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NCT ID: NCT05747872 Completed - Clinical trials for Diabetic Foot Ulcers

Effectiveness of Buerger Allen Exercise Among Type 2 Diabetes Mellitus Patients With Foot Ulcer

Start date: March 10, 2022
Phase: N/A
Study type: Interventional

This study was conducted to determine the effect of Buerger Allen exercises on lower extremity perfusion and wound healing in patients with foot ulcer type 2 diabetes. The Buerger Allen exercise is a specific exercise that aims to improve circulation in the feet and legs. Buerger Allen exercise is an ideal and noninvasive therapy for diabetic patients with a diabetic foot ulcer as it is an easy-to-learn, repetitive, low-cost, and low-risk physical activity. Subjects were randomly allocated to either the control or intervention group. The ulcers and lower extremity perfusion of the patients in both the intervention and control groups were examined and measured.

NCT ID: NCT05746377 Recruiting - Upper GI Bleeding Clinical Trials

Metoclopramide in Upper Gastrointestinal Bleed

Start date: May 20, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to test if metoclopramide can improve effectiveness of endoscopic intervention in upper gastrointestinal (GI) bleeds. The main questions the investigators hope to answer is Does metoclopramide lessen the need for repeat endoscopy, interventional radiology intervention or surgery in cases of upper GI bleed? Does metoclopramide improve visibility of the GI walls in cases of upper GI bleed?

NCT ID: NCT05743153 Not yet recruiting - Ulcerative Colitis Clinical Trials

Feasibility of a Multimodal Intervention Program to Optimize Treatment Outcomes in Ulcerative Colitis

OPTIMIZE-UC
Start date: October 1, 2023
Phase: N/A
Study type: Interventional

This is a prospective, interventional pilot study to assess the feasibility and optimal timing of a multimodal intervention program in Ulcerative Colitis (UC) patients with active disease as well as in patients in remission. Secondly, to demonstrate the effects of a multimodal intervention program on individual patients level and therapy outcomes.

NCT ID: NCT05743010 Recruiting - Ulcerative Colitis Clinical Trials

A Phase 1b Study to Evaluate APL-1401 in Patients With Moderately to Severely Active Ulcerative Colitis

Start date: January 26, 2023
Phase: Phase 1
Study type: Interventional

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).

NCT ID: NCT05739864 Recruiting - Clinical trials for Active Ulcerative Colitis

Superdonor FMT in Patients With Ulcerative Colitis

Start date: February 13, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

In the last decades fecal microbiota transplantation (FMT) has been established as a highly effective option in the treatment of recurrent Clostridioides difficile infection (rCDI), with a success rate of nearly 90%. For this reason, it is recommended by international guidelines as a treatment option for this indication in clinical practice. Recently, a considerable body of evidences, suggest FMT as an effective and safe treatment in patients affected by Ulcerative Colitis (UC). In a recent meta-analysis of 324 subjects with UC, 30.4% of patients achieved both clinical and endoscopic remission after FMT compared to placebo (9.8%, P<0.00001). However, among the various published trials there is a fair variability in terms of methods and results, which are not comparable to those obtained in the rCDI. Nowadays, one of the most critical factors involved in the effectiveness of FMT in UC patients, is the choice of the donor. In addition, several studies have shown that some donors are associated with a higher clinical response rate than others. This hypothesis has been demonstrated in patients affected by irritable bowel syndrome, in which the use of a super-donor (a healthy person who has the predictive clinical and lifestyle characteristics of a healthy microbiota, and with a microbial profile associated with favorable clinical conditions) resulted in significantly higher clinical efficacy rates than placebo, similar to those obtained in rCDI (89%). Currently, studies that explored the efficacy of the super-donor FMT in UC patients are not yet available. Aim of this study is to investigate the efficacy of super - donor FMT, compared with placebo FMT, in the treatment of UC. The investigators will randomize adult patients with a recent diagnosis of UC to FMT from super - donors or placebo, by colonoscopy (first infusion) and capsules administration. Then, patients will be followed up 2 months after FMT.

NCT ID: NCT05739162 Recruiting - Obesity Clinical Trials

A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis

Start date: September 20, 2023
Phase: N/A
Study type: Interventional

The purpose of this research is to gather information on the safety and effectiveness of Endoscopic Sleeve Gastroplasty (ESG) for weight loss in a population of obese ulcerative colitis (UC) patients undergoing colectomy with eventual Ileal Pouch Anal Anastomosis (IPAA) compared to counseling on diet and lifestyle interventions alone.

NCT ID: NCT05739149 Recruiting - Non-healing Wound Clinical Trials

A Study to Evaluate Microvessel Ultrasound Imaging of Wound Healing in Patients With Chronic Ulcers

Start date: December 1, 2023
Phase: N/A
Study type: Interventional

The purpose of this research is to explore the use of high-resolution microvessel ultrasound imaging system to look for scarring and to monitor wound healing and to see if treatment affects the amount of tiny vessels and circulation around the wound.

NCT ID: NCT05737836 Not yet recruiting - Ulcerative Colitis Clinical Trials

Analyzing the Factors in Ulcerative Colitis Patients' Clinical Trial Experiences

Start date: March 2024
Phase:
Study type: Observational

Taking part in clinical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups. This study will admit a wide range of data on the clinical trial experience of Ulcerative Colitis patients to determine which factors prevail in limiting a patient's ability to join or finish a trial. It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future Ulcerative Colitis patients.

