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Ulcer clinical trials

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NCT ID: NCT06023810 Not yet recruiting - Clinical trials for Foot Ulcer, Diabetic

The Effect of Motivational Interviewing on Treatment Adherence, Self-Efficacy, and Satisfaction in Individuals With Diabetic Foot Ulcers

Start date: September 2023
Phase: N/A
Study type: Interventional

The rise in diabetes incidence has led to a corresponding increase in diabetes-related complications. Diabetic foot ulcers, a severe consequence of diabetes, have substantial impacts on patients, the social environment, overall well-being, and nursing procedures. Given this context, there is a clear necessity for interventions that motivate patients to adopt beneficial health behaviors and educate them in effectively managing diabetes-related complications. This study seeks to investigate the impact of Watson's motivational interviewing method, which is grounded in the human care theory, on enhancing treatment adherence, self-efficacy, and satisfaction levels among individuals suffering from diabetic foot ulcers. Hypotheses of The Research H0: There is no difference in self-efficacy for diabetic foot care, diabetic foot care behavior, treatment adherence, and satisfaction between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education, and those who receive standard education. H1: There is a difference in self-efficacy for diabetic foot care between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education and those who receive standard education. H2: There is a difference in diabetic foot care behavior between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education and those who receive standard education. H3: There is a difference in treatment adherence between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education and those who receive standard education. H4: There is a difference in satisfaction between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education and those who receive standard education.

NCT ID: NCT06020664 Suspended - Diabetic Foot Ulcer Clinical Trials

NOX1416 in Treatment of Chronic Non-Healing Diabetic Foot Ulcers (NTCDU)

NTCDU
Start date: August 16, 2023
Phase: Phase 1
Study type: Interventional

The goal of this multi-center,randomized, placebo controlled, evaluator-blinded study is to assess the efficacy and safety of NOX1416 in the treatment of chronic, non-healing, diabetic foot ulcers (DFUs). Subjects will be randomized to receive treatment with NOX1416 or placebo as an adjunct to SOC. The primary objective of the study is to evaluate the clinical benefit of daily NOX1416, as an adjunct to standard of care (SOC), in the treatment of chronic, non-healing DFUs. The secondary objective is to demonstrate efficacy, safety and tolerability of NOX1416 as adjunct to SOC. Each site will assign a physician (or designee) to serve as the "blinded-evaluator" to be responsible for assessing the study endpoints such as wound measurements and complete wound closure. The blinded-evaluator will not be involved in the clinical care of the subject.

NCT ID: NCT06013696 Active, not recruiting - Ulcerative Colitis Clinical Trials

Bleach and Urine Color in UC Patients Using 5ASA

Asableach
Start date: July 16, 2023
Phase: N/A
Study type: Interventional

The aim of this study is to evaluate the effect on urine color by adding household bleach to fresh urine sample among pediatric UC subjects treated with 5ASA

NCT ID: NCT06013202 Not yet recruiting - Aphthous Ulcer Clinical Trials

The Efficacy of Nigella Sativa Oil Mouth Rinse in the Management of Recurrent Minor Aphthous Ulcer

Start date: September 22, 2023
Phase: N/A
Study type: Interventional

This research aims to investigate the effectiveness of Nigella Sativa Oil Mouth Rinse application both clinically and biochemically as a suitable affordable treatment modality for Management of Recurrent Minor Aphthous Ulcer

NCT ID: NCT06007703 Not yet recruiting - Venous Leg Ulcer Clinical Trials

Evaluation of the Efficacy of Multilayer Compression & UrgoStart Plus

Start date: October 2, 2023
Phase:
Study type: Observational

Historically, venous leg ulcers have been very difficult to manage, with associated poor healing rates, and the likelihood of recurrence. Even following correction of underlying venous dysfunction, ulcers can take time to respond to conventional treatment with compression therapy. Recently, the leg ulcer service in Gloucestershire - part of the vascular surgical team - have been using an interactive dressing called UrgoStart Plus under compression therapy in the management of chronic venous leg ulcers and we have experienced some positive outcomes for otherwise recalcitrant ulcers. A previous study published in 2017 by Meaume et al demonstrated a reduction in wound surface area after 8 weeks of treatment with UrgoStart Plus. However, whether or not use of the dressing, in combination with compression bandages, improves 12-week healing rates, remains an unanswered question. The aim of the proposed study is to provide an evaluation of this interactive dressing when used under compression bandages and to compare 12-week healing rates with a similar cohort of patients who have been treated with a simple low adherent dressing under compression. This has been our gold standard up to now and we have been collecting prospective data from patients treated in our unit.

