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Ulcer clinical trials

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NCT ID: NCT05165758 Completed - Diabetes Clinical Trials

Comparison of the Quality of Life and the Level of Precarity of a Diabetic Population With and Without Foot Ulcer in Martinique

QVP-Dia
Start date: January 21, 2022
Phase:
Study type: Observational

The aim of this study is to compare quality of life of diabetics with and without foot ulcer. Investigators will compare their quality of life based on the mental health impact of foot ulcer.

NCT ID: NCT05148390 Completed - Diabetic Foot Ulcer Clinical Trials

Study to Examine Clinical Performance and Safety of Cutimed® Gelling Fiber in Routine Clinical Practice

GELFI
Start date: April 24, 2022
Phase:
Study type: Observational

This is a post - market study with a wound dressing, a CE-marked medical device available on the european market. The device will be used in routine clinical practice, i.e. within its intended purpose and without any additional invasive or stressing examinations for the patients. Up to 36 adult patients with wounds suitable to be treated with the medical device and meeting the inclusion/exclusion criteria will be enrolled at two participating German sites. During 5 on-site visits within 28 days routine weekly dressing changes the Health Care Professional will examine the wound and will perform required wound care and dressing changes. Pictures of the wound with and without dressing will be taken at each visit and used for automatic analysis. The subjects will be asked to rate their general wound pain and the pain perceived during dressing changes. A wound-related quality of life questionnaire will be presented to the subjects twice and the subject and HCP will rate their safisfaction with the product.

NCT ID: NCT05147376 Completed - Oral Ulcer Clinical Trials

Effectiveness of a Curcumin Mouthwash in Preventing Traumatic Ulcers in Patients With Fixed Orthodontic Appliances

Start date: February 21, 2022
Phase: Early Phase 1
Study type: Interventional

The study is a randomized controlled trial. The participants will be equally allocated into 2 groups to compare clinical effectiveness of curcumin mouthwash in fixed orthodontic patients during the first month of treatment.

NCT ID: NCT05145439 Completed - Clinical trials for Peripheral Arterial Disease

A Non-significant Risk Clinical Study of Therapeutic Ultrasound for Patients With Diabetic Foot Ulcers.

Dulcet
Start date: January 14, 2023
Phase: N/A
Study type: Interventional

This study is evaluating whether a therapeutic ultrasound device can improve blood flow to the leg with diabetic foot ulcer (DFU).

NCT ID: NCT05142878 Completed - Pressure Ulcer Clinical Trials

What is the Incidence of Pressure Ulcer Category II-IV (Including Deep-tissue Injury and Unstageable) on a Static Air Foam Hybrid Mattress?

Start date: July 15, 2020
Phase: N/A
Study type: Interventional

Pressure ulcers are a serious and common problem for residents admitted to long-term care facilities and community care patients. They represent a major burden to patients, carers and the healthcare system, affecting approximately 1 in 20 community patients. They occur frequently among patients with limited mobility, such as those patients being bed-bound and/or wheelchair-bound. In many countries, pressure ulcers are recognized as a national health issue and governments designate pressure ulcers as one of the most important sentinel events for healthcare. International guidelines recommend the use of pressure redistributing support surfaces, systematic patient repositioning and preventive skin care to prevent pressure ulcers. All interventions should be patient-tailored and based on a thorough assessment of both the patient and contextual risk factors. As pressure ulcers can arise in a number of ways, interventions for prevention and treatment need to be applied across a wide range of settings, including the community, nursing homes and hospitals. A review of mortality and severe harm incidents reported to the National Reporting and Learning System found that pressure ulcers were the largest proportion of patient safety incidents in 2011/2012, accounting for 19% of all reports. It has been acknowledged that a significant proportion of pressure ulcers are avoidable. The prevalence of pressure ulcers is 1 of the 4 common harms recorded in the UK NHS Safety Thermometer, a local improvement tool for measuring, monitoring and analysing patient harms across a range of settings, including nursing homes, community nursing and hospitals on a monthly basis. Continuous low levels or short-term high levels of pressure and shear on the skin and underlying tissue on vulnerable areas are extrinsic factors contributing to the development of pressure ulcers. Support surfaces (e.g. any mattresses, integrated bed systems, mattress replacement, overlay, seat cushion, or seat cushion overlay) are specialized devices for pressure redistribution specifically designed for management of tissue loads, micro- climate, and/or therapeutic functions. A Cochrane systematic review by McInnes et al. (2015) defined multiple groups of pressure redistribution materials: low-tech (not electrically driven) constant low-pressure supports, high-tech supported surfaces, and other supported surfaces (operating table mattress pad, rotating beds, cushions, and limb protectors). Static or reactive overlay mattresses are an example of a low-tech constant low pressure support. Static air mattresses maintain a continuous low air pressure that exerts a pressure redistributing effect. Serraes and Beeckman (2016) found a pressure ulcer incidence of 5.1% in patients placed on static air support surfaces (mattress overlay, heel wedge, and seat cushion) in a high risk population in a nursing home setting in Belgium. A multicentre randomised controlled clinical trial in 26 nursing homes (including 308 residents) between April 2017 and May 2018 resulted in a significantly lower pressure ulcer incidence when applying the principle of static air (n=8/154, 5.2%) compared to the alternating air group (n=18/154, 11.7%)(p=0.04). The median time to develop a pressure ulcer category II-IV was significantly longer in the static air group (10.5 days, IQR 1-14) compared to the alternating air group (5.4 days, IQR 1-12; p=0.05). The study concluded that a static air mattress was significantly more effective compared to an alternating air pressure mattress to prevent pressure ulcers in a high risk nursing home population. This multicentre cohort study will be performed in 5 nursing homes in a random sample of 40 residents who are at high risk of developing pressure ulcers. Residents will be included in the study for a period of 14 days. Skin assessment and risk factor registration will be done on a daily basis by the nurses. Reliability checks and time measurements will be completed by the researcher.

