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Ulcer clinical trials

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NCT ID: NCT04147598 Completed - Ulcerative Colitis Clinical Trials

Diet Study on Ulcerative Colitis

Start date: February 25, 2015
Phase: N/A
Study type: Interventional

The primary purpose of this study is to determine the effectiveness of a low-fat or standard American diet (high in fat) in helping people with ulcerative colitis improve their symptoms and the signs of inflammation in blood tests and in bowel biopsies.

NCT ID: NCT04145154 Completed - Diabetic Foot Clinical Trials

Plasma and Scarring of Diabetic Ulcers

Start date: June 5, 2018
Phase: N/A
Study type: Interventional

Diabetic foot is defined by World Health Organization as a syndrome in which the presence of neuropathy, ischemia and infection cause tissue damage or ulcers from minor trauma. This condition can be controlled in its early stages with conservative treatment, which is effective in preventing infections and amputations. However, even with the new knowledge acquired and the development of new therapies, the specialist often faces wounds that do not improve despite the proper treatment, so therapies have been sought to help the healing of these Ulcers. Growing evidence suggests that healing of chronic diabetic foot ulcers depends on growth factors and that the therapeutic use of these in wounds has the potential to accelerate their healing in conjunction with wound care Conventional. This study evaluates the effect of plasma rich in autologous growth factors on healing chronic ulcers of diabetic origin. This is a randomized clinical trial that evaluates two study groups. Control group in which advanced weekly healing will be performed while the post-advanced healing study group will be performed the intradermal application of plasma rich in growth factors. These manoeuvres will be performed once a week for four weeks and at the end of the study the results in both groups will be checked. Both groups will also evaluate, frequency and intensity of pain, quality of life, histological changes in ulcers and metabolic evaluation

NCT ID: NCT04134676 Completed - Chronic Ulcer Clinical Trials

Therapeutic Potential of Stem Cell Conditioned Medium on Chronic Ulcer Wounds

Start date: June 1, 2019
Phase: Phase 1
Study type: Interventional

Chronic wounds (CW) still represents a heavy burden to many patients and health care institution. Despite the most recent advances in wound management, up to 50% of chronic wounds still fail to heal. Conventional treatment of chronic wounds does not seem to work in several cases, consumes enormous amount of money and time, so it is necessary to develop different strategies. Previous studies have reported stem cells ability in tissue regenerations due mainly to its secreted paracrine factors, rather than its differentiation ability to become new cells. The factors is called secretomes, microvesicles, or exosomes, that can be found in the medium where the cells are growing, therefore it called conditioned medium (CM). Mesenchymal stem cells (MSCs) such as Wharton's Jelly Mesenchymal Stem Cells (WJ-MSC) appear to emerge as a promising wound healing therapy. To the best of investigator's knowledge, after conducted a pilot study using animal model to gain the preliminary data for the ulcer healing potential, this is the investigator's first clinical study to see the therapeutic potentials of Conditioned Medium Stem Cell as an additional growth factors in chronic skin ulcer healing and to compare the success of chronic ulcer healing in patients undergoing CM treatment and standard approach. The investigators will examine the therapeutic effect of human WJ-MSC-CM in wound healing on patients with chronic skin ulcer.

NCT ID: NCT04104451 Completed - Diabetic Foot Ulcer Clinical Trials

PHASE 1, OPEN-LABEL SAFETY STUDY OF UMBILICAL CORD LINING MESENCHYMAL STEM CELLS (CORLICYTE®) TO HEAL CHRONIC DIABETIC FOOT ULCERS

Start date: November 12, 2019
Phase: Phase 1
Study type: Interventional

Study Objective: The objective of this Phase 1 open-label study is to establish the safety and tolerability of Corlicyte mesenchymal stem cells (MSCs) in the treatment of patients with chronic diabetic foot ulcers (DFUs).

NCT ID: NCT04102852 Completed - Clinical trials for Ulcerative Colitis Chronic Moderate

Lactobacillus Rhamnosus GG (ATCC 53103) in Mild-moderately Active UC Patients

LGGinUC
Start date: September 30, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a randomized double-blind clinical trial that intends to evaluate the efficacy and safety of LGG administration at two different doses, for 1 month, in ulcerative colitis (UC) patients with mild-moderate disease activity in therapy with oral mesalamine. Efficacy of therapy will be evaluated by clinical (Clinical Mayo score, quality of life assessment), endoscopic (Endoscopic Mayo score), histological, biochemical (white cell count, C-reactive protein), and molecular (mucosal colonization of the bacteria, pro- and anti-inflammatory cytokines measurement) parameters. UC patients with mild-moderately active disease despite oral treatment with mesalamine will be assessed at baseline for clinical, endoscopic, histologic inflammatory activity. After a wash-out period of 4 weeks of mesalamine, patients will be randomized to assume a regular (LGG 1.2 × 10^10 Colony Forming Units (CFU)/day, 2 capsules a day) or a double (LGG 2.4 × 10^10 CFU/day, 4 capsules a day) dose of LGG for 1 month. At the end of the treatment, clinical, endoscopic, and histologic inflammatory activity will be evaluated and compared to pre-treatment data. Adhesion and molecular effect of LGG will be also evaluated. Safety will be assessed by weekly phone calls and with direct physical examination at the end of the study period.

