Набор скоро начнётся NCT06703762

Efficacy of Photobiomodulation on Wound Healing and Il-6 in Neuropathic Foot Ulcer

Без фазы С лечением Neuropathic Foot Ulcer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: He-Ne low level laser (LLL), Conventional traditional treatment.
Кому может быть актуально: Состояния в реестре: Neuropathic Foot Ulcer. Базовые параметры: 50 лет — 70 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Египет
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The aim of this study is to detect the effect of Laser Photobiomodualation on the wound healing and Il-6 in neuropathic foot ulcer.

Подробное описание

Wound healing is a complex, interactive, and integrative event, involving cellular and chemotactic activity with release of chemical mediators associated with vascular responses and cell proliferation. It consists in a sequence of events leading to the closure of dermal injuries. The repair follows steps of inflammation, re-epithelization, wound contraction, and matrix remodeling. The healing process can be influenced by various local and systemic factors.

The ulcer treatment in the diabetic foot requires a multidisciplinary approach, including revascularization and surgical procedures, as well as the infection treatment, physiotherapeutic rehabilitation with electric phototherapeutic resources to control edema, pain, metabolic disorders, tissue malnutrition, co morbidities, precise treatment of the wound and biomechanics' decompression that will help in amputation prevention.

Biophotomodulation in the form of Low level laser (LLL) irradiation can promote cell migration and cell proliferation by stimulating mitochondrial activity and maintaining viability without causing damage to the wounded cells.

The usage of LLLT presents itself as being a new therapeutic proposal, seeking the cure of these injuries, the improvement on the quality of life of the affected individuals, as well as the reduction of the costs of the treatment in the health system, this study aims to identify the effects of low-level laser therapy on neuropathic foot ulcer healing and the effect of LLL on the hyperglycemic-induced inflammatory response in IL-6 and sought to identify which pathway it might achieve this effect.

Вмешательства

Другое He-Ne low level laser (LLL)
Patients in the experimental group will receive treatment with LLLT. The ulcer bed will be irradiated locally with red light (660 nm). The ulcer size and its depth will be used as the basis to calculate the duration of exposure needed to deliver 3-10 J/cm² for 15 to 20 minutes. The application will take place in 3 sessions per week for 4 weeks. Each patient will be asked to lie in a supine position with the ulcer easily exposed to the laser beam, and they will be instructed to wear laser glasses
Другое Conventional traditional treatment
All patients in both the groups will receive the required, conventional treatments of diabetic wound care, including dressing, antibiotics, controlling diabetes, cholesterol, and blood pressure along with aggressive drug treatment and wound debridement when needed.

Первичные конечные точки

Measurement of Ulcer Length [Срок оценки: 4 weeks]
Measurement of Ulcer Width [Срок оценки: 4 weeks]
Measurement of Ulcer Area [Срок оценки: 4 weeks]
Measurement of volume of the ulcer [Срок оценки: 4 weeks]
Assessment of serum IL-6 level [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

All patient will be diagnosed with neuropathic foot ulcer.
All patient diagnosed as type II Diabetes Mellitus.
Wound size a 6-12 cm2.
Diabetic ulcers will be in grade 2 and 3 (Partial thickness skin loss involving epidermis and or dermis (superficial, abrasion, blister, and / or full thickness skin loss damage ore necrosis of subcutaneous tissue may extend down to but not through underlying fascia.