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Ulcer clinical trials

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NCT ID: NCT04738942 Recruiting - Ulcerative Colitis Clinical Trials

A Study of Intravenous Vedolizumab Administered Every 4 Weeks in Japanese Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease

Start date: June 4, 2021
Phase: Phase 3
Study type: Interventional

The main aim of the study is to learn if 4-weekly vedolizumab improves symptoms of Japanese participants with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD). Vedolizumab is commercially available in Japan for 8-weekly treatment but not for 4-weekly treatment. The study doctors will also monitor side effects from the study treatment. This study will take place in Japan. At the first visit, the study doctor will check if each person can take part. For those who can take part, participants will receive vedolizumab intravenously once every 4 weeks. After 3 infusions of vedolizumab (which will be 12 weeks of treatment), the study doctor will assess if symptoms of the participants have improved. Participants who do not have improved symptoms after 12 weeks of treatment with vedolizumab will stop this treatment. Then, they will visit the study clinic 16 weeks after their last infusion of vedolizumab for a final check-up. Participants who have improved symptoms after 12 weeks of treatment with vedolizumab will continue to receive vedolizumab every 4 weeks. Then, after their last infusion of vedolizumab, the participants will visit the study clinic 16 weeks later for a final check-up. Finally, the study clinic will make a phone call to each participant 6 months after their last infusion to check if they have any health problems.

NCT ID: NCT04737941 Recruiting - Venous Ulcer Clinical Trials

Finnish Venous Ulcer Study (FINNULCER Study)

Start date: February 26, 2021
Phase: N/A
Study type: Interventional

This multicenter randomized controlled trial compares immediate foam sclerotherapy vs. scheduled endovenous treatment in patients with venous ulceration.

NCT ID: NCT04723134 Recruiting - Diabetic Foot Ulcer Clinical Trials

Evaluation of a Folic Acid Wound Treatment (FAWT) for Chronic, Early-Stage Diabetic Foot Ulcer (DFU) Healing

Start date: December 1, 2021
Phase: Phase 2
Study type: Interventional

This is a twelve-week single-center, randomized, double-blind, clinical study to evaluate the safety and efficacy of a folic acid wound treatment (FAWT) versus Placebo in the promotion of healing of chronic, early stage diabetic foot ulcer (ES-DFU) wounds. Male and female Veterans with type-2 diabetes mellitus and chronic ES-DFUs acceptable to the study inclusion/exclusion criteria will be considered for enrollment.

NCT ID: NCT04721873 Recruiting - Obesity Clinical Trials

Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients

Start date: December 18, 2020
Phase: Phase 2
Study type: Interventional

Approximately 20-40% of patients with ulcerative colitis (UC) are obese. The investigators have demonstrated that obesity adversely impacts disease course in patients with UC, leading to higher risk of persistently active disease, surgery, hospitalization, and treatment failure, particularly in biologic-treated patients. Intentional weight loss is effective in improving disease outcomes in patients with inflammatory arthritis, but there is limited data on its impact in UC. While dietary interventions for weight loss have limited efficacy and endoscopic bariatric interventions may be too invasive in patients with UC with active gastrointestinal symptoms, pharmacological weight loss with a highly effective oral agent may be a novel strategy to induce weight loss and augment the efficacy of biologic therapy in UC. Hence, the investigators are conducting a pilot, phase 2A, 22-week, randomized, placebo-controlled clinical trial of phentermine-topiramate in obese patients with active UC starting on a new biologic agent (infliximab, adalimumab, golimumab, vedolizumab). The overall objective is to (1) evaluate the efficacy, safety and tolerability of phentermine-topiramate, and (2) to assess the impact of pharmacological weight loss on clinical outcomes, inflammatory burden and biologic trough concentration in patients with UC. The central hypothesis is that phentermine-topiramate will be safe, effective, and well tolerated in patients with UC, and weight loss would achieve higher rates of clinical and biochemical remission, and higher biologic trough concentration.

