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NCT ID: NCT01181440 Completed - Diabetic Foot Ulcer Clinical Trials

Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers

Start date: September 1994
Phase: Phase 3
Study type: Interventional

This study randomly assigns patients with plantar diabetic foot ulcers to receive conventional therapy (debridement, infection control, saline-moistened gauze dressings, and standardized off-weighting) alone or conventional therapy plus Dermagraft(R). Dermagraft is a device containing live human fibroblasts grown on an absorbable polyglactin (Vicryl) mesh. Patients are evaluated weekly until Week 12, then every four weeks until Week 32.

NCT ID: NCT01180179 Completed - Peptic Ulcer Clinical Trials

PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers

Start date: June 2010
Phase: Phase 4
Study type: Interventional

The 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.

NCT ID: NCT01177228 Completed - Ulcerative Colitis Clinical Trials

Study of Vedolizumab Following Multiple Intravenous Doses in Patients With Ulcerative Colitis

Start date: May 2007
Phase: Phase 2
Study type: Interventional

The main objectives of this study were to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of vedolizumab in patients with ulcerative colitis (UC).

NCT ID: NCT01167101 Completed - Stomach Ulcer Clinical Trials

Is Rebamipide Effective on the Healing of Iatrogenic Gastric Ulcer After Endoscopic Mucosal Resection?

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

Treatment strategy of post endoscopic submucosal dissection (ESD) ulcer is not yet conclusive. Rebamipide is a mucosal protective agent widely used in East Asia and has good effect on quality of ulcer healing (QOUH). The investigators will conduct this randomized controlled study to assess the effect of a combination therapy of rebamipide and proton pump inhibitor (PPI) on post ESD ulcer healing.

NCT ID: NCT01154374 Completed - Clinical trials for Diabetic Foot Ulcers

A Clinical Study of the Safety and Efficacy of MEBO® Wound Ointment in Subjects With Diabetic Foot Ulcers (Pilot)

Start date: November 2010
Phase: Phase 2
Study type: Interventional

The objective of this study is to evaluate the safety and efficacy of MEBO in the treatment of subjects with diabetic foot ulcers (DFUs).

NCT ID: NCT01150162 Completed - Gastric Ulcer Clinical Trials

Mucosta in Gastric Ulcer Treatment, Effectiveness and Safety Evaluation

MGES
Start date: October 2010
Phase: Phase 3
Study type: Interventional

A Prospective Randomized, Multi-center study to assess the Safety and Efficacy of Mucosta (Rebamipide), in combination with Omeprazole as adjuvant therapy in Gastric Ulcer Patients.

NCT ID: NCT01149707 Completed - Proctosigmoiditis Clinical Trials

Safety, Tolerability, Efficacy Study of PUR 0110 Rectal Enema in Mild-to-Moderate Distal Ulcerative Colitis

Start date: June 1, 2010
Phase: Phase 2
Study type: Interventional

PUR 0110 is a 100% natural novel investigational medicinal product that has been demonstrated in several in vitro and in vivo pharmacology studies to have potent anti-inflammatory, anti-oxidative and immunomodulatory effects. This exploratory Phase 2a study is a first-in-patient study to evaluate the safety, tolerability, biomarker effect and efficacy of PUR 0110 rectal enema in patients with active mild-to-moderate distal ulcerative colitis (UC). The study is a multicenter, randomized, double-blind, parallel-group, dose-ranging, placebo-controlled study. To be eligible for inclusion into the study, patients must either be newly diagnosed or have on-going active mild-to-moderate distal ulcerative colitis of at least 3 months duration confirmed in either case by flexible sigmoidoscopy and biopsy at the Screening Visit. In addition, patients must have a modified Mayo score of ≥5 to ≤10 including a sigmoidoscopy inflammation grade and rectal bleeding scores of ≥2 each. Eligible patients will be randomly assigned to receive either PUR 0110 250 mg, 500 mg or 1000 mg or placebo rectal enema in a 1:1:1:1 ratio. Patients will self-administer the assigned study medication intrarectally once-daily at bedtime (10:00 p.m +/- 1 hour) for 2 weeks. Patients will be evaluated for safety by adverse events, clinical laboratory tests, vital signs, physical examination, electrocardiogram (ECG), and concomitant medications. Efficacy evaluations will include the modified Mayo score, patient-defined response and remission, Investigator Assessment of Ulcerative Colitis Symptom Score, Inflammatory Bowel Disease Questionnaire (IBDQ), and biomarkers of inflammation, apoptosis and total cell death, lipid peroxidation and in vivo oxidative stress, and antioxidant defense mechanisms in plasma, serum, urine, feces and biopsy tissue. Patients will have a flexible sigmoidoscopy and biopsy 12 hours after the last dose of study medication.

NCT ID: NCT01143727 Completed - Clinical trials for Diabetic Foot Ulcers

Enzymatic Versus (vs) Autolytic Debridement of Diabetic Foot Ulcers

Start date: July 2010
Phase: Phase 4
Study type: Interventional

This 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.

NCT ID: NCT01143714 Completed - Clinical trials for Diabetic Foot Ulcers

A Study to Look at the Effects of Four Weeks of Treatment on the Healing of Diabetic Foot Ulcers

Start date: June 2010
Phase: Phase 4
Study type: Interventional

The purpose of this study is to assess the effect of four weeks of treatment with Santyl Ointment, compared to White Petrolatum, on the change from baseline in wound area of diabetic foot ulcers over four weeks, and on the proportion of subjects achieving complete wound closure within 12 weeks from initiation of treatment.

NCT ID: NCT01142245 Completed - Bleeding Clinical Trials

Effect of IV and Oral Esomeprazole in Prevention of Recurrent Bleeding From Peptic Ulcers After Endoscopic Therapy

IOE
Start date: January 2008
Phase: Phase 3
Study type: Interventional

The investigators previously showed that the use of a high-dose intravenous PPI regimen after endoscopic control of bleeding from peptic ulcers reduced rate of recurrent bleeding, decreased the need for endoscopic and surgical interventions and in general improved patients' outcomes. A trend towards reduced mortality associated with the use of high-dose intravenous PPI was also observed. Recent clinical trials from Asia have provided evidence that high-dose oral PPIs are associated with a reduction in rebleeding. Current meta-analysis suggests that both high dose (intravenous) and low dose (oral) PPIs effectively reduce rebleeding vs placebo. However, there has been no clinical study to compare IV infusion to oral PPI in this patient population. The purpose of this clinical study is to compare the efficacy and safety of intravenous and oral Esomeprazole in patients with peptic ulcer hemorrhage who are at risk for recurrent bleeding. The investigators hypothesize that using IV infusion is superior to oral PPI.