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Ulcer clinical trials

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NCT ID: NCT02533726 Completed - Pressure Ulcer Clinical Trials

Optimal Patient Turning for Reducing Hospital Acquired Pressure Ulcers

LS-HAPU
Start date: August 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to test whether optimal patient turning, strictly every 2 hours with at least 15 minutes of tissue decompression, reduces the occurrence of hospital acquired pressure ulcers.

NCT ID: NCT02522780 Completed - Ulcerative Colitis Clinical Trials

Mesalamine 2 g Sachet for the Maintenance of Clinical and Endoscopic Remission in Ulcerative Colitis (UC)

Start date: February 1, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this trial was to investigate the safety and efficacy of mesalamine 2 g extended release granules (sachet) once a day (QD) for maintenance of clinical and endoscopic remission in subjects with UC. The duration of treatment for each subject was 6 months.

NCT ID: NCT02522767 Completed - Ulcerative Colitis Clinical Trials

Mesalamine 4 g Sachet for the Induction of Remission in Active, Mild to Moderate Ulcerative Colitis (UC)

Start date: October 2015
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to investigate the efficacy of mesalamine for the induction of clinical and endoscopic remission in subjects with active, mild to moderate UC. Subject will receive 4 g extended release granules (sachet) once daily.

NCT ID: NCT02519621 Completed - Ulcer Clinical Trials

NPWT PRO vs KCI Ulta® NPWT and to Compare NPWT PRO vs NPWT PRO With Simultaneous Irrigation on Wound Healing

Start date: April 2016
Phase: N/A
Study type: Interventional

This study is designed to assess the efficacy and economics of two NPWT (negative pressure wound therapy) branded devices of wound healing outcomes. It is also designed to assess the effectiveness of negative pressure and negative pressure with continuous irrigation on multiple parameters of wound healing. It is a single-center, open-label, active controlled, parallel-group trial that aims to determine the efficacy of Quantum with simultaneous irrigation in the treatment of diabetic foot ulcers. Specifically, eligible participants will be randomized to receive either PRO negative press therapy with simultaneous irrigation; or PRO negative pressure therapy without irrigation; or KCI Ulta negative pressure therapy. Outcomes will include rates of wound healing, time to closure, number of surgeries, length of stay, and days to heal.

NCT ID: NCT02516384 Completed - Ulcerative Colitis Clinical Trials

Fecal Microbiota Transplantation (FMT) in the Management of Ulcerative Colitis (UC)

Start date: October 1, 2016
Phase: Phase 1
Study type: Interventional

Inflammatory bowel disease is a condition caused by gastrointestinal immune system dysregulation and affected by both genetic and environmental factors. Differences in intestinal bacteria exist between IBD patients and healthy controls, but the role of intestinal bacteria in the development and treatment of IBD remains largely unknown. Fecal microbiota transplantation (FMT) is the transfer of gastrointestinal bacteria from a healthy donor to a patient with altered microbial diversity with the intent of restoring a normal bacterial balance. Most studies focus on its use in treating Clostridium difficile (CDI), an infection characterized by dysbiosis. Given the role of dysbiosis in IBD, the investigators hypothesize that FMT may be beneficial in IBD. The purpose of this study is to prospectively examine the safety of FMT in the management of ulcerative colitis (UC).

NCT ID: NCT02512159 Completed - Foot Ulcer Clinical Trials

Skin Ulcers Treatment With an Handicraft Topical Device

Start date: March 2014
Phase: Phase 4
Study type: Interventional

The aim of this study was to evaluate the efficacy of a handicraft topical device of negative pressure versus traditional healing treatment for skin ulcers in lower limbs; in patients with diabetes mellitus, venous stasis and arterial insufficiency.

