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Ulcer clinical trials

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NCT ID: NCT03808506 Withdrawn - Ulcerative Colitis Clinical Trials

Relationship Between Baseline Burden of Disease and TDM in Ulcerative Colitis

Start date: September 1, 2019
Phase:
Study type: Observational

Ulcerative colitis (UC) is a chronic inflammatory bowel disease which often follows a relapsing/remitting course. Anti-TNF therapies are proven to be effective in UC and studies indicate that having adequate drug levels correlate with improved patient outcomes. It is unknown, however, if a high burden of disease at baseline impacts drug utilization or loss. In this study, we investigate whether measures of high burden of disease (fecal calprotectin, bowel ultrasound, and colonoscopy) at baseline predicts low drug levels after standard anti-TNF induction therapy.

NCT ID: NCT03675269 Withdrawn - Diabetic Foot Ulcer Clinical Trials

Adjunctive Hyperbaric Oxygen Therapy (HBOT) for Lower Extermity Diabetic Ulcer:

Start date: September 5, 2018
Phase: N/A
Study type: Interventional

Diabetic foot ulcers are associated with high risk of amputation. About 50% of patients undergoing non-traumatic lower limb amputations are diabetics5. The 5-year amputation rate is estimated to be 19% with a mean time to amputation 58 months since the onset of an diabetic foot ulcer6.Because infection and tissue hypoxia are the major contributing factors for non-healing diabetic foot ulcers, hyperbaric oxygen therapy (HBO) carries a potential benefit for treating these problematic wounds that do not respond to standard therapy. The role of oxygen in the wound healing cascade and subsequent combatting action against bacterial invasion, especially anaerobes, is well documented.14 Delayed or arrested healing and the development of infection is a direct result from decreased perfusion and poor oxygenation of tissue.15 The presence of wound hypoxia is an major etiological pathway in the development of chronic non-healing diabetic foot ulcers

NCT ID: NCT03627052 Withdrawn - Clinical trials for Moderate to Severe Ulcerative Colitis

A Study to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis

Start date: September 20, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of itacitinib in participants with moderate to severe ulcerative colitis (UC).

NCT ID: NCT03544788 Withdrawn - Venous Leg Ulcer Clinical Trials

Evaluation of Cirvo™ Mobile Compression Device for Treatment of Venous Leg Ulcers

HEAL I
Start date: June 30, 2019
Phase: N/A
Study type: Interventional

This study in venous leg ulcer (VLU) patients will evaluate the use of Cirvo™ therapy for the treatment of VLU when applied for a minimum of two hours daily for up to 12 weeks.

NCT ID: NCT03309865 Withdrawn - Ulcerative Colitis Clinical Trials

Evaluating the Combined Effect of Vedolizumab and Semi-Vegetarian Diet on Ulcerative Colitis.

Start date: December 25, 2017
Phase: Early Phase 1
Study type: Interventional

Research of fecal microflora and dysbiosis status in ulcerative colitis (UC) has shown its influential role on the disease pathogenesis. Vedolizumab, a humanized monoclonal antibody blocking the migration of leukocytes into inflamed intestinal tissue, has been shown to achieve remission in about half of active UC patients. Dietary intervention in UC patients has not been adequately studied. There is a significant clinical gap to achieve a higher efficacy and better clinical outcomes on the treatment of active UC patients. This study proposes to assess the integrated effect of normalization of intestinal dysbiosis through a structured semi-vegetarian dietary intervention in active UC patients who will also be under the standard of care medical therapy (vedolizumab). Significance of investigation for innovation: The pathogenesis of UC has been found to be multi-factorial, including host genetics and dysregulated inflammatory response, and recent research has shown the influential role of gut environmental factors - dysbiosis which has been found the key feature of UC. Vedolizumab has been shown effective (e.g. 47% clinical response rate vs. 25% in placebo group) and is part of the current standard of care treatment in UC. With the observation of drastic increase of IBD patients in Asia, in which has historically low incidence of IBD, it is generally accepted that the westernized diet and urbanization of life style play an important role in IBD pathogenesis. Enteral nutritional therapy has been demonstrated effective in pediatric Crohn's disease (CD) patients; however, the application to adult IBD patients has not been widely accepted partly because of the compliance issue. In addition, unlike CD, neither enteral nutrition nor non-enteral nutrition in patients with active UC has been adequately studied. Therefore, this study proposes a novel approach to assess the integrated effect of a structured dietary intervention in active UC patients who will also be under the current standard of care medical therapy (vedolizumab). After this study achieves the proposed primary or secondary outcome, it will further support the hypothesized synergistic interactive therapeutic effect between the normalization of dysbiosis in the intestine (through dietary intervention) and anti-inflammatory biologics (vedolizumab).

