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Ulcer clinical trials

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NCT ID: NCT00825760 Completed - Wound Healing Clinical Trials

Clinical Trial to Investigate Treatment With Photodynamic Therapy to Reduce Levels of Bacteria in Leg Ulcers

Start date: January 2009
Phase: Phase 2
Study type: Interventional

Some leg ulcers do not seem to respond that well to the standard treatments that we currently use. One reason for this may be that there are high levels of bacteria in the ulcer which may be slowing down the rate of healing. Because we need to be careful about when we use antibiotics, this study will look at another way of killing bacteria in the ulcer. This new method involves putting a special gel on the ulcer and then shining a particular type of light (visible red light) onto the ulcer for a short period of time. In the first part of the study, a single treatment with the gel and light will be investigated. The second part of the study will compare whether or not using the treatment once a week for 12 weeks is better than placebo. Across the UK 57 people with chronic leg ulcers will be asked to take part in this study (9 in part 1 and 48 in part 2). Up to 10 sites will be involved including Cardiff University and hospitals in Bradford, Harrogate, Dundee, Hull, Plymouth and the Wirral. The research is funded by Photopharmica Ltd.

NCT ID: NCT00823446 Completed - Clinical trials for Venous Stasis Ulcers

Feasibility Study to Evaluate the Safety of Topically Applied Revera in Subjects With Venous Leg Ulcers

Start date: March 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to perform a preliminary evaluation of the safety of Revera Wound Care when topically applied to venous leg ulcers for 8 weeks of treatment.

NCT ID: NCT00820196 Completed - Venous Ulcer Clinical Trials

A Trial to Assess the Safety and Activity of Nexagon® for the Treatment of Venous Leg Ulcers (The NOVEL Study)

Start date: March 2009
Phase: Phase 2
Study type: Interventional

Venous leg ulcers are a common, costly and debilitating condition, with few effective treatments. Compression bandaging helps healing, but more than four out of every ten leg ulcers remain unhealed after three months. New treatments to help heal venous ulcers are urgently needed. Initial studies with a new drug product candidate called Nexagon® (developed by CoDa Therapeutics, Inc.) have shown improvements in healing when applied topically to a wound. Further research will be undertaken to assess the safety and activity of Nexagon® when applied to venous leg ulcers in humans, and to obtain further information on the most appropriate dose or doses to apply. A proposed randomised controlled trial aims to further evaluate Nexagon® by randomly allocating (e.g., by the toss of a coin) 90 people with venous leg ulcers to Nexagon® (one of two different doses) or a vehicle (substance containing no medication) to be applied to their ulcer three times over four weeks. Participants will be followed up for 12 weeks to evaluate ulcer healing.

NCT ID: NCT00816491 Completed - Ulcerative Colitis Clinical Trials

Comparison Between Chromoendoscopy and Conventional Colonoscopy to Improve the Detection of Neoplasia in Patients With Ulcerative Colitis (UC)

Start date: October 2008
Phase: N/A
Study type: Interventional

The primary endpoint of the study will be to compare the accuracy of two procedures (FICE with target biopsies only, versus conventional white light colonoscopy with recommended targeted and random biopsies) in the endoscopic surveillance of patient with long-standing UC. Accuracy will be measured based on the number of patients with confirmed neoplasia using each technique. The combined histological outcome following the two procedures will represent the gold-standard diagnosis for each patient. Secondary outcomes will be the number of patients with false-positive findings, the number of neoplastic lesions detected, the number of false-positive lesions per patient for each technique and the total time required for each procedure.

NCT ID: NCT00808977 Completed - Ulcerative Colitis Clinical Trials

A Phase II Study to Explore the Safety and Activity of Dersalazine in Patients With Mild to Moderate Ulcerative Colitis

Start date: December 2008
Phase: Phase 2
Study type: Interventional

The purpose of the study is to obtain a first clinical assessment of the safety of dersalazine sodium in ulcerative colitis patients with mild to moderate disease.

