start date: March 2024
Phase:
Study type: Observational

Ulcerative Colitis (UC) is a chronic Inflammatory Bowel Disease characterized by chronic inflammation of the colon. Composition of gut microbiota of UC patients is abnormal (dysbiosis). Ulcerative Colitis patients have an increased risk of Clostridioides difficile infection (CDI) and CDI complications (colectomy, death, recurrence). The reason for this increased risk in IBD patients is not fully understood. The decrease in the proportion of secondary bile acids, induced by microbiota dysbiosis in patients with UC could favor C. difficile infection. The main objective of the study is to describe the composition of bile acids (primary and secondary) in children followed for UC during relapse with or without CDI and to compare it to children with UC in remission and healthy controls. The composition of fecal microbiota will be also describe to correlate dysbiosis and bile acid abnormalities. And finally some fecal biomarkers will be study : short chain fatty acids, metabolic pathway of Tryptophan, and fecal Calprotectin.

NCT ID: NCT06213857 Not yet recruiting - Ulcerative Colitis Clinical Trials

Beneficial Effect of Silymarin in Ulcerative Colitis

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

The goal of this clinical trial is to evaluate the possible beneficial effect of silymarin in Ulcerative Colitis adult patients receiving mesalamine. This is trial that will be conducted on 44 adult patients with newly diagnosed Ulcerative Colitis. Patients will be enrolled after obtaining an informed consent from them or their guardians. Patients will be recruited from Rajhy Hospital Outpatient Clinics and Health Insurance Outpatient Clinics at Mabarra Hospital in Assiut, Egypt. The patients will be randomized based on hospital admission days into two groups: - Group Ⅰ (control group): 22 patients will receive mesalamine (4g\day induction & 2g\day maintenance) only for 6 months. - Group Ⅱ (silymarin group): 22 patients will receive mesalamine (4g\day induction & 2g\day maintenance) and silymarin (140 mg\day) for 6 months. The primary outcome will be clinical improvement defined as a 2 point or more decrease in the Mayo score from baseline. The secondary outcomes will be the change in the level of fecal calprotectin, superoxide dismutase and TNF-α.

NCT ID: NCT06207825 Not yet recruiting - Clinical trials for Computer-aided System

Accuracy of Computer-aided (CADx) System in Real-time Characterization of Colorectal Ulcerative Diseases

Start date: January 2024
Phase:
Study type: Observational

The goal of this observational study is to test the diagnostic accuracy of the newly developed CADx system in predicting the histopathology of colorectal ulcers when compared to expert endoscopists. The main question it aims to answer are to demonstrate whether the newly developed CADx system has a high-level diagnostic accuracy in predicting characterization of colorectal ulcerative diseases. It is a multi-center study with two phases. The first retrospective phase is the development and validation of a CADx system by feature extraction from endoscopic photos and videos. The second prospective phase is the evaluation and comparison of the diagnostic accuracy between the CADx system, expert endoscopists and junior endoscopists.