NCT ID: NCT03296436 Withdrawn - Diabetic Foot Ulcer Clinical Trials

A Pilot Study to Assess the Efficacy of NEOX® CORD 1K® in the Treatment of Complex Diabetic Wounds

Start date: January 2020
Phase: Early Phase 1
Study type: Interventional

Patients presenting to Johns Hopkins with a diabetic ulcer classified by the UT Grade 2 or 3 who meet all of the inclusion and none exclusion criteria and give their informed consent, will receive an application of NEOX CORD 1K in addition to standard of care procedures. Those patients will be seen in follow-up at weekly visits until the wound closes and epithelize, achieving complete closure. Subjects that do not achieve complete ulcer closure prior to or at the end of the 16 treatment weeks will exit the study.

NCT ID: NCT03237260 Withdrawn - Ulcerative Colitis Clinical Trials

An Open Label Single-arm Phase 4 Study of Vedolizumab in Subjects With Newly Diagnosed Active Ulcerative Colitis

Start date: July 1, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this research study is to determine whether starting the drug vedolizumab earlier than its FDA approved use can lead to better control of UC then using older drugs that we have historically used to treat UC. Vedolizumab is FDA-approved to be used after initial Corticosteroid treatments have failed or other UC treatments have failed. We will study if using vedolizumab as an early treatment for your UC will allow you to get off corticosteroids and prevent UC from worsening and requiring surgery. Vedolizumab is given intravenously initially every 2 weeks and then every 8 weeks.

NCT ID: NCT03211910 Withdrawn - Healing Ulcer Clinical Trials

Sacral Savers: Study of Prevention and Enhanced Healing of Sacral and Trochenteric Ulcers

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

The purpose of the study is to investigate the ability of the product "Sacral Saver," to prevent and /or help healing bed sores.

NCT ID: NCT03038009 Withdrawn - Clinical trials for Proton Pump Inhibitor

Proton Pump Inhibitor Prevent Dual Antiplatelet Agents Induced Gastrointestinal Ulcer After Coronary Artery Bypass Graft

DACAB-GI-2
Start date: October 2018
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether 12-month prophylactic treatment with pantoprazole is superior to 1-month therapy without major cardiovascular events (MACE) increased significantly, in prevention of dual antiplatelet therapy (DAPT)-induced upper gastrointestinal (GI) mucosal injury after coronary artery bypass graft (CABG) surgery. The potentially serious harm of DAPT on gastroduodenal mucosa will be assessed by esophagogastroduodenoscopy (EGD).

NCT ID: NCT03034161 Withdrawn - Pressure Ulcer Clinical Trials

Thermal Imaging to Identify Distinct Temperature Patterns in Various Stages of Pressure Ulcers

Start date: April 1, 2019
Phase:
Study type: Observational [Patient Registry]

40 patients total with pressure ulcers with a decubitus pressure ulcer will be included in this study. Ten patients with a Stage I, II, III, and IV decubitus pressure ulcer will be included to be analyzed with a thermal imaging camera. Thermal imaging of the various stages of pressure ulcer will be analyzed to determine if a recognizable pattern of thermal distribution can be identified which can then be applied to identify patients at risk of developing pressure ulcers at an earlier stage in their hospital course.