NCT ID: NCT05130814 Completed - Pressure Ulcer Clinical Trials

EmoLED Medical Device Treatment of Second and Third Stage Pressure Ulcers

RISE_UP
Start date: December 1, 2021
Phase: N/A
Study type: Interventional

The present clinical study aims to verify the effectiveness and safety of the blue light photobiomodulation therapy with EmoLED medical device in supporting the reparative process of the area of the second and third stage decubitus lesion, comparing this method with the effectiveness of the therapy commonly used in the clinical field.

NCT ID: NCT05123417 Completed - Pressure Ulcer Clinical Trials

Knowledge and Practices of Preventing Pressure Ulcers

Start date: May 1, 2022
Phase: N/A
Study type: Interventional

Pressure ulcer is defined by the European Pressure Ulcer Advisory Panel (EPUAP) and the National Pressure Ulcer Advisory Panel (NPUAP) as "localized skin and/or skin, usually arising over bony prominences, caused by pressure alone, or by a combination of shear and pressure. subcutaneous tissue damage. Pressure ulcer is a painful, costly and preventable health problem that is frequently encountered especially in geriatrics group and in patients with limited daily activities or bedridden. It is an undesirable health care problem that is difficult to treat, but it is possible to prevent the development of pressure ulcers with the measures to be taken from the beginning of the disease. In order for nurses to fulfill their role in preventing pressure ulcers, the content of undergraduate education programs needs to be arranged in a way that will provide them with knowledge and skills in the prevention of pressure ulcers, diagnosis of risky patients and maintenance of care. In Northern Cyprus, knowledge and skills related to pressure sores are provided to students in the basic nursing education curriculum. However, the subject of pressure ulcer in the education programs of nursing schools differs in terms of content and duration, and most of the hospitals do not have a standard guide and training program for the prevention of pressure ulcers. In Northern Cyprus, studies on the knowledge and practices of nursing students to prevent pressure ulcers are limited. According to the results of a study conducted in Turkey, it has been reported that a significant portion of nursing students have a positive attitude towards preventing pressure ulcers, but their general knowledge about preventing pressure ulcers is insufficient. In another study, it was reported that 70.7% of nursing students encountered patients with pressure ulcers during hospital practices, but research findings and the knowledge of nursing students to prevent the development of pressure ulcers were insufficient. Similarly, in studies conducted with nursing students using different scales, it has been reported that students' knowledge levels about preventing pressure ulcers are low. This research was planned in accordance with the randomized controlled research method in order to determine the knowledge levels and practices of firts year nursing students to prevent pressure ulcers.

NCT ID: NCT05101473 Completed - Diabetic Foot Ulcer Clinical Trials

Exercise Therapy for People With a Diabetic Foot Ulcer - a Feasibility Study

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The aim of this feasibility study is to evaluate a 12-week exercise intervention in people with an active diabetic foot ulcer through pre-defined research progression criteria (participant recruitment and retention, duration of the collection of outcome measures, adherence to the exercise programme, and adverse events), besides participant and physiotherapist feedback, self-reported outcomes and objective measurements in preparation for a potential future RCT. The primary study hypothesis is that exercise therapy for people with an active diabetic foot ulcer will have high participant recruitment and adherence to treatment and that it does not affect wound healing negatively.

NCT ID: NCT05084261 Completed - Ulcerative Colitis Clinical Trials

An Investigation of Oral BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)

SCOUT
Start date: November 30, 2021
Phase: Phase 1
Study type: Interventional

This is a randomised, double-blind, placebo-controlled study to assess the safety and tolerability of multiple ascending doses of BT051 in subjects with moderately to severely active ulcerative colitis. Subjects will be randomised using a 3 active:1 placebo ratio to 3 ascending dose cohorts of 8 subjects and will be dosed daily for 28 days. The 3 initial dose levels will be 200 mg, 800 mg and 3200 mg per day. Progression to the next cohort will be based on the safety and tolerability of the previous cohort.

NCT ID: NCT05082428 Completed - Ulcerative Colitis Clinical Trials

This Study is to Describe and Evaluate Patients in Finland Treated With Tofacitinib for the Treatment of Ulcerative Colitis Using Real World Data.

Start date: May 30, 2022
Phase:
Study type: Observational

The aim of this study is to describe and evaluate clinical outcomes, treatment lines, and to identify the key characteristics of the patients treated with tofacitinib.