Effect of Electromagnetic Field Therapy and Customized Foot Insole on Peripheral Circulation and Ankle-Brachial Pressure Index in Patients With Diabetic Foot Ulcer

Официальное название

Head of Department of Physical Therapy for Cardiovascular/Respiratory Disorders and Geriatrics

Обзор

Diabetic foot ulcers (DFUs) are a significant complication of diabetes mellitus, associated with poor peripheral circulation, neuropathy, and increased risk of lower-limb amputation. Optimizing peripheral blood flow is critical in the prevention and management of DFUs. Traditional offloading strategies, such as customized foot insoles, have demonstrated efficacy in reducing plantar pressure and promoting ulcer healing. Electromagnetic field (EMF) therapy is a non-invasive modality that has shown potential in enhancing microcirculation, promoting angiogenesis, and modulating inflammatory processes. Preliminary studies have suggested that EMF may improve peripheral circulation and tissue oxygenation in diabetic patients. This study aims to investigate the combined effect of EMF therapy and customized foot insoles on peripheral circulation and Ankle-Brachial Pressure Index (ABPI) in patients with diabetic foot ulcers, hypothesizing that this integrated approach may yield superior outcomes compared to standard care.

Подробное описание

2\. Objectives

Primary Objective:

• To evaluate the effect of EMF therapy combined with customized foot insoles on peripheral circulation in patients with diabetic foot ulcers.

Secondary Objective:

* To assess changes in Ankle-Brachial Pressure Index (ABPI) following intervention. * To compare the ulcer healing rates and pain levels between intervention and control groups.

3\. Research Questions 1. Does the combination of EMF therapy and customized foot insoles improve peripheral circulation in patients with diabetic foot ulcers? 2. Is there a significant improvement in ABPI in the intervention group compared to control? 3. What is the effect of the intervention on ulcer healing rates and pain reduction?

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ 4. Hypotheses * H1: EMF therapy combined with customized foot insoles significantly improves peripheral circulation compared to standard care. * H2: EMF therapy combined with customized foot insoles significantly improves ABPI in patients with diabetic foot ulcers.

Вмешательства

• Устройство Electromagnetic Field Therapy: • Frequency: 50 Hz • Intensity: 5-30 mT • Duration: 30 minutes/session • Frequency: 3 sessions/week for 8 weeks Customized Foot Insoles: • Individually tailored based on
  Electromagnetic Field Therapy: * Frequency: 50 Hz * Intensity: 5-30 mT * Duration: 30 minutes/session * Frequency: 3 sessions/week for 8 weeks Customized Foot Insoles: * Individually tailored based on foot pressure mapping and deformity. * Designed to offload pressure points and support foot arches. Standard Care: • Wound care, glycemic control, and patient education as per institutional protocol.

Первичные конечные точки

• Blood flow [Срок оценки: Measurement Timeline: • Minimum value (Baseline)(Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12)]

Вторичные конечные точки (3)

• • Ankle-Brachial Pressure Index (ABPI) [Срок оценки: Measurement Timeline: • Minimum value (Baseline) (Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12)]
• • Ulcer Healing Rate [Срок оценки: Measurement Timeline: • Minimum value (Baseline) (Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12)]
• • Pain Level: [Срок оценки: Measurement Timeline: • Minimum value (Baseline) (Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12)]

Критерии участия

Критерии включения

• • Diagnosed with Type 2 Diabetes Mellitus.

• Presence of unilateral or bilateral diabetic foot ulcer.
• ABPI between 0.6 - 1.0 (mild to moderate arterial insufficiency).

Критерии исключения

• • Severe peripheral arterial disease (ABPI <0.5).

• Active infection requiring hospitalization.
• History of amputation.
• Cardiac pacemaker or contraindication to EMF therapy.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Burhan A, Arofiati F, Da Silva VA, Sebayang SM. Effect of Ankle Brachial Index (ABI) and Compression Therapy on Diabetic Foot Ulcer Healing. Curr Diabetes Rev. 2024;20(1):e310323215277. doi: 10.2174/1573399819666230331083420. PMID 37005544

Идентификаторы

NCT: NCT07070544 · South Valley University PTh

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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