Effect of Insulin Therapy by Ultrasonography in Wound Healing of Chronic Diabetic Patients

Официальное название

Effect of Transdermal Insulin Therapy by Ultrasonographic in Wound Healing of Chronic Diabetic Patients

Обзор

The main aim of the study is to determine the effect of transdermal application of insulin therapy by phonophoresis in wound healing in diabetic patients the main question of the study: is insulin phonophoresis is effective in accelerating healing in patients with diabetes mellites? 40 patients will be randomly assigned to two groups group A will receive insulin phonophoresis plus hyper polarized laser therapy and standard wound cleaning and dressing three times weekly over four weeks. Group B will receive hyper polarized laser therapy and standard wound cleaning and dressing three times weekly over four weeks.

Подробное описание

DIMST scale ( as an acronym from the initial domains of depth, maceration, inflammation/infection, size, tissue type of the wound bed, type of wound edge, and tunneling/undermining) will be used for assessment.

MANOVA will be used for statistical analysis between group comparison

Вмешательства

• Другое Insulin therapy phonophoresis
  Insulin therapy phonophoresis is the use of ultrasound to deliver drugs through patients skin, Insulin therapy will be used to determine its effect on wound healing in patients with chronic diabetes mellites because in addition to its systemic impact, numerous reports suggest that applying insulin topically causes localized effects. Many trials and case reports have been released reporting positive effects of topical insulin for many diseases such as dermatological compromises, ophthalmological
• Другое Hyperpolarized light therapy and Standard wound cleaning and dressing.
  Hyperpolarized light therapy safely accelerates wound healing by stimulating blood circulation, reducing inflammation and relieving muscle spasms.

Первичные конечные точки

• DMIST scale which is a valid and reliable scale for measuring depth, maceration, inflammation/infection, size, tissue type of the wound bed, type of wound edge, and tunneling/undermining. [Срок оценки: before first session and at the end of the treatment program (four weeks)]

Критерии участия

Критерии включения

• patients will be included if they are free from any pathological condition like limb infection, local or proximate malignancy, and anti-coagulated patients.

Критерии исключения

patients will be excluded if they have any pathological condition like limb infection, local or proximate malignancy, and anti-coagulated patients.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06708975 · P.T.REC/012/005342

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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