NCT ID: NCT04718818 Recruiting - Ulcerative Colitis Clinical Trials

An Active and Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis

Expedition
Start date: August 7, 2018
Phase: Phase 2
Study type: Interventional

The present study D5272C00001 (Legacy # 3151-201-008) seeks to evaluate the efficacy and safety of brazikumab versus placebo in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by improvement of symptoms and of colonic mucosal appearance as observed on endoscopy.

NCT ID: NCT04716790 Recruiting - Diabetic Foot Ulcer Clinical Trials

Comparison Between the Effect of Ultrasound Debridement and Conventional Treatment in Diabetic Foot Ulcers (DFU).

Start date: April 20, 2021
Phase: N/A
Study type: Interventional

The investigators aimed to elucidate the effects of ultrasound debridement on the area and healing of diabetic foot ulcers compared to their conventional treatment.

NCT ID: NCT04714749 Completed - Venous Leg Ulcer Clinical Trials

Feasibility and Tolerance Study for the Treatment of Varicose Ulcers by Cyanoacrylate Glue (ETUVVE)

ETUVVE
Start date: January 21, 2021
Phase: N/A
Study type: Interventional

Ulcers of the lower limbs are a major public health problem whose management needs to be further improved, particularly in terms of healing time, prevalence and recurrence rate. Ulcers of venous origin, or mixed arteriovenous and predominantly venous, represent the majority of leg ulcers with an estimated proportion of 70 to 80% of cases. These are painful, disabling conditions that are difficult to treat in a lasting way. This study focuses on a treatment strategy with endovascular glue. The advantage of treating ulcers with cyanoacrylate glue is the possibility of occluding the great saphenous vein over its entire length, freeing itself from neurological complications secondary to endovenous thermal techniques (laser, radiofrequency), as well as the possibility of treating by direct puncture any perforators or tributaries feeding the ulcer. This treatment strategy would improve the healing process for a lasting resolution of this pathology. This study aims to describe the feasibility and tolerance of this type of treatment in the resolution of varicose ulcers.

NCT ID: NCT04706793 Completed - Ulcerative Colitis Clinical Trials

Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)

Start date: December 25, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment in adult Japanese participants with moderately to severely active ulcerative colitis (UC). This study is an extension of study APD334-302 (NCT03996369). Participants will continue with the same blinded treatment assigned in Study APD334-302 for a total treatment duration of 52 weeks (12 weeks in Study APD334-302 plus 40 weeks in Study APD334-308).

NCT ID: NCT04703569 Completed - Venous Ulcers Clinical Trials

Effect of Compressive Therapies on the Healing of Venous Ulcers

VENOS
Start date: December 2, 2020
Phase: N/A
Study type: Interventional

The objective of the study is to compare the effect of two treatments on the healing of venous ulcers in follow-up people in two Primary Health Services, in a city in southern Brazil. The two treatments that will be tested are: (1) the high compression elastic bandage and (2) Unna boot. The two treatments are indicated for the treatment of people with venous insufficiency and who have an active ulcer. The treatment will last 26 weeks (6 months). Once a week, during 26 weeks, a nurse will perform the dressing and will apply the therapy high compression elastic bandage or Unna boot according to a drawing and in every two weeks an evaluator will assess the characteristics of the ulcers and the size.

NCT ID: NCT04702542 Active, not recruiting - Peptic Ulcer Clinical Trials

To Develop Methods for the Rehabilitation of Chronic Gastroduodenal Pathology in Children.

Start date: January 4, 2020
Phase: N/A
Study type: Interventional

The object of the study will be children and adolescents from 6 to 15 years old, living in the city of Tashkent and in the Tashkent region. We will study patients with various clinical forms of chronic gastroduodenal pathology (CGDP). The effect of enteral oxygen therapy in the recovery of patients with CGDP due to the positive effect of the active form of oxygen on the hematological system and on the regenerative processes in the gastrointestinal tract will be studied. At the same time, the effect of enteral oxygen therapy on enhancing the effectiveness of eradication therapy during the treatment of carrier Helicobacter pylori due to the neutralization of the products of urea hydrolysis around bacteria under the action of reactive oxygen species will be studied.