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Ulcer clinical trials

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NCT ID: NCT02129439 Completed - Colitis, Ulcerative Clinical Trials

Efficacy, Pharmacokinetics, Tolerability, Safety of SB012 Intrarectally Applied in Active Ulcerative Colitis Patients

SECURE
Start date: April 2014
Phase: Phase 1/Phase 2
Study type: Interventional

Ulcerative colitis (UC) represents one of the major entities of idiopathic inflammatory bowel diseases which are defined as chronically relapsing inflammations of the gastrointestinal tract not due to specific pathogens. It is characterised by a superficial, continuous mucosal inflammation, which predominantly affects the large intestine. The clinical course is typically marked by periods of asymptomatic remission punctuated by unpredictable recurrent attacks. The symptoms of the patients are marked by persistent diarrhoea with severe faecal urgency and often incontinence, rectal bleeding, abdominal cramping and weight loss. Uncontrolled activation of mucosal effector T cells has been identified as the main pathogenic mechanism involved in the initiation and perpetuation of intestinal inflammatory reactions. Patients with moderate UC are initially treated with mesalazine, applied both orally and rectally. If symptoms do not improve, systemic corticosteroids are to be administered. Patients who do not respond to systemic corticosteroids may become eligible for treatment with a calcineurin inhibitor or an anti-tumor necrosis factor (TNF)α antibody. Alternatively, patients may have to undergo major colorectal surgery. Patients who do not adequately respond to these treatment strategies exhibit serious drawbacks. Colorectal surgery may result in a severely compromised quality of life. Therefore, patients with moderate or severe UC may significantly benefit from new therapeutic alternatives. The transcription factor GATA-3 is an interesting target for a novel therapeutic strategy in UC. GATA-3 is the key regulation factor of Th2-driven immune responses. It is indispensable for the differentiation and activation of Th2 cells, integrates Th2 signals, and induces Th2 cytokine expression. Results of a recent clinical trial in children showed that GATA-3 is involved in the pathogenesis of the acute phase of UC. The investigational product SB012 contains the DNAzyme hgd40 that targets GATA-3. By cleaving GATA-3 mRNA hgd40 reduces specific cytokine production and thereby reduces key features of mucosal inflammation. DNAzymes are completely generated by chemical synthesis, not by use of any living organism and are therefore not biological drugs. This study will evaluate the efficacy, safety, tolerability and pharmacokinetics of the topical formulation SB012 available in a concentration of 7.5mg/ml hgd40 in 30ml PBS once daily as a ready-for-use enema in patients with active UC.

NCT ID: NCT02120391 Completed - Ulcerative Colitis Clinical Trials

Improving Knowledge of Medication in Ulcerative Colitis With an Iphone Application

Start date: February 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to assess an iPhone application to increase adherence to maintenance medications in subjects with ulcerative colitis.

NCT ID: NCT02119754 Completed - Infection Clinical Trials

Topical PluroGel PN for the Treatment of Mildly Infected Diabetic Foot Ulcers

Start date: October 2013
Phase: Phase 2
Study type: Interventional

This is an open label study of subjects who have failed Protocol PGN-1300. Adult subjects (greater than 18 years old) who present with a mildly infected diabetic foot ulcer (IDSA criteria) having full thickness (i.e., through the dermis but not involving joint capsule, tendon, and bone) and have failed PGN-1300. Subjects must also provide informed consent and meet all other entry criteria to be enrolled and receive PluroGel PN.

NCT ID: NCT02111291 Completed - Clinical trials for Diabetic Foot Ulcers

Santyl Applications to Diabetic Foot Ulcers

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

The current trial examines the potential benefits of continuous 12 week treatment with Santyl, measured in terms of wound bed appearance. The visual appearance of granulation tissue will be recorded at each visit for the purpose of examining the relationship between wound bed appearance and progress towards healing. In support of this longer treatment regimen with Santyl, a recent animal study found that application of Santyl for 12 weeks was safe and well tolerated. Therefore, the present study is designed to test the hypothesis that daily treatment of diabetic foot ulcers (DFU) with Santyl for up to 12 weeks will result in more rapid development of granulation tissue than DFU treated with supportive care.