NCT ID: NCT02508012 Completed - Ulcerative Colitis Clinical Trials

Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases

ATAIM
Start date: September 24, 2015
Phase: N/A
Study type: Interventional

Since their appearance more than a decade ago, anti-tumor necrosis factor (TNF) inhibitors have demonstrated beneficial activity in the treatment of inflammatory bowel diseases (IBD). However, more than one-third of patients present primary resistance, and one more third become resistant over time. One of the main factors associated with loss of response is the immunogenicity of anti-TNF biologics leading to the production of antibodies targetting the TNF inhibitor, namely anti-drug antibodies (ADAbs), that accelerate drug elimination from the serum and decrease its therapeutic activity. In this study the investigators propose a medico-economic evaluation of the measurement of anti-TNF agents and anti-drug antibodies serum concentrations in the management of patients with inflammatory bowel disease treated with anti-TNFalpha inhibitors. 280 patients with Crohn's disease (CD) or ulcerative colitis (UC) will be included and randomized in 2 groups with or without drug and ADAbs monitoring. In the monitored group, in case of loss of response, the clinician will use biological informations to adapt the treatment following a simple treatment algorithm. In the unmonitored group, drug and ADAbs measurements will not be transmitted to the clinician. Clinical and economical benefits of the biological monitoring will be evaluated after a follow-up period of two years.

NCT ID: NCT02506179 Completed - Ulcerative Colitis Clinical Trials

Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis

UCanADA
Start date: August 18, 2015
Phase:
Study type: Observational

To evaluate the real-life effect after 1 year of adalimumab treatment on psychological distress/depression symptoms in moderate-to-severe Ulcerative Colitis (UC) patients.

NCT ID: NCT02501538 Completed - Clinical trials for Foot Ulcer, Diabetic

Continuous Diffusion of Oxygen (CDO) Treatment for Healing of Diabetic Foot Ulcers

EO2
Start date: June 2015
Phase: N/A
Study type: Interventional

This is a pilot study. Maximum 30 subjects with a diabetic foot ulcer (DFU) or surgical foot wound will be consented in order to have 20 eligible subjects who will be enrolled and completed the study. Study duration will be three weeks. Patients will be consented and undergo debridement as standard of care at day 0. Ankle-Brachial Index (ABI), Monofilament Sensory Test and Vibration Perception Threshold(VPT) test will be performed only at day 0. Tissue samples will be taken at this visit during standard of care wound debridement and these tissue samples of the wound would normally be removed as part of routine debridement. These tissue samples of the wound will be used for gene expression and bacterial analysis(research). The patient will then receive topical oxygen therapy using the Transcutaneous O2 device (research) with moist wound dressings for 21 days. Moist wound dressings are used as standard of care. Treatment will be initiated during Screening/Baseline visit(day 0) after routine wound debridement, and patient will receive instructions for home use of the device. The patient will be seen for routine wound debridement at days 7, 14, and 21 with a study window of 5 days., Digital photos of the wound, and vascular evaluations (Transcutaneous oxygen measurements and Hyperspectral imaging. will be performed at each study visit(research). Tissue samples will be taken during standard of care wound debridement at every study visit. Results of the data analysis from this project will be used to inform the design of a larger randomized clinical trial.

NCT ID: NCT02499263 Completed - Ulcerative Colitis Clinical Trials

A Prospective Non-interventional Multicenter Study to Evaluate the Effectiveness of Adalimumab in Korean Patients With Ulcerative Colitis (UC) and Identify Potential Predictors of Clinical Response in Routine Clinical Practice

EUREKA
Start date: June 11, 2015
Phase:
Study type: Observational

This is a prospective, single country, multi-center study in participants with ulcerative colitis (UC) treated with adalimumab. Up to 147 participants are enrolled at approximately 20 sites. The baseline assessment is performed prior to the first dose of adalimumab (Visit 1). Study visits are conducted at weeks 8, 16, 24, 32, 40, 48 and 56 after baseline in accordance with clinical practice. All participants will have one Follow-up for safety approximately 70 days after the last dose of adalimumab.