Effect of Magnetic Current on Ulcer Healing

Официальное название

Effect of Magnetic Current on Chronic Ulcer Healing of Diabetic Foot

Обзор

This study aims to evaluate the effectiveness of magnetic current in the management of DFUs as an alternative therapy on promoting the healing of chronic diabetic foot ulcers as compared with a control group.Twenty diabetic patients (n=40) affected with diabetic foot ulcer(s) will be recruited in the study and will be randomly allocated into two equal groups (20 patients in each group): 1- Group A: Pulsed electromagnetic field (PEMF) group. 2- Group B: Control group. Assessments of the healing of ulcers will be performed at the baseline, post-treatment evaluation (ie, after 14 treatment sessions), and 1-month follow-up. :

Подробное описание

This study aims to evaluate the effectiveness of magnetic current in the management of DFUs as an alternative therapy on promoting the healing of chronic diabetic foot ulcers as compared with a control group.Twenty diabetic patients (n=40) affected with diabetic foot ulcer(s) will be recruited in the study and will be randomly allocated into two equal groups (20 patients in each group):

1. Group A: Pulsed electromagnetic field (PEMF) group. 2. Group B: Control group. Assessments of the healing of ulcers will be performed at the baseline, post-treatment evaluation (ie, after 14 treatment sessions), and 1-month follow-up.

Outcome measures will include:

1. Wound closure. 2. Wound depth. 3. Microcirculation.

Вмешательства

• Устройство pulsed electromagnetic currant machine
  Pulsed electromagnetic therapy will be delivered at the frequency of 12Hz, with magnetic flux density of 12G. Each treatment session will last for 1 hour, which will be repeated for 14 sessions within 4weeks.
• Другое Placebo
  control group will receive intervention by using the same PEMF unit, but the output will be shut off.

Первичные конечные точки

• ulcer size [Срок оценки: 4 weeks]
• Doppler ultrasonography [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• 1\. The ankle brachial index should fall between 0.9 and 1.2 to reassure that arterial insufficiency was not causing or contributing to the nonhealing wound.

2\. Patients diagnosed with diabetes with unsatisfactory healing of ulcer(s) in the preceding 4 weeks.

3\. Wagner grade 1 or 2 ulcers on the foot without exposure of bone, muscle, ligaments, or tendons.

Критерии исключения

\- 1- Ulcers secondary to non-diabetic etiology. 2- Poorly controlled diabetes. 3- Pregnancy. 4- Patients wearing a pacemaker or with malignancy or history of radiotherapy. 5- Patients who were taking medications that might affect their circulation or sensation and motor functioning and patients with any history of alcoholism were also excluded.

6- Patients who had clinical signs of infection or were taking antibiotics at the time of enrollment.

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

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Beni-Suif University Hospital — Cairo

Публикации

• Kwan RL, Cheing GL, Vong SK, Lo SK. Electrophysical therapy for managing diabetic foot ulcers: a systematic review. Int Wound J. 2013 Apr;10(2):121-31. doi: 10.1111/j.1742-481X.2012.01085.x. Epub 2012 Sep 7. PMID 22958779

Идентификаторы

NCT: NCT06808191 · FMBSUREC/03032024/Kamel

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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