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Ulcer clinical trials

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NCT ID: NCT02506452 Active, not recruiting - Clinical trials for Diabetic Foot Ulcers

Postmarket Study to Evaluate Biovance® in Diabetic Foot Ulcers

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

The purpose of this study is to compare the wound closure outcomes of subjects receiving diabetic foot ulcer treatment with and without the use of Biovance®.

NCT ID: NCT02390726 Active, not recruiting - Clinical trials for Ulcerative Colitis, Active Moderate

Fecal Microbiota Transplant in the Treatment of Ulcerative Colitis

FMTUC
Start date: December 2015
Phase: Early Phase 1
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of Fecal Microbiota Transplant (FMT) for treating patients with mild to moderate Ulcerative Colitis (UC). Even with the expanding choices of medication for UC, physicians and patients are still in search of highly effective and safe medications with minimal side effects. FMT has been approved for the treatment of a bacterial infection called Clostridium difficile. In this setting, FMT has been proven to be an effective and safe alternative therapy with zero reported serious adverse events from patients that have had this treatment. The providers that are conducting this study hypothesize that delivering microbes from a healthy human gut can help treat the damages caused by UC. This is done by "transplanting" fecal material, which contains a highly complex and dense community of healthy microbes, including bacteria, fungi and viruses. This collection of microbes is referred to as a microbiome. Preliminary studies suggest that alteration of the microbiome can help treat UC.

NCT ID: NCT02380820 Active, not recruiting - Pressure Ulcer Clinical Trials

Comparative Measurements of Interface Pressures Between Two Pressure-ulcer Prevention Mattresses: Softform Premier and Airsoft Duo

SPA2-INVACARE
Start date: June 2015
Phase: N/A
Study type: Interventional

The main objective of this study is to compare the Softform Premier mattress (in static mode) and AIRSOFT DUO mattresses in terms of skin pressures measured at the sacral area.

NCT ID: NCT02344329 Active, not recruiting - Diabetes Clinical Trials

A Comparison of TCC-EZ Using Human Amnion Allograft vs TCC-EZ and Standard Wound Care in Treating Diabetic Foot Ulcers.

TAD
Start date: August 2014
Phase: Phase 4
Study type: Interventional

A Comparison of AmnioExcel® and Total Contact Casting (TCC-EZ) Versus Standard Wound Care and TCC-EZ in Treating Diabetic Foot Ulcers Best practice is to treat DFUs with standardized care and, if unsuccessful, use advanced modalities. This prospective clinical trial will compare healing rates between two treatment modalities in patients with DFUs in an ambulatory wound care clinic. The treatments are Total Contact Cast (TCC-EZ) with AmnioExcel® and TCC-EZ with standard treatment. Adult participants 18 years or older with a diabetic foot ulcer located on the plantar surface and >1 cm in diameter will be asked by the Altru Wound Care Clinic MD or Family Nurse Practitioner visit to participate in the study if they have not demonstrated a 50% in reduction in wound area after two weeks of standard treatment. For those potential subjects who do not have 3rd party reimbursement the cost of the product and application will be covered by the respective company. They must be cognitively intact as evaluated by wound clinic primary care providers. Participants must agree to use the study treatments as directed, and to keep clinic visits during the 12-week trial or until the ulcer closes, whichever comes first.

NCT ID: NCT02326337 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Efficacy, Safety and Economic Benefits of Topical Wound Oxygen Therapy in the Treatment of Chronic Diabetic Foot Ulcers

TWO2DFU
Start date: October 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety and economical benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of chronic diabetic foot ulcers. Subjects will wear a standardized off-loading device and use advanced moist wound therapy (AMWT) dressings. Following a 2 week run-in period with the standardized care and after meeting all the eligibility criteria, half the subjects will use the TWO2 device, while the other half will use a sham device.

NCT ID: NCT02291523 Active, not recruiting - Ulcerative Colitis Clinical Trials

The Effect of Therapeutic Fecal Transplant on the Gut Microbiome in Children With Ulcerative Colitis

FMT_UC
Start date: November 1, 2016
Phase: Phase 1
Study type: Interventional

Ninety Six patients with mild to moderate ulcerative colitis will be randomized to double blind, placebo controlled study. The safety and efficacy of the intervention will be closely monitored.

