Active clinical trials for "Ulcer"

The purpose of this study is to assess the clinical benefit and tolerability of adalimumab, a fully human monoclonal antibody to tumor necrosis factor α (TNF- α), in patients with ulcerative colitis (UC) naive to treatment with biologics.

The purpose of this study is to determine safety and efficacy of a new gel formulation of Esmolol hydrochloride (Galnobax®) for the treatment of Diabetic Foot Ulcer (DFU). The study will compare number and types of adverse events occured, rates of wound closure and percentage of wounds closed in Galnobax treated groups versus placebo group.

It is estimated that 300 million people worldwide will have diabetes by the year 2025. About 12 percent of those with diabetes will have had a foot ulcer, which is a major source of morbidity, concern, and cost. The foot ulcers are the leading cause of hospitalization among people with diabetes and often lead to amputation. The costs of treatment and the high morbidity and mortality associated with diabetic foot problems necessitate the need for a systemic approach to a foot ulcer management. Current local treatments of this type of ulcer are: dressings (hydrocolloids, alginate…), and growth factors. However modern dressings may not avoid infection and the results of the clinical studies are not significant in terms of complete healing rate or in terms of time to healing. Concerning growth factors, the only one whose therapeutic application made proof is the rhPDGF (Regranex®) with an increase in the number of ulcers completely healed at the twentieth week compared to placebo (50% and 35%, respectively). The advancement of tissue-engineering has made possible dermal replacement on human wounds to facilitate healing. A new sponge composed of collagen and glycosaminoglycans (chondroitins 4 and 6 sulphate), reticulated by ionic bonds with chitosan before freeze-drying, was developed in France. This sponge is a non-toxic product due to its non-chemical reticulation (ionic bonds), biocompatible and biodegradable processes, handling and storable easily. The objective of this study is to demonstrate that such a substitute, cellularized by functional allogenic fibroblasts, and complying with all safety conditions, enables to lead to healing of diabetic foot ulcers.

A prospective, double blind, randomized, placebo controlled, outpatient, parallel group comparison trial to assess the safety and efficacy of HO/03/03 10µg versus Placebo, applied topically once daily for up to 14 weeks in at least 196 subjects diagnosed with Diabetes Mellitus and having a single target non-healing Plantar Neuropathic Diabetic Foot Ulcer.

This study will evaluate the effect of Helicobacter pylori eradication therapy on the healing of iatrogenic gastric ulcer caused by endoscopic mucosal resection of gastric neoplastic lesions and is a multicenter, randomized, double blind, and placebo controlled trial.

This double-blind, randomized, comparator-controlled Phase II study is designed to establish the safety and efficacy of Zoenasa Rectal Gel compared to mesalamine enema in subjects with left-sided ulcerative colitis, as measured by the modified ulcerative colitis disease activity index (UCDAI), over 6 weeks of treatment. In this study, two cohorts of subjects will receive either Zoenasa-1:4 (1.0g NAC; 4.0g 5-ASA) investigational drug enema therapy or comparator mesalamine enema (4.0g 5-ASA). The study will enroll subjects randomized equally into the 2 cohorts. Each cohort will enroll approximately 60 subjects. The two arms of the trial will be enrolled concurrently in a randomized fashion.

OBJECTIVES: Main objective: To evaluate the effectiveness of plasma rich in growth factors (PRGF) in the treatment of patients with venous ulcers. Secondary objective: To evaluate the safety of plasma rich in growth factors in treating patients with venous ulcers. DESIGN: Randomized, open clinical trial in parallel groups, controlled with conventional treatment. SAMPLE: Over age patients, of primary care centers of Vitoria, with at least one venous ulcers of 6 or more weeks of evolution and 0.5-6 cm of diameter. INTERVENTION: 1-Experimental group: Autologous PRGF administrated once a week (day 1) + conventional treatment administrated twice a week (days 1 and 4)for 12 weeks of treatment, but in those cases where there has been no complete healing in this period, patients will continue the same management protocol to get it. 2-Control group: Conventional treatment twice a week (days 1 and 4)for 12 weeks of treatment. Conventional treatment includes: Cleaning and debridement of the wound, the application of corresponding dressing, and using of antibiotic if necessary in each visit. STATISTICAL ANALYSIS:The primary outcome analysis was done by logistic regression. The crude model and the adjusted model (for confounding variables)will be built. The healing time of ulcers (in days) were analyzed using the Kaplan Meier survival analysis and the corresponding comparison using the log rank test.

The objective of this study is to determine the safety and effectiveness of a device (the KC-002 interactive wound dressing) in the promotion of healing in diabetic foot ulcers as compared with a conventional wound therapy regimen for subjects with Type 1 or Type 2 diabetes mellitus. This is a prospective, randomized, multi-center, unmasked, controlled study. All patients will receive care for the diabetic foot ulcer during the study. Participation in the study is for 24 weeks.

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.

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.