NCT ID: NCT06003530 Active, not recruiting - Diabetic Foot Ulcer Clinical Trials

Study for Treatment of Chronic Diabetic Foot Ulcers With the Investigational Allogeneic Cell Therapy Product, hOMSC200

Start date: January 6, 2022
Phase: Phase 1
Study type: Interventional

Purpose of this phase 1/2a study is to assess the safety and efficacy of administration of allogeneic human oral mucosal stem cells (hOMSCs) in patients suffering from chronic diabetic foot ulcers (DFU).

NCT ID: NCT06003400 Recruiting - Diabetic Foot Ulcer Clinical Trials

Proof of Concept Open Label, Clinical Trial to Evaluate the Safety and Efficacy of the "FITT" Device in Diabetic Foot Ulcers Patients

TriO FITT
Start date: March 29, 2023
Phase: N/A
Study type: Interventional

The TriO FITT device is designed to improve the symptoms of chronic diabetic ulcers. The mechanism of action of the device optimizes and combines the administration known supproting treatments to chronic diabetic ulcers. The treatment is astimated to improve the wound conditions of acute and chronic diabetic wounds.

NCT ID: NCT06000722 Completed - Diabetic Foot Ulcer Clinical Trials

SGLT-i Use in Diabetic Foot Ulcer Disease

Start date: December 5, 2023
Phase:
Study type: Observational

Background: People with diabetes and either current or previous diabetic foot ulcer disease (DFUD) are at very high risk for adverse cardiovascular events including heart attacks and strokes. Sodium-glucose co-transporter 2 (SGLT2) inhibitors are a class of medications that have shown to be very effective in reducing heart disease and event risk. However, one recent study found that SGLT2i's may increase minor amputation risk in those with DFUD, though this finding has not been replicated in other similar studies. However, as a result, there has been limited further investigation into this issue and as such the use of SGLT2i's in those with DFUD remains a contentious issue, despite their potential for significantly reducing cardiovascular disease risk in this population. In the absence of further randomised controlled trials investigating the use of SGLT2is in these populations, there is a need for clinical guidelines advising on their use based on expert clinical consensus, including specific criteria or scenarios in which they should or should not be used. The Delphi methodology is an iterative survey technique that uses expert opinion from various relevant backgrounds and experiences to generate a consensus based upon various statements and/or scenarios. Aim: The aim of this study is to use the Delphi technique to generate expert consensus-based clinical guidelines on the use of SGLT2i's in those with diabetes and DFUD. Methods: This is a Delphi technique-based study using a purposive sample of convenience. Consensus development methods will be used to generate clinical guidelines, endorsed by key clinical groups, on the use of SGLT2i's in patients with diabetic foot ulcer disease, including acknowledgement of specific scenarios or patient characteristics that may influence these guidelines. The consensus group will consist of n=20 healthcare practitioners, including GPs, secondary care diabetologists, foot care specialists, cardiologists and pharmacists in order to ensure a breadth of expertise and input. Two rounds of the Delphi consensus process will take place, in order to iteratively develop the consensus-based clinical guidelines. This process is expected to take 4-6 months. The analysis will be on-going throughout the study and completed within 3 months of the last questionnaire round of the Delphi process.

NCT ID: NCT05998213 Recruiting - Ulcerative Colitis Clinical Trials

Transfer of Feces in Ulcerative Colitis 2

TURN2
Start date: December 5, 2018
Phase: Phase 2
Study type: Interventional

The goal of this placebo-controlled randomised multicenter trial is to evaluate the efficacy and safety of anaerobic prepared donor fecal microbiota transplantation (FMT) compared to autologous FMT in patient with ulcerative colitis. Participants will receive 4 treatments with frozen FMT via both upper and lower gastro-intestinal route (infusion via duodenal tube and enemas). Donors are selected based on microbiota profile.

NCT ID: NCT05992142 Completed - Ulcerative Colitis Clinical Trials

ChAracterizing the Remission Status in Patients With Ulcerative Colitis Treated by 5-ASA

CARUC-ASA
Start date: January 17, 2023
Phase: Phase 4
Study type: Interventional

For the last years the aim of the management of ulcerative colitis (UC) has become more ambitious including not only clinical remission but also the achievement of biological remission, endoscopic and histological healing, which are associated with less flares, hospitalizations and surgeries. About 50% of the patients with UC followed in routine are treated by 5-aminosalicylate acid (5-ASA) (oral and/or topical). The aim of the study is to describe the different levels of remission (clinical, endoscopic, histological) in UC patients treated only by 5-ASA, that report to be in clinical remission during a routine follow-up visit. The factors associated with different levels of remission (demographic, 5-ASA regimen, biologic, endoscopic, histologic) will be studied. Adherence and quality of life will be examined through patient questionnaires.