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Ulcer clinical trials

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NCT ID: NCT05561140 Active, not recruiting - Sickle Cell Disease Clinical Trials

Resolution of Sickle Cell Leg Ulcers With Voxelotor

RESOLVE
Start date: May 30, 2022
Phase: Phase 3
Study type: Interventional

This study is a Phase 3, multicenter, randomized, placebo-controlled study to evaluate the efficacy of voxelotor and standard of care for the treatment of leg ulcers in participants with sickle cell disease. The study is divided into a 5 study periods: Screening, Run-in, Randomized Treatment, Open-label Treatment, and Follow-up/End of Study (EOS). The study will be conducted in approximately 80 eligible participants at approximately 20 global clinical trial sites.

NCT ID: NCT05549323 Active, not recruiting - Ulcerative Colitis Clinical Trials

A Study to Learn About the Safety, Effects and Pharmacokinetics of Study Medication (PF-07054894) for the Treatment of Ulcerative Colitis

Start date: November 7, 2022
Phase: Phase 1
Study type: Interventional

This is a study to learn if the experimental medicine (called PF-07054894) is safe, effective, and how it is processed in adult people with ulcers in the colon.

NCT ID: NCT05528510 Active, not recruiting - Colitis, Ulcerative Clinical Trials

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

ASTRO
Start date: September 13, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT05384080 Active, not recruiting - Ulcerative Colitis Clinical Trials

A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Poland

VARIETY
Start date: August 8, 2022
Phase:
Study type: Observational

The primary reason of this study is to observe current treatment options in participants receiving Vedolizumab, intravenous (IV) or subcutaneous (SC), for IBD in Poland. There is no treatment involved in this study, this is only an observational review of ongoing/initiating treatment data relating to Vedolizumab induction and maintenance treatment for IBD [including Ulcerative Colitis (UC) and Crohn's Disease (CD)].

NCT ID: NCT05291689 Active, not recruiting - Clinical trials for Inflammatory Bowel Diseases

A Phase 2a Open-Label Study to Evaluate the Efficacy and Safety of MORF-057 in Adults With UC

Start date: May 24, 2022
Phase: Phase 2
Study type: Interventional

This is an open-label, single arm, multicenter, Phase 2a study evaluating the efficacy, safety, and tolerability of MORF-057 in adult patients with Moderately to Severely Active Ulcerative Colitis (UC)

NCT ID: NCT05177835 Active, not recruiting - Ulcerative Colitis Clinical Trials

Long-term Safety and Efficacy Profile of ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis

Start date: December 3, 2021
Phase: Phase 2
Study type: Interventional

This study is an open-label study aiming at evaluating the long-term safety and the efficacy profile of ABX464 given once a day (QD) at 25 mg in subjects who have been previously enrolled in the ABX464-102 or ABX464-104 studies (OLE and maintenance studies) and who are willing to continue their treatment. All subjects will receive ABX464 given at 25 mg QD. The enrolment in this long-term study will be based on the endoscopic improvement, the willingness of the subject to carry on his/her participation and also based on investigator's judgement. Subjects will be treated with ABX464 for a maximum period of 54 months. Subjects will be followed up quarterly. After the treatment period, subjects will be followed for 4 additional weeks for safety purposes.

NCT ID: NCT05165628 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Safety, Tolerability and Efficacy of CYP-006TK in Adults With Diabetic Foot Ulcers

Start date: January 4, 2022
Phase: Phase 1
Study type: Interventional

Design: A randomised, controlled, prospective trial. Participants will be patients with non-healing diabetic foot ulcers. The study will aim to recruit 15 participants per study group (30 participants in total). Participants will be randomly allocated to one of two treatment groups: - Group 1: CYP-006TK - Group 2: Standard care This will be an open label study with respect to treatment allocation. However, the person reviewing images of the study ulcers to assess healing will be blind to the participant's treatment allocation. Participants assigned to Group 1 will be treated with CYP-0006TK dressings on 8 occasions over 4 weeks. The dressings will be changed every 3 or 4 days. After the first 4 weeks, participants in Group 1 will revert to standard care for the rest of the study. Participants assigned to Group 2 will have their ulcer treated with standard care throughout the study. Participants will attend a total of 16 scheduled visits over 24 weeks. There will be a mixture of on-site (hospital/clinic) visits, and home visits. The study will end 24 weeks after the initiation of treatment, unless the study ulcer is completely headed before then.

NCT ID: NCT05156125 Active, not recruiting - Colitis, Ulcerative Clinical Trials

VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis

Start date: November 30, 2021
Phase: Phase 2
Study type: Interventional

This is a study to understand if taking VTX002 daily as a tablet orally is safe and effective in participants diagnosed with moderate to severe ulcerative colitis (UC). Approximately 189 participants will take VTX002 Dose A, VTX002 Dose B, or matching placebo, once daily. The study consists of a 28-day Screening Period (to see if a participant qualifies for the study), a 13-week double-blind period (a participant receives either active Dose A, Dose B or Placebo), a Long-Term Extension (LTE) Treatment Period of up to 39 weeks, an Open-Label Extension (OLE) Treatment Period of up to 143 weeks, and a 2-week Follow-Up Period. The maximal duration of treatment including the Induction Period, LTE and OLE will be 36 months.

NCT ID: NCT05135130 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Retrospective Record-review Study in Patients Who Had Diabetic Foot Ulcer

Start date: October 4, 2021
Phase:
Study type: Observational

The purpose of the study is to evaluate the medical cost of illness for DFUs on the patients who had used ON101 or Aquacel® in the ON101CLCT02 trial.

NCT ID: NCT05119140 Active, not recruiting - Clinical trials for Ulcerative Colitis (Disorder)

Administration of Hydroxychloroquine (Plaquenil) to African Americans and Hispanics for the Treatment of Mild to Severe Ulcerative Colitis

Start date: June 10, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of this study is to assess the efficacy of hydroxychloroquine (HCQ) when combined with Mesalamine in reducing clinical and histologic disease activity in patients who have active mild to severe Ulcerative Colitis (UC) and also to assess the immunological effects of hydroxychloroquine in this population. These outcomes will be evaluated both clinically and experimentally. In vitro, flow cytometry will be employed to measure the expression of CTLA-4 on activated CD4+CD25+CD127- Tregs from patients prior to treatment with HCQ, and then at the end of a 4 month follow up period. Suppression assays will be used to determine the functional capacity of the patient derived Tregs. Clinically, patients will be monitored for remission as defined by reduction in patient reported stool frequency and rectal bleeding (mayo sub-score 0 or 1) and endoscopically, by improvement in mucosal appearance (mayo sub-score 0 or 1), all objective measures in the mayo score.