NCT ID: NCT04090411 Completed - Clinical trials for Moderate to Severe Ulcerative Colitis

A Study to Evaluate the Efficacy and Safety of PF-06480605 in Adults With Moderate to Severe Ulcerative Colitis

Start date: December 19, 2019
Phase: Phase 2
Study type: Interventional

This phase 2b study is designed to have all subjects go into a 12 week induction period to compare different doses of study drug against placebo. After induction is complete all subjects will receive active therapy for 40 weeks, followed by a 12 week follow up period.

NCT ID: NCT04077671 Completed - Clinical trials for Diabetic Neuropathic Foot Ulcers

CHF6467 SAD and MAD in Patients With Diabetic Foot Ulcer

Start date: October 17, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

To assess the safety and tolerability of single and multiple days' topical dosing with CHF6467 in subjects with diabetic foot ulcer (DFU).

NCT ID: NCT04071405 Completed - Ulcerative Colitis Clinical Trials

Korea Post-marketing Surveillance for Xeljanz (Registered) in Ulcerative Colitis Patients

Start date: May 12, 2020
Phase:
Study type: Observational

As required for new medications approved by the Ministry of Food and Drug Safety, safety and efficacy information should be provided for a minimum of 90 patients treated in the setting of routine practice during 4 years following approval (until 19 September 2022). Out of all the enrolled patients, at least 18 cases (20%) will be followed up until the 52nd week to see the long term safety of Xeljanz.

NCT ID: NCT04065724 Completed - Diabetes Mellitus Clinical Trials

Exercise for People With Peripheral Neuropathy and Diabetic Foot Ulcers - a Case Series on Feasibility and Safety

Start date: February 2013
Phase: N/A
Study type: Interventional

Physical training is one of the cornerstones within the treatment of diabetes, as well as medicine and diet modification, and the effect is well documented. Nevertheless people with diabetes with foot ulcers are urged to lessen their level of physical activity, to reduce pressure on footbed and thereby achieve fastest possible healing. Purpose: The primarily purpose is to investigate the feasibility of implementing safe, progressive resistance training, combined with exercises for ankle mobility and aerobic training, for people with diabetes and foot ulcers, without compromising the ulcer. The secondarily purpose is to investigate whether this form of training is effective on improving muscle strength, as to if limitations in everyday life diminishes. The hypothesis is, that it is possible to implement a structured exercise program without compromising the diabetic ulcer.

NCT ID: NCT04065594 Completed - Ulcer Foot Clinical Trials

Platelet Rich Plasma (PRP) Bio Stimulant Gel Dressing in Treating Chronic Non Healing Leg and Foot Ulcers: Cost and Effectiveness

Start date: June 1, 2017
Phase: N/A
Study type: Interventional

Background Chronic non-healing ulcer is a common problem met in clinical practice and represents a burden to the patients. Chronic ulcer lacks growth factors (GFs) to promote the healing process and is frequently followed by superadded infections. Ordinary technique such as wound debridement and regular dressings cannot provide adequate results as these techniques cannot provide the necessary GFs. Platelet-rich plasma (PRP) helps wound healing by releasing various types of GFs. The aim: to evaluate and compare the efficacy of PRP dressing versus traditional dressings in the treatment of chronic non-healing leg and foot ulcers of different etiology as regard cost of overall treatment and effectiveness (reduction of the size of the ulcer and safety of the technique). Methods This prospective study was performed on inpatients and outpatients in general surgery department, Zagazig university hospital from June 2017 to January 2019. Patients were divided randomly into two groups: group A received PRP dressing (N=22, 50%) and group B received conventional ordinary dressing (N=22, 50%).The mean follow-up period was 3 months after the last dressing. Patients treated with PRP at once-weekly interval for a maximum of 12 dressings while patients with ordinary dressings may need one dressing every other day for a maximum of 12 weeks. The reduction in the size of the ulcers (area and volume) in both groups was assessed using centimeter scale and Digital photographs before and after each session and during follow up period. Keywords: Platelet-rich plasma, ulcers, non-healing, ordinary dressing.