NCT ID: NCT02157376 Active, not recruiting - Clinical trials for Stress Ulcer Prophylaxis

Stress Ulcer Prophylaxis of Intravenous Esomeprazole in Chinese Seriously Ill Patients

SUP
Start date: July 2014
Phase: Phase 3
Study type: Interventional

The efficacy of esomeprazole will be compared versus cimetidine (a drug that previously demonstrated prevention of bleeding events) during treatment period in proportion of patients for the prevention of upper GI bleeding.

NCT ID: NCT02153034 Active, not recruiting - Buruli Ulcer Clinical Trials

Pathogenesis and Management of M. Ulcerans Disease, Buruli Ulcer

Buruli_Path
Start date: May 2013
Phase: N/A
Study type: Observational

Buruli ulcer is a neglected tropical disease caused by infection with Mycobacterium ulcerans (Mu) in rural parts of West Africa. It causes large skin ulcers mainly in children aged 5 to 15 years. Access to treatment is limited and many cases present late. There have been major advances in understanding the mechanism of disease together with improved diagnosis and management. The aim of the proposed studies is to identify markers predictive of a rapid response to antibiotic treatment and to investigate the pathogenesis of paradoxical reactions and oedematous lesions in Mu disease. Infection with Mu results in a nodule under the skin which enlarges and breaks down to form an ulcer. This is because Mu produces a toxin that spreads outwards and damages subcutaneous tissue. In recent years it has been found that antibiotic treatment for 8 weeks with daily tablets and intramuscular injections heals ulcers. This is unpleasant and it would be better if the treatment could be shortened. Our previous studies suggest this may be possible. Therefore a wide range of tests will be investigated in order to identify markers for people in whom the infection is at an early stage with low numbers of Mu bacteria and low levels of toxin in the skin. During antibiotic treatment the rate of healing will be measured to find out which markers are the most reliable. In some patients new areas of inflammation develop despite treatment and this is called a paradoxical reaction. The immune response to Mu will be investigated serially during antibiotic treatment to investigate the cause of paradoxical reactions. About 15% of patients have oedematous disease, the most severe form of Buruli ulcer. We will study the amount of Mu toxin produced by the strain of Mu cultured from patients with this form of the disease. Hypothesis - Buruli ulcer patients that heal rapidly/slowly or develop paradoxical reactions with treatment will have associated predictive viability or serum biomarkers. - Buruli ulcer patients with oedematous disease are associated with larger amounts of mycolactone and viable organisms

NCT ID: NCT02130310 Active, not recruiting - Clinical trials for Chronic Venous Leg Ulcers

Evaluation of CureXcell® in Treating Chronic Venous Leg Ulcers

Start date: May 2014
Phase: Phase 3
Study type: Interventional

The primary objective is to evaluate the clinical benefit of CureXcell® as adjunct to Standard of Care in the treatment of Chronic Venous Leg Ulcers. CureXcell® is a cell based therapy, containing activated homologous white blood cells prepared from donated healthy whole blood. A total of 252 patients will be randomized to receive either CureXcell® or Placebo.

NCT ID: NCT02084550 Active, not recruiting - Ulcerative Colitis Clinical Trials

Amino Acids in Ileal Pouch-anal Anastomosis for Ulcerative Colitis

AMINOPOUCH
Start date: September 2015
Phase: N/A
Study type: Interventional

The detrimental effects of catabolism, insuline resistance and muscle wasting on surgical outcome is wellknown. This catabolism is especially pronounced in patients with acute or chronic inflammation (IBD, cancer) and for those undergoing major surgery. Patients with ulcerative colitis operated with an ileal pouch-anal anastomosis (j-pouch) fall well into both these categories. To prevent this undesirable catabolism, we will investigate the effects of intravenous administration of predominantly anabolic amino acids (with an amino acid content equal to breast milk) on whole body metabolism, with special emphasis on muscle and fat metabolism and intracellular signalling pathways. Twenty-four patients will be block-randomized by gender in this parallel-group, randomized, assessor-blinded, placebo-controlled trial to receive either Vaminolac® (Fresenius Kabi) or saline. Metabolism before and after the intervention will be assessed by palmitate- and amino acid kinetics of radioactively labelled tracers, while muscle and fat biopsies will be analyzed for differences in intracellular signaling pathways (PI3 kinase, Akt, etc.) as a measure of cellular activity. With this study we hope to find evidence for anabolic effects of intravenous amino acids in j-pouch surgery for ulcerative colitis. The perspective is a potential for primary prophylaxis of surgical complications, reduction in the length of hospitalization, and subsequently optimized long-term functional outcome of the pouch.