NCT ID: NCT05735665 Recruiting - Clinical trials for Ulcerative Colitis Chronic Moderate

Comparison Between Bowel Ultrasound-based Treat to Target Versus Routine Treat to Target Strategies in Ulcerative Colitis

Start date: October 3, 2022
Phase: N/A
Study type: Interventional

UC (UC) is a chronic, relapsing and destructive inflammatory disorder of the colon which can lead to organ damage and impair quality of life. Consensus guidelines recommend to go beyond resolution of clinical symptoms and achieve endoscopic remission. This long-term treatment goal in UC is commonly defined by a Mayo endoscopic subscore < 13, and is associated with prolonged clinical remission, lower rates of hospitalization and lower rates of colectomy. However, colonoscopy is an invasive and expensive procedure, unpleasant to patients, not without risks, especially during severe flares. Moreover, CS is time-consuming and expensive for the Healthcare System. Clinical symptoms correlate well with endoscopic findings, and their improvement together to normalization of FC, are currently considered the short-term and intermediate-term targets to achieve. However, while asymptomatic patients with FC < 50 mcg/g have < 5% probability to have endoscopic lesions, and conversely patients with evident rectal bleeding and persistent increased stool frequency (> 3 stools above baseline) with FC > 250 mcg/g have less than 5% chance to have endoscopic remission, in patients in the intermediate scenarios with stool frequency score (SFS) 2 or 3 or rectal bleeding score (RBS) > 0, with FC values between 50 and 250 mcg/g, the uncertainty increases and CS should not be avoided. Bowel US is a well-tolerated, non-invasive, patient friendly, cheap, easy-to-use tool to manage UC patients in clinical practice8. In addition, its ability to be performed as point-of-care bowel US may drastically change frequency of the assessment of treatment response, speeding the clinical decision-making process9. Recently, the investigators developed and externally validated non-invasive ultrasonography based criteria [Milan ultrasound criteria (MUC)] to assess and grade endoscopic activity in UC10,11. The investigators also confirmed that a MUC score > 6.2 is a valid cut-off to discriminate endoscopic activity, defined by a Mayo endoscopic subscore > 1 Bowel US is a well-tolerated, non-invasive, patient friendly, cheap, easy-to-use tool to manage UC patients in clinical practice. In addition, its ability to be performed as point-of-care bowel US may drastically change frequency of the assessment of treatment response, speeding the clinical decision-making process. Recently, the investigators developed and externally validated non-invasive ultrasonography based criteria [Milan ultrasound criteria (MUC)] to assess and grade endoscopic activity in UC14,15. The investigators also confirmed that a MUC score > 6.2 is a valid cut-off to discriminate endoscopic activity, defined by a Mayo endoscopic subscore > 1.

NCT ID: NCT05733845 Recruiting - Ulcerative Colitis Clinical Trials

Evaluation of Molecular Mechanisms of Non-response to Therapy in Patients With Inflammatory Bowel Disease

3TR
Start date: June 14, 2023
Phase: N/A
Study type: Interventional

Inflammatory bowel diseases (IBD) represent a group of immune-mediated disorders, in which currently unidentified trigger factors drive the manifestation of chronic relapsing- remitting destructive inflammatory episodes in the gut. IBD comprise two main disease entities, ulcerati\ie colitis (UC) and Crohn s disease (CD). The diseases differ in anatomical distribution, with continuous, uniform inflammation restricted to the colon in UC, and multifocal inflammation extended throughout the entire gastrointestinal tract from mouth to anus in CD. Clinical symptoms of IBD may include bloody stools, abdominal pain, fatigue, diarrhoea, fever and weight loss. Extra-intestinal symptoms occurring in up to 40% of patients, e.g. anaemia, skin lesions (e.g. erythema nodosum, pyoderma), arthritis and uveitis, and other complications directly related to the disease organ, such as fistula in CD are considered to reflect an overwhelming systemic inflammatory state. Disease onset typically manifests at age 15-35 years, men and women are almost equally affected. In addition, paediatric forms of IBD that often represent complex, se\/ere monogenic forms of the disease, are seen. The incidence rates of IBD in Europe are about 6.3 (CD) and 11.8 (UC) per 100.000 persons. With growing incidence rates and overall reduced mortality the lifetime prevalence of IBD is expected to rise. The estimated lifetime prevalence of 0.3%-0.5% of the European population corresponds to estimates of 1.5-2 million patients with IBD. Appropriate selection of therapies and their timing of introduction (decision support) in the course of IBD will be essential to reach a higher degree of disease control (across patients and within individual patients) than it is achie\led today. In many instances, comparati\ie data is missing and combinations or sequential therapies are not developed. In summary, despite some treatment successes, major challenges remain. The investigators have decided to include patients with inflammatory bowel disease (IBD) in which targeted therapies are administered as part of standard helathcare and which aims at identifiyng solid biomarker signatures as well as molecular pathways and mechanisms linked to response and non-response to therapy. Choice od medications (which are all approved for first line use) is by treating physicians. All follow-up procedures are according to standards of care.