Head of Department of Physical Therapy for Cardiovascular/Respiratory Disorders and Geriatrics
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 79
- 主要终点
- Blood flow
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• 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).
排除标准
- •• Severe peripheral arterial disease (ABPI <0.5).
- •Active infection requiring hospitalization.
- •History of amputation.
- •Cardiac pacemaker or contraindication to EMF therapy.
结局指标
主要结局
Blood flow
时间窗: Measurement Timeline: • Minimum value (Baseline)(Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12)
Primary Outcome: • Peripheral Circulation: Assessed by Laser Doppler Flowmetry and/or skin perfusion pressure (SPP).
次要结局
- • Ankle-Brachial Pressure Index (ABPI)(Measurement Timeline: • Minimum value (Baseline) (Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12))
- • Ulcer Healing Rate(Measurement Timeline: • Minimum value (Baseline) (Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12))
- • Pain Level:(Measurement Timeline: • Minimum value (Baseline) (Week 0) • Mid-intervention (Week 4) • Maximum value (Post-intervention) (Week 8) • Follow-up (Week 12))
研究者
Ibrahim Abuzaid
Ibrahim ismail Abuzaid
South Valley University