NCT ID: NCT00807664 Completed - Leg Ulcers Clinical Trials

Biatain Ag vs Biatain in the Treament of Leg Ulcers

Start date: December 2008
Phase: N/A
Study type: Interventional

the objective of this investigation is to demonstrate the effect of the foam dressing Biatain Ag, compared to Biatain foam dressing( a product which is similar but does not contain a silver complex, in the healing of leg ulcers that had failed to heal despite appropriate therapy

NCT ID: NCT00804414 Completed - Diabetes Clinical Trials

Efficacy and Safety Study of Soluble Beta-1,3/1,6-glucan (SBG) Versus Placebo in Chronic Diabetic Foot Ulcers

Start date: October 2008
Phase: Phase 3
Study type: Interventional

Evaluation of efficacy and safety of SBG vs placebo in the treatment of chronic diabetic foot ulcers.

NCT ID: NCT00803829 Completed - Ulcerative Colitis Clinical Trials

Synbiotic Treatment of Ulcerative Colitis Patients

Start date: January 2009
Phase: N/A
Study type: Interventional

Ulcerative colitis (UC) is one of the two main forms of inflammatory bowel disease. UC is associated with high morbidity and incurs significant social, commercial and NHS costs. For a variety of reasons, many patients are refractile to standard therapies, which often have undesirable side-effects. However, an inexpensive and non-toxic treatment based on the synbiotic concept may prove to be effective in these individuals. A synbiotic is a mixture of a probiotic (a live microorganism) and a prebiotic, which is a carbohydrate that serves as a food source for the probiotic, allowing it to grow better in the gut. The aim of this study is to determine whether a synbiotic comprised of fructooligosaccharides and inulin, together with a bifidobacterial probiotic (Bifidobacterium longum), that we have previously shown to reduce inflammatory processes in the gut wall (mucosa) in a short-term pilot trial, can colonise the bowel, reduce mucosal inflammation, and induce remission in UC patients with active disease. It is planned to establish a double-blinded, controlled, randomised investigation involving 46 patients for six months. If the results from our pilot study can be reproduced and maintained in a long-term investigation, the synbiotic could become available very quickly, and would provide an inexpensive and effective treatment for UC, making a significant contribution to relieving the clinical and financial burdens of this disease.

NCT ID: NCT00801723 Completed - Ulcerative Colitis Clinical Trials

(CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.

Start date: December 2008
Phase: Phase 3
Study type: Interventional

Randomized, double-blind, comparative study versus placebo performed in patients from studies CB-01-02/01 (NCT00679432), CB-01-02/02 (NCT00679380), or CB-01-02/06 (NCT01100112) who achieved ulcerative colitis disease activity index (UCDAI) remission after 8 weeks of treatment. Patients in remission at the End of Study visit will be given the opportunity to enter the 12-month Maintenance Phase study outlined in this protocol (CB-01-02/04). The End of Study visit in studies 01, 02, and 06 will be set as the Visit 1 (Day 0) of this study. There will be no interruption of study treatment between the parent studies and this study. It is planned that approximately 150 patients will be enrolled in the study. Patients will be randomly assigned to two groups to receive either budesonide MMX 6 mg or placebo irrespective of the treatment assigned in studies 01, 02, or 06. Treatments will be administered once a day after breakfast for a maximum of 12 months or up to the occurrence of the first clinical relapse, where clinical relapse is defined as combined recurrence of rectal bleeding and stool frequency ≥ 1-2 stools/day above normal for the patient (score ≥ 1 in both UCDAI items). During the study, patients will be assessed for safety and efficacy at Visit 1 and after 1, 3, 6, 9, and 12 months of treatment. Patients will be contacted by telephone on a monthly basis for safety assessment. In case of occurrence of symptoms suggestive of clinical relapse, patients will attend an unscheduled visit at any time during the study.

NCT ID: NCT00798642 Completed - Ulcerative Colitis Clinical Trials

Ulcerative Colitis Relapse Prevention Trial, Hypnosis

UCRPT
Start date: July 2007
Phase: N/A
Study type: Interventional

The UCRPT is a randomized controlled trial to determine if a type of hypnotherapy will maintain remission in patients affected by Ulcerative Colitis.