Evaluate the Noninferiority of Medicines Treating Uninfected Pressure Ulcers.
Pressure UlcerThis is a Clinical study Phase III, Prospective, Randomized, Controlled, Double-blind, Multicenter, National, Non-inferiority. Its purpose is to determine the noninferiority in efficacy of an investigational product in relation to the product available in the market intended of treating pressure ulcers.
Berberine Chloride in Preventing Colorectal Cancer in Patients With Ulcerative Colitis in Remission...
Ulcerative ColitisThis randomized, pilot phase I trial studies the side effects of berberine chloride in treating patients with ulcerative colitis and who are in remission (a decrease in or disappearance of signs and symptoms of cancer) to reduce the risk of colorectal cancer. Patients with ulcerative colitis are at increased risk for colorectal cancer. Chemoprevention is the use of drugs, such as berberine chloride, to keep a disease/condition from forming or coming back. The use of berberine chloride may keep colorectal cancer from forming in patients with ulcerative colitis.
Cooling Lower Leg Skin to Prevent Venous Leg Ulcers in Patients With Poor Vein Circulation
Venous DiseaseVenous Vascular Diseases and Syndromes2 moreLeg vein circulation problems can damage the skin of the lower legs, especially around the ankles, by making it discolored, hard, itchy, red, and swollen. Ulcers often develop. Inflammation is often present in the damaged skin. This study will test whether using a special low compression, cooling, boot-like gel wrap placed around the damaged skin of the lower legs will improve the skin circulation and prevent leg ulcers. The study hypothesis is: A cryotherapy, low-compression cooling gel wrap (CW) plus usual care (UC) (leg elevation, compression stockings) intervention compared to a low compression non-cryotherapy "sham" wrap (NW) plus UC will reduce tissue blood flow (perfusion units) and decrease the incidence of venous leg ulcers (VLUs) during the 9-month study period in individuals with Stage 4 and 5 venous insufficiency.
Multi-layer Insoles for a Patient-specific Approach to Shear and Pressure Reduction in Diabetes-related...
Diabetic Foot UlcerDiabetic FootIn this pilot study, the first objective is to bench test a novel shear reducing insole and compare it to current standard insoles and shoes. The second objective is to study twenty-seven insensate diabetes patients with pre-ulcerative foot callus to examine for changes in spatial temporal gait including gait initiation, risk of falling, static and dynamic balance, and plantar temperature response to walking and consecutive plantar stress in both footwear conditions.
Pilot Study Comparing NatroxTM Topical Oxygen Therapy to A Placebo in the Management of Non-Healing...
Skin Ulcer Venous Stasis ChronicMixed Arteriovenous Leg UlcerThe purpose of this study is to determine the effectiveness of the NatroxTM Topical Oxygen device versus a placebo in patients with non-healing leg ulceration in conjunction with standard best practice.
A Study to Investigate the Efficacy and Safety of GSK1605786 for Treatment of Patients With Active...
ColitisUlcerativeGSK1605786 is an oral antagonist specific for the chemokine receptor CCR9 in development for treatment of small bowel and colonic Crohn's disease (CD). The purpose of this Phase II proof of concept study is to investigate the efficacy and safety of GSK1605786 (500 mg twice daily) administered orally for 16 weeks for the treatment of patients with active ulcerative colitis (UC). A key secondary objective is to understand the mechanism by which GSK1605786 is acting and to this end samples will be collected to confirm the degree of inhibition of CCR9 on T lymphocytes in the blood of patients, and to explore the relationship between concentration of drug and changes in lymphocyte and antigen presenting cell populations in the peripheral circulation and in the colon. Patients recruited at specified investigational sites will be invited to participate in an optional sub-study to explore the effects of GSK1605786 on trafficking of technetium labelled T cells using Single Photon Emission Computerized Tomography (SPECT). Specifically, the technique will be used to follow trafficking to large intestine and thymus and findings linked to pharmacokinetics of GSK1605786, receptor occupancy and clinical efficacy outcomes
PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers
Peptic UlcerThe aim of this study is to compare the efficacy of a proton pump inhibitor (lansoprazole) and a histamine-2 receptor antagonist (famotidine) in preventing recurrent ulcer bleeding in patients with a history of H. pylori-negative idiopathic peptic ulcers.
HP011-101, HP828-101, and Standard Care for Pressure Ulcers
Pressure UlcersTesting a drug and a device for the treatment of pressure ulcers, compared with current treatments.
Clinical and Cost Effectiveness of Different Dressing Materials in Diabetic Foot Ulcers
Diabetic Foot UlcersThe purpose of the study is to evaluate the efficacy and safety of different commonly used dressings for treating diabetic foot ulcers. It is a prospective study recruiting 50 type 2 diabetic patients with diabetic foot ulcers (2-50cm2). All the patients will give written informed consent prior to getting enrolled in the study. All the patients will be randomly assigned to one of the five groups of the study namely, saline (control),Biatin Ag (Foam), Hydrocolloid, Hydrogel and Ceredak. Follow up of the patients will be done until the complete healing of the wound takes place. All procedures of dressing will be done by an authorized and certified Podiatric Surgeon of the Institution. Details on the cost incurred and days required for the wound to completely heal will be recorded for all the patients. This study will provide the efficacy of all the dressings used for treating diabetic foot ulcers and also the cost of each dressing. This will help the surgeons for managing the diabetic foot ulcers in a better and cost effective way, which in turn will reduce the burden of patients both physically and financially.
Clinical Trial Evaluating Gastrointestinal Damage Following Administration PL3100 or Naproxen in...
Gastroduodenal UlcerationsErosionThe purpose of this study is to determine the subchronic gastrointestinal (GI) safety of PL3100 versus Naproxen in normal healthy volunteers.