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Ulcer clinical trials

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NCT ID: NCT03942081 Recruiting - Clinical trials for Foot Ulcer, Diabetic

Diabetic Foot Ulcer Imaging- Study 2

Start date: September 5, 2017
Phase: N/A
Study type: Interventional

All study procedures will occur during one appointment. The research team will measure the size of the foot ulcer (if one is present) and multiple photos will be taken with a smart phone camera and thermal camera. Demographic information will be obtained from the medical record.

NCT ID: NCT03937609 Recruiting - Colitis, Ulcerative Clinical Trials

TITRATE (inducTIon for acuTe ulceRATivE Colitis)

TITRATE
Start date: September 4, 2019
Phase: Phase 4
Study type: Interventional

The aim of this study is to investigate whether intensive, personalized IFX dosing by using a pharmacokinetics driven dashboard system during the induction phase in patients with acute severe UC leads to increased treatment success (as defined by clinical and endoscopic response at week 6) as compared to the standard dosing.

NCT ID: NCT03917095 Recruiting - Clinical trials for Ulcerative Colitis Chronic Moderate

The Safety and Efficacy of TET Enema in the Treatment of UC

Start date: May 15, 2019
Phase: N/A
Study type: Interventional

Colonic Transendoscopic enteral Tubing(TET) is a novel, safe, convenient, and reliable procedure for Fecal Microbiota Transplantation(FMT).This clinical trail aims to evaluate the efficacy and safety of Mesalazine and Compound Glutamine enema in the treatment of Ulcerative Colitis through Colonic TET.

NCT ID: NCT03912714 Recruiting - Colitis, Ulcerative Clinical Trials

COlonic Salvage by Therapeutic Appendectomy.

COSTA
Start date: August 24, 2018
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT03907631 Recruiting - Clinical trials for Severe Ulcerative Colitis

Multi-centre Acute Severe Ulcerative Colitis Prospective Cohort Study (Elevate ASUC)

ELEVATE-ASUC
Start date: October 18, 2019
Phase:
Study type: Observational

Up to one third of patients with Ulcerative Colitis (UC) will require hospitalisation for severe disease (ASUC - Acute Severe Ulcerative Colitis), often within the first 12 months of diagnosis. 30-40% of people admitted to hospital with ASUC will require colectomy during the emergency admission. Investigators will develop a multi-centre prospective inception cohort of patients with ASUC with homogeneously collected detailed longitudinal clinical, endoscopic and laboratory data.

NCT ID: NCT03872726 Recruiting - Ulcerative Colitis Clinical Trials

Development and Validation of a Self-reported Objective Index of Work Disability in Inflammatory Bowel Disease

IBD-OWDI
Start date: March 1, 2019
Phase:
Study type: Observational [Patient Registry]

Background theme Crohn's disease (CD) and ulcerative colitis (UC) are chronic diseases that alternate flares of active inflammation with periods of clinical remission. The working capacity of patients may be affected both by disease activity and by the aggressive treatment or surgical intervention required for the management of the disease and its complications. Work disability and impairment are especially important in patients with inflammatory bowel disease (IBD) because the disease affects young individuals who are generally employed and fully active. Although there are several indexes in the literature that assess the degree of work disability due to IBD, all have a high degree of subjectivity, so none can be used to request disability pensions. Experience of the research group on the subject Our group has developed a line of research on work disability associated with IBD. Initially the investigators have studied the parameters that condition the granting of disability pensions of Spanish courts. Subsequently, a population study of the prevalence of work disability in Spain has been carried out. Finally, the investigators develop and validated a disability index for CD (published in its extensive and reduced form) and for UC (currently under review). Hypothesis The IBD generates a work disability that can be measured objectively. Establishing the parameters related to disability is essential to promote equity in administrative and judicial decisions related to the granting of disability pensions to patients with IBD. Objective Development and validation of an objective index to measure the degree of disability in IBD. Material and methods: Study 1: A self-reported and objective questionnaire of disability will be developed based on the data of the population survey already carried out by our group. Patients from a previous study (n 293) will be included. The relationship of different objective variables and disability outcomes will be analyzed with a univariate and a subsequent multivariate analysis. Alternative work disability scores will be developed. Study 2: for the validation of the questionnaire a new online interview will be performed, patients from patients' assocations will be asked to participate. Data Collection: patients will answer a online survey administered with the SurveyMonkey © platform. Participant will answer questions about demographics, disease activity, treatment and complications and data regarding disability. Patients will also complete the SCDWDQ (Short Crohn's Disease Work Disability Questionnaire), Work Productivity and Activity Index (WPAI), IBDQ-9, the EuroQol and IBD-DI (IBD disability index). Statistical analysis: psychometric properties of the index will be evaluated: 1. Convergent validity: the Spearman correlation will be used to correlate the objective disability score with IBD-DI and SCDWDQ. 2. Discriminant validity: it will be measured by the t-test among patients with different degrees of disability (inactive-active, hospitalization-no hospitalization, surgery-no surgery).

NCT ID: NCT03869905 Recruiting - Ulcerative Colitis Clinical Trials

Aquamin® as an Adjuvant Intervention for Ulcerative Colitis

Start date: August 8, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if Aquamin® works as a potential treatment to improve symptoms and if it will induce remission in patients with mild Ulcerative Colitis and extend remission in Ulcerative Colitis in remission.

NCT ID: NCT03863886 Recruiting - Ulcerative Colitis Clinical Trials

Endoscopic Ultrasound Determines Disease Activity in Crohn's Disease And Ulcerative Colitis

EUSIBD
Start date: January 4, 2019
Phase: N/A
Study type: Interventional

Although Crohn's disease and ulcerative colitis are the main subtypes of inflammatory bowel disease, they differ substantially in disease behavior, prognosis, and treatment paradigm. However, making an accurate diagnosis of Crohn's disease versus ulcerative colitis and assessing disease activity beyond the level of mucosal inflammation remain challenging with contemporary modalities. The objective of the study is to determine the novel role of endoscopic ultrasound in A) differentiating Crohn's colitis versus ulcerative colitis and B) monitoring disease activity in these patients.

NCT ID: NCT03855514 Recruiting - Diabetic Foot Ulcer Clinical Trials

Randomized Clinical Study Assessing NuShield Versus Standard of Care in Diabetic Foot Ulcers

DFUs
Start date: February 8, 2019
Phase: N/A
Study type: Interventional

This prospective, multi-center, randomized, controlled clinical study compares NuShield® plus SOC to SOC alone in subjects with chronic DFUs. NuShield® will be used along with standard of care on diabetic foot ulcers of greater than 6 weeks which have not adequately responded to conventional ulcer therapy.

NCT ID: NCT03843385 Recruiting - Ulcerative Colitis Clinical Trials

Transfer of FRozen Encapsulated Multidonor Stool Filtrate for Active Ulcerative COlitis

FRESCO
Start date: January 31, 2023
Phase: Phase 3
Study type: Interventional

FRESCO is a randomized, longitudinal, prospective, three arm, multicentre, double blind study to determine safety and efficacy of repeated faecal microbiota transplantation (FMT) or faecal microbiota filtrate transplantation (FMFT) compared to placebo using oral, frozen capsules in 174 randomized patients with mild to moderate active Ulcerative Colitis.