NCT ID: NCT02110862 Completed - Ulcerative Colitis Clinical Trials

Scintigraphic Evaluation of IPAA Function in Patients With Ulcerative Colitis

SKIPO
Start date: January 2012
Phase: N/A
Study type: Observational

The aim of this study is to evaluate scintigraphic methods as objective factors for functional outcome in patients treated with ileal-pouch-anal anastomosis (IPAA). The gastrointestinal transit-time and the degree of evacuation are evaluated in relation to the functional outcome.

NCT ID: NCT02108821 Completed - Clinical trials for Ulcerative Colitis (UC)

Fecal Microbiota Transplantation in Pediatric Patients

FMT
Start date: March 2014
Phase: Phase 1
Study type: Interventional

A disturbance in the diversity of gut bacterial composition could be linked to several immune mediated diseases including inflammatory bowel diseases (IBD). IBD can be classified into Crohn's Disease (CD) and Ulcerative Colitis (UC). Both these diseases occur from abnormal immune reaction to resident gut bacteria.The process of fecal microbiota transplantation (FMT) where fecal bacteria from a healthy individual is transferred into a recipient, has recently received attention as an alternative therapy for individuals affected with these life-altering diseases. In this study, the investigators will perform fecal transplantation on the subjects meeting inclusion criteria, to determine the efficacy and safety of this therapy in subjects with IBD (CD and UC) who are not responding to first line therapy, and are in a flare.

NCT ID: NCT02104180 Completed - Venous Leg Ulcer Clinical Trials

Evaluation of Pain Associated With the Removal of Wound Dressing During Care of Venous Leg Ulcer. Comparison of the Efficacy and Safety of Two Dressings Urgotul and TulleGras

Start date: February 2014
Phase: N/A
Study type: Interventional

Evaluation of the non-inferiority of TulleGras M.S.® versus Urgotul® in pain associated with removal of wound dressing during care of venous leg ulcer

NCT ID: NCT02101645 Completed - Clinical trials for Patients With Lower Extremity Venous Ulcers

Proof-of-concept Study for Bioimpedance Based Monitoring of Venous Ulcers During Galvanic Stimulation

Start date: March 2014
Phase: N/A
Study type: Interventional

The research group will choose no more than 10 patients having a lower extremity venous ulcer(s), less than 5cm diameter and with an estimated one month time of re-epithelization. In this study the investigators will follow and monitor the healing of the wound and effectiveness of compression therapy using bioimpedance measurement based method. The investigators will also treat the wounds using periodical low intensity direct current (LIDC) stimulation therapy. Bioimpedance monitoring and wound stimulation functionalities are provided by a purpose built wound patch. The patch features a printed 4 x 4 stimulation and impedance measurement electrodes array (in contact with wound surface) surrounded by a 4-part dual purpose counter and impedance reference electrodes (in contact with the intact skin surrounding the wound area).

NCT ID: NCT02100696 Completed - Ulcerative Colitis Clinical Trials

A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors

HICKORY
Start date: May 21, 2014
Phase: Phase 3
Study type: Interventional

This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with moderately to severely active ulcerative colitis (UC) who have been previously exposed to TNF inhibitors.

NCT ID: NCT02099708 Completed - Clinical trials for Gastric or Duodenal Ulcers

Long-term Use of Takepron on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs

Start date: October 2010
Phase: N/A
Study type: Observational

The purpose of this study is to investigate the safety and efficacy of long-term administration of lansoprazole (Takepron) therapy for up to 12 months in the routine clinical setting in patients receiving oral non-steroidal anti-inflammatory drugs (NSAIDs)