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Ulcer clinical trials

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NCT ID: NCT02423187 Completed - Gastric Ulcer Clinical Trials

Rabeprazole Specific Clinical Experience Investigation for the Long-term Combination Therapy With Low-dose Aspirin

Start date: March 17, 2015
Phase:
Study type: Observational

To investigate the safety and efficacy of long-term combination therapy with rabeprazole and low-dose aspirin.

NCT ID: NCT02422017 Completed - Venous Leg Ulcers Clinical Trials

Topical Timolol Benefit in Venous Ulcers

EETUV
Start date: April 2015
Phase: Phase 2
Study type: Interventional

Background: Venous Leg ulcers are a frequent pathology in dermatology and complex in their management. At the origin of high health costs and strong repercussions on quality of life for patients, they require long management and may be subject to possible complications. In spite of appropriate treatment, 50-60% of these ulcers are not healed at 24 weeks. Purpose: Topical beta adrenergic antagonists have shown efficacy in wound healing. The purpose of this study is to evaluate the efficacy and safety of treatment of chronic venous ulcers with topical timolol.

NCT ID: NCT02421705 Recruiting - Healthy Controls Clinical Trials

Visceral Sensitivity in IBD (Irritable Bowel Disease) and IBS (Irritable Bowel Syndrome)

Start date: February 2010
Phase: N/A
Study type: Interventional

Aim: More insight in pathogenesis of IBS and IBD. Samples are collected in context of an European research project.

NCT ID: NCT02418676 Completed - Pressure Ulcer Clinical Trials

Insulin Complexation With Hydroxypropyl-beta-cyclodextrin: Use of the Complex in Gel for Healing of Pressure Ulcers

Start date: March 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The coprecipitation method was used to prepare hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) by mixing insulin with hydroxypropyl-beta-cyclodextrin (HPβCD) in the molar ratio of 1:5 with the addition of 10 mL of purified water for every 100 mg of the complex. After complete dissolution of the material, the mixture was stirred for 30 min at room temperature (25°C), then left to rest for 60 min and lyophilized. The gel was prepared by dispersing the Carbopol 940® polymer in a known amount of purified water. Under mild heating the methylparaben (0.02%, w/v), propylparaben (0.01%, w/v) and propylene glycol were dissolved and incorporated in the dispersion of Carbopol 940® and left to rest for a period of 12h. After this time, the prepared gel was stirred and pH corrected to a range of 5.0 to 7.0 with triethanolamine. A set amount of insulin and the HPβCD-I complex were incorporated into the control gel for the preparation of other formulations. A randomized, double-blind, prospective clinical trial was conducted from March 2013 to April 2014 at the Hospital Universitário Regional de Maringá (HUM), Paraná, Brazil, in order to determine the safety and efficacy of gel in patients hospitalized in the Intensive Care Unit. Hyperglycemic volunteers and those with pressure ulcers other than grade II were excluded from the study. Grade II pressure ulcers were selected as they are a superficial lesion, with little tissue loss, and allow easy visualization of healing. A letter of free and informed consent was obtained. The study was conducted with each patient for a period of 15 days. The volunteers were divided equally into three groups A, B and C, with each group being formed by five volunteers (n=5). Group A was randomly selected for treatment with gel with HPβCD-I complex, group B for treatment with gel with insulin, and group C with the control gel. Blood glucose tests were performed in order to assess whether the insulin complexed or otherwise with HPβCD could cause an increase in the rate of insulin in the blood in patients, leading to hypoglycemia. An identical standardized procedure for gel placement was used for all patients. Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film. The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation. At the end of this stage, the properly gathered study data was interpreted using the analysis software Mobile Wound Analyzer® (MOWA). Data was evaluated by variance analysis (ANOVA), and means were compared with the Tukey test (p < 0.05) using the software Statistica 8.0/2008 (Stat Soft Inc., Tulsa, USA). Mixed model repeated measures methodology with some covariance structures was adopted for statistical analysis of the clinical trial (p < 0.05). The Statistical Analysis System (SAS) for Windows, version 9.3 (SAS Inc., Chicago, IL) program was used for statistical analysis.

NCT ID: NCT02418312 Completed - Peptic Ulcer Clinical Trials

Efficacy of H2 Receptor Antagonist in Prevention of Thienopyridine-related Peptic Ulcer

Start date: January 2012
Phase: N/A
Study type: Interventional

Whether H2 receptor antagonist can prevent thienopyridine-related peptic ulcer remains unclear.

NCT ID: NCT02412085 Recruiting - Colitis, Ulcerative Clinical Trials

Golimumab in Steroid-dependent Ulcerative Colitis: Induction and Maintenance of Clinical and Endoscopic Remission

UC-GOL
Start date: March 2015
Phase: Phase 4
Study type: Interventional

This is an open-label, phase IV trial. Adult patients, with moderately to severe, steroid dependent, acute ulcerative colitis not previously exposed to anti-TNF, will receive subcutaneous golimumab treatment, according to EU marketing authorization from baseline through week 14. At week 16, patients achieving clinical and endoscopic remission will continue with Golimumab, 50 mg or 100 mg (depending on body weight) every 4 weeks, through week 52. Patients not achieving clinical and endoscopic remission will be treated with infliximab, according to marketing authorization, and followed through week 52. This is not considered as an interventional arm but, since infliximab in Italy is considered as the first-line treatment for UC patients, as the usual clinical practice.

NCT ID: NCT02407236 Completed - Clinical trials for Inflammatory Bowel Diseases

A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis

UNIFI
Start date: July 10, 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of ustekinumab as intravenous (IV: into the vein) infusion in induction study in participants with moderately to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration in maintenance study in participants with moderately to severely active Ulcerative Colitis (UC) who have demonstrated a clinical response to Induction treatment with IV ustekinumab.

NCT ID: NCT02405767 Completed - Diabetic Foot Ulcer Clinical Trials

BioimPEDance of Diabetic Foot Ulcers

BIPPED
Start date: April 2015
Phase: N/A
Study type: Interventional

The BIPPED study seeks to determine whether wound healing, in particular diabetic foot ulcers, can be monitored using electrical bioimpedance analysis (BIA). BIA measures the resistance of biological tissue to the passage of a very small electric current applied with electrodes. Different types of tissue, due to cell structure, hydration and vascularization, have specific electrical characteristics. The BIPPED study aims to provide experimental data for the development of a BIA sensor for monitoring of wound healing in chronic wounds.

NCT ID: NCT02402374 Enrolling by invitation - Clinical trials for Diabetic Foot Ulcers

Evaluate the Safety and Efficacy of RegenKit Autologous PRP Gel for the Treatment of Diabetic Foot Ulcer

Start date: April 12, 2018
Phase: N/A
Study type: Interventional

Autologous platelet-rich plasma (PRP) gel was reported to have very good outcomes in the treatment of foot ulcers in pilot studies and retrospective uncontrolled trials. Therefore, a larger randomized, placebo-controlled clinical trial will be useful to determine whether platelet-rich plasma is safe and effective for the treatment of diabetic foot ulcers (DFU).

NCT ID: NCT02399826 Recruiting - Diabetic Foot Clinical Trials

Study of Amniotic Membrane Graft in the Management of Diabetic Foot Ulcers

Start date: March 2015
Phase: N/A
Study type: Interventional

This is comparison trial comparing human amniotic membrane to standard wound care for non healing diabetic foot wounds over a 12 weeks period