Postmarket Study to Evaluate Biovance® in Diabetic Foot Ulcers
Diabetic Foot UlcersThe 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®.
High Dose Esomeprazole Na for Prevention of Rebleeding After Successful Endoscopic Therapy of a...
Bleeding Peptic UlcerTo describe the rate of clinically significant rebleeding during 72 hours continuous i.v. infusion of high dose esomeprazole Na in patients in China with primary successful endoscopic haemostatic therapy of a bleeding peptic ulcer, with cimetidine i.v. in
Evaluation of PillCam IBD Capsule Endoscopy System in Visualization of Lesions in the Colon Indicative...
Ulcerative ColitisStudy Hypothesis UC Disease affects the colon. PillCam IBD may be used for visualization of the colon mucosa in UC Disease patients. This study is designed to evaluate the yield and clinical impact of IBD capsule in detecting lesions associated with UC Disease and to determine the agreement between PillCam Platform with the IBD capsule and optical colonoscopy in the evaluation of UC disease extent. Primary Scientific Objective To evaluate the agreement between PillCam IBD system and optical colonoscopy in the evaluation of UC disease extent (Non-active disease, Proctitis, Left-sided colitis, Pancolitis) Proposed Design Established UC disease patients whose clinical condition suggests ongoing disease activity, aged 18 years and up, who have no evidence of symptomatic stricture or other obstruction that would prevent capsule passage will be enrolled in this study. Patients will undergo bowel prep, followed by a PillCam IBD capsule examination and colonoscopy examination. The Rapid videos will be evaluated by two readers, each from a different site, the colonoscopy videos will be evaluated by two other physicians, at the sites INCLUSION CRITERIA All subjects must fulfill all of the following inclusion criteria: Patients ages 18 years and up Patient has known UC according to physician discretion Patient has at least one positive inflammatory marker from the following: ESR CRP CBC Patient is indicated and eligible for a standard of care colonoscopy examination Patient agrees to sign consent form EXCLUSION CRITERIA The presence of any of the following will exclude a patient from study enrollment: Crohn's Disease Antibiotic Associated Colitis Stool positive for O&P (C&S within 3 months of enrollment) Other known infectious cause of increased symptoms Known intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting. Definite long stricture seen on radiological exam. Non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or more) during the 4 weeks preceding enrollment Suspected GI stricture, followed by patency capsule study or other imaging study that could not prove patency of the GI tract. Patient has had prior abdominal surgery of the gastrointestinal tract in the last 6 months, other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator. Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule. Patient with known gastrointestinal motility disorders. Subjects with known or suspected delayed gastric emptying Patient suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions. Patient has Type 1 or Type II Diabetes. Patient has any allergy or other known contraindication to the medications used in the study. Patient has any condition, which precludes compliance with study and/or device instructions. Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception. Concurrent participation in another clinical trial using any investigational drug or device. Patient suffers from a life threatening condition Patients with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
The Use of an Oral Mixture of Arginine, Glutamine and Beta-hydroxy-beta-methylbutyrate for Treatment...
Pressure Ulcers Stage IIIPressure Ulcer1 moreTo investigate whether an oral nutritional supplement of a mixture of arginine, glutamine and HMB for a maximum period of four weeks is more beneficial than the standard dietary approach to the healing of pressure ulcers, and to examine whether the use of it can reduce admissions and length of hospitalizations for these patients.
Clinical Evaluation of Topical Coenzyme Q10 in Management of Oral Aphthous Ulcer
Oral Aphthous UlcerRecurrent oral aphthous ulcer is the most common oral lesion in occurrence and one of cause is oxidative stress so investigators need to use antioxidant drugs like topical coenzyme Q10 gel to treat the lesion and more safe for the participants.
Prevention of Pressure Ulcer on the Sacrum
Pressure Ulcer RiskThe aim of the present study was to assess whether the application of a multilayered dressing made of hydrocellular polyurethane foam conformed to the sacral area (MSP) in addition to standard preventive care reduces the rate of pressure ulcer (PU) and their severity in population at risk admitted in acute care Hospital.
The Use of Web-app Constant-Care in Patients With Acute Severe Ulcerative Colitis Treated With Rescue...
Ulcerative ColitisTelemedicineThe primary aim is to evaluate if introduction of eHealth in its form of the web application Constant-Care (https://ibd.constant-care.com) could reduce the length of hospitalization in patients with acute severe Ulcerative Colitis treated with infliximab. This is relative to historical controls extracted from medical records. Patients will self-measure on the web-application while hospitalized as well as after discharge. At the web-application different questionnaires are filled out and a fecal calprotectin (FC) analysis is performed on a smartphone. The final follow up is one year after admission.
Prevention of Secondary Foot Ulcers in Patients With Diabetes Using Systematic Measuring of Skin...
Foot UlcerDiabeticA randomised controlled pilot study on the feasibility of introducing a skin temperature device (Temp Touch) in secondary prevention of foot ulcers in people with diabetes who have had a foot ulcer in Norway.
Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers
Diabetic Foot UlcersThis study compares two standard methods for cleaning the surface of wounds on the feet of patients with diabetes mellitus. The question being asked is whether inflammation of the wound affects the ability of one or both of the methods to work.
Pentasa Once Daily in Ulcerative Colitis for Maintenance of Remission
Ulcerative ColitisThis is a multi-centre, randomised, controlled, investigator blinded study. The randomisation will be done centrally. The patients will be treated for 1 year, with clinical and laboratory assessments at 0, 4, 8 and 12 months. Endoscopic examination is at enrollment and on completion of the study (at relapse or after 12 months). Number of Subjects (Planned and Analysed): 360 patients for demonstration of non-inferiority between once daily and twice daily; 326 to be analysed in per-protocol (PP) analyses; and 360 in intention-to-treat (ITT) analyses.