Active clinical trials for "Ulcer"

This is a prospective study of participants with diabetic foot ulcers who will receive either maggot debridement therapy (MDT) or conventional dressing therapy (CDT). Wound healing time is the main outcome measure to compare the clinical efficacy of these two therapies. The investigators developed a hypothesis that MDT could achieve remarkable shorter time and better healing rate for wound closure when compared with CDT.

An observational, prospective cohort study to evaluate the safety and efficacy of Remsima™ in patients with Crohn's disease (CD) or Ulcerative Colitis (UC)

Autologous platelet-rich plasma (PRP) gel was reported to have very good outcomes in the treatment of foot ulcers in pilot studies and retrospective uncontrolled trials. Therefore, a larger randomized, placebo-controlled clinical trial will be useful to determine whether platelet-rich plasma is safe and effective for the treatment of diabetic foot ulcers (DFU).

This project is a double-blind, randomized, placebo-controlled, multicenter trial in the Netherlands. The aim of this study is to investigate the therapeutic efficacy of optimized 6-mercaptopurine (6-MP) in ulcerative colitis patients. Therapeutic drug monitoring (TDM) will be performed in order to optimize treatment outcomes and objective endoscopic endpoints will be used.

Rationale: The annual incidence of ulcerative colitis (UC) amounts to 6-8 new cases per 100.000. Patients are initially treated medically, and colitis refractory to medical management is treated surgically, mostly by means of an (emergency) colectomy or a proctocolectomy with ileal J-pouch anastomosis. Over the past 10 years evidence has been accumulating indicating that the appendix has an immunomodulatory role in patients with UC reducing the need for medication and perhaps even colectomy. Objective: The objective of this prospective observational cohort study is to evaluate the effect of appendectomy on the disease course of patients with active ulcerative colitis despite standard step-up treatment including biologicals. The second objective is to determine if histological inflammation in the appendix resection specimens can be reliably predicted by pre-operative endoscopic biopsies of the appendix and correlated to clinical and pathological response after appendectomy. Study design: The design of the study is a prospective observational cohort study of 80 consecutive patients. Study population: Sixty patients of 18 years and older, with established diagnosis of UC and ongoing disease activity despite standard step-up treatment including biologicals. Furthermore, histological characteristics in appendix biopsies of 10 patients with non-active UC and 10 'healthy control' patients (e.g. patients undergoing endoscopy for polyps) will be evaluated and used as a reference control group. Intervention: Patients will undergo laparoscopic appendectomy in clinical or day care setting. Main study parameters/objectives: The primary outcome parameter is the number of patients achieving remission (Total Mayo score ≤2) 12 months after appendectomy. Secondary endpoints are reduction of medical therapy, the disease activity as measured with the Mayo score, colectomy rate, the health related quality of life and costs (EQ-5D, EORTC-QLQ-C30-QL and IBDQ), and histological appendix characteristics predictive of response.

Lower extremity complications such as chronic diabetic foot ulcers (DFUs) are a major risk for Type I/II diabetes patients. Minor injuries that would normally heal without consequence in non-diabetic individuals are at greater risk of bacterial infection and progression to non healing (chronic) wound status in diabetics, largely due to a loss of sensation in limbs (neuropathy) and decreased blood flow (vascular disease). If not treated efficiently and effectively, DFUs can have serious complications e.g. amputation, sepsis and death. The investigators propose to address this significant unmet clinical need using a novel commercial handheld fluorescence imaging product called the MolecuLight i:X (MolecuLight Inc.) which images clinically-significant wound bacteria without contrast agents or patient contact. Evidence in animal models of chronic wounds and multiple published clinical trials (mainly DFUs) have shown significant clinical potential for fluorescence imaging to detect potentially harmful bacteria in wounds otherwise invisible to doctors. The investigators have shown that clinicians can easily, objectively and more accurately determine the likelihood of bacterial infection than the standard of care. Moreover, published clinical evidence has shown fluorescence imaging enables more accurate microbial wound sampling and guides more targeted debridement of wounds to reduce bacteria levels. Our pilot data also show that when used like this, the i:X device accelerates DFU wound healing, compared with current methods. Thus, the investigators propose to expand the current pilot studies through a statistically-powered 3 y randomized controlled trial to test the therapeutic benefit of fluorescence-guided treatment for DFUs in a larger group of patients. A successful trial could help reduce DFU healing times compared with standard practice (using a new Canadian product) and improve patient quality of life, reduce amputation risk and alleviate health care costs for diabetes complications in Canada and beyond.

This project is based on investigator team's ten year experience on diabetic ulcer and goes on further developing basic research and concluding clinical experience. The investigator team has recently developed "Remove stasis to generate granulation tissue" into "Remove slough to generate granulation tissue". Investigators have applied the principle of "Remove stasis" in the medium and later stage of treatment to make "Remove slough-Eliminate stasis-Generate granulation tissue" become the basic principle of three-stage sequential treatment. Investigators will further conclude Chinese medicine therapy in the stage of "Qing-Hua-Bu" and evaluate safety, applicability and availability of it. Therefore, the research can help improve clinical diagnosis and treatment technique and transfer the study result of Chinese medicine experience on diabetic ulcer.

The purpose of this study is to describe in real life the effectiveness of treatment with vedolizumab.

The purpose of this study is to evaluate an empowerment-based program. A randomized controlled trial design will be used. From August 2019 to July 2021, 160 subjects will be recruited at a medical center and randomly assigned to the intervention or comparison group. Participants in the intervention group will receive an assessment of their self-care demand and self-efficacy, as well as an empowerment-based program delivered by the project host. The program includes the identification of the problems of participants, clarification of their feelings and the significance of their problems, plan setting discussion, motivation for action, and evaluation of the execution of their plan. Empowerment-based strategies will be provided individually at the following time points: before discharge, on post-discharge days 3, 7, 14, 21, 28, 42, 56, 70, and 84, and at 6, 9, and 12 months post-discharge. Those in the comparison group will receive routine care only. Outcome measures include self-care behaviors, glycemic control (measured by HbA1C), diabetic foot ulcer infection, and diabetic foot ulcer recurrence. Data will be collected at baseline and at 1, 3, 6, and 12 months after discharge.

A phase 3,double-blinded, double dummy, parallel, non-inferiority, randomised controlled multicenter trial to evaluate efficacy and safety of 4 weeks treatment of Anaprazole 20mg QD compared with rabeprazole 10mg QD in patients with duodenal ulcers.