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Ulcer clinical trials

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NCT ID: NCT04667416 Active, not recruiting - Clinical trials for Chronic Ulcer of Lower Extremity

Safety and Preliminary Efficacy of PalinGen Flow Amniotic Tissue Allograft in Chronic Ulcers of the Lower Extremities

Start date: January 19, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the safety and preliminary efficacy of PalinGen® Flow for the treatment of chronic ulcers of the lower legs and feet.

NCT ID: NCT04630028 Active, not recruiting - Colitis, Ulcerative Clinical Trials

A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)

UNIFI Jr
Start date: March 17, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate: a) the efficacy of ustekinumab dosing in inducing clinical remission, b) safety profile of ustekinumab, and c) ustekinumab exposure (pharmacokinetics [PK]) in pediatric participants with moderately to severely active UC.

NCT ID: NCT04621006 Active, not recruiting - Ulcerative Colitis Clinical Trials

The Contact Activation System and Ulcerative Colitis

Start date: May 1, 2021
Phase:
Study type: Observational

The study aims to describe alterations in the contact activation system during active and inactive ulcerative colitis. Contact activation system measures are compared in a cross sectional (healthy controls vs. active disease) and longitudinal (active diasese vs. inactive disease) fashion.

NCT ID: NCT04607837 Active, not recruiting - Ulcerative Colitis Clinical Trials

Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis

GLADIATOR UC
Start date: April 12, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately active ulcerative colitis in adult participants.

NCT ID: NCT04583358 Active, not recruiting - Ulcerative Colitis Clinical Trials

Study of the Efficacy and Safety of AMT-101 in Subjects With Ulcerative Colitis (LOMBARD)

Start date: August 26, 2020
Phase: Phase 2
Study type: Interventional

Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis.

NCT ID: NCT04536428 Active, not recruiting - Clinical trials for Peptic Ulcer Hemorrhage

ClearEndoclip Versus EZ Clip for Upper Gastrointestinal Ulcer Bleeding

Start date: August 24, 2020
Phase: N/A
Study type: Interventional

We are going to conduct a comparative study to analyze the clinical effectiveness and user convenience of EZ clips that have been used in upper gastrointestinal ulcer bleeding and newly developed clip (ClearEndoclip, FineMedix, Taegu) in Korea. 1) Research hypothesis and purpose - This study was designed to prove the hypothesis that the hemostatic effect of newly developed endoscopic clip (ClearEndoclip, FineMedix, Taegu, Korea) is not inferior to that of EZ clip (Olympus, Tokyo, Japan) in the treatment of hemostasis for patients who visited the upper gastrointestinal ulcer bleeding. - This study was designed as a multi-center (9 institutions), open-labelled, randomized comparative clinical trial (1:1 ratio).

NCT ID: NCT04522271 Active, not recruiting - Ulcerative Colitis Clinical Trials

Resistant Starch in Pediatric Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)

Start date: August 25, 2020
Phase: N/A
Study type: Interventional

The purpose of the study is determine if a plant-based resistant starch that is optimized for the individual will target the underlying cause of inflammatory bowel disease and restore a "healthier" gut microbiome in pediatric participants with inflammatory bowel disease.

NCT ID: NCT04446936 Active, not recruiting - Pressure Ulcer Clinical Trials

Comparing Different Surgical Techniques for Coverage of Pressure Ulcer

Start date: August 1, 2020
Phase:
Study type: Observational

The Plastic, Reconstructive and Aesthetic Surgery department of Montpellier was born out of the Wound and Healing department, the first unit of this type to be created in Europe. The investigators quickly became the national leader in the management of pressure ulcers, especially in people with spinal cord injuries. Our expertise has evolved over time as well as our surgical techniques for covering ulcers, gradually over time the investigators have gone from " random " flaps to " propeller " flaps, more reliable in terms of vascularization and more logical in terms of force distribution and skin tension. The investigators found subjectively that the rate of complications was lower for the helical flaps. The investigators therefore seek to confirm this trend through a retrospective study on patients operated on in the department between January 1, 2015 and December 31, 2019.

NCT ID: NCT04259138 Active, not recruiting - Colitis, Ulcerative Clinical Trials

Determination of the Optimal Treatment Target in Ulcerative Colitis

VERDICT
Start date: February 18, 2020
Phase: Phase 4
Study type: Interventional

Disease activity and response to therapy in ulcerative colitis (UC) can be assessed by a range of endpoints including symptoms, endoscopic mucosal activity, histological disease activity, and biomarkers. This study aims to determine the optimal treatment target, which is a research priority for the management of UC both to inform clinical practice and to help inform regulatory endpoints and targets for drug development. Participants with active UC will be randomized in a 5:4:1 (initially 2:3:5) ratio to 1 of 3 groups, each with a different treatment target. Treatment targets will be defined as: - Group 1: corticosteroid-free symptomatic remission - Group 2: corticosteroid-free endoscopic + symptomatic remission - Group 3: corticosteroid-free histological + endoscopic + symptomatic remission An interim analysis was performed to assess the proportion of subjects that reached their assigned treatment target after 50 subjects in each group had reached the first 32-week assessment. The interim analysis and projections made based on target achievement rates for all subjects included in the interim analysis resulted in a recommendation to adjust the randomization ratio from 2:3:5 to 5:4:1 for Groups 1, 2 and 3 respectively as of May 5th, 2023. This change was necessary in order to complete the study with approximately 100 subjects achieving treatment target within each group.

NCT ID: NCT04181320 Active, not recruiting - Venous Leg Ulcer Clinical Trials

A Multicentre European Study to Evaluate Granulox® Used in the Treatment Pathway of Predominantly Chronic Venous Leg Ulcers (VLUs).

Granulox01
Start date: June 8, 2020
Phase: N/A
Study type: Interventional

The investigation is designed as an open label, randomized, prospective, assessor blinded, multi centre investigation. 254 evaluable subjects will be randomized to either standard of care group or standard of care with Granulox added as an adjunct therapy in predominantly venous leg ulcer subjects. Standard of care wound management will be completed, including wound cleansing, debridement if necessary and application of a suitable dressing and compression system until complete wound closure. The study will be divided into two phases. Firstly, a two week run-in period to ensure compliance to compression therapy followed by a 20 weeks treatment period starting with randomization and allocation of treatment.