A Phase IV Clinical Trial. Effect of Pulsing Electromagnetic Fields on Lower Extremity Diabetic Neuropathy: A Pilot, Open-Label Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- MedRelief
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Pain reduction in diabetic patients with chronic diabetic neuropathy
研究概览
简要总结
To determine if pulsed electric field therapy reduces lower leg and foot pain associated with diabetic neuropathy and lessens the need for medication.
The MedRelief device sends a sub-threshold electric signal through the skin using electrodes as means of signal delivery. The signal or waveform, frequency and strength were created to match the characteristics of signals the body generates to help natural healing.
详细描述
A multi-center, randomized, open-label study involving 23 patients with chronic diabetic peripheral neuropathy meeting study entry criteria. Subjects will be randomly assigned to receive one of two treatments using an FDA cleared MedRelief device: (1) a MedRelief SE 55 device set on "pulsed" mode at 10 microsecond burst intervals 4150 Ha, or (2) a MedRelief SE 55 device set on "continuous" mode at 4150 Hz. Subjects will wear the device on target foot each night for a minimum of 6 hours over a two week (15 day treatment)period.
Subjects will complete a daily pain diary, medication form, and device use form. Subject global assessments and physician global assessments will occur at baseline, study visits Day 7, Day 15 and Day 21 (end of study).
Response to therapy will include pain reduction, improvement in sensation, improved response to vibratory stimulation and reduction of edema in study subjects.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •currently diagnosed with diabetes mellitus
- •confirmed diagnosis of diabetic peripheral neuropathy
- •age 18 years to 75 years
- •both males and females are eligible for study participation
- •HgA1c level under 9
- •Physician confirmed stable glycemic control for 3 months prior to enrollment
- •baseline pain level over previous month of 5
- •willing to sign IRB approved consent and follow study visit requirements
- •if female of childbearing age willing to undergo urine pregnancy test
排除标准
- 未提供
研究组 & 干预措施
1, 2
- Pulse MedRelief SE 55
- Continuous MedRelief SE 55
干预措施: MedRelief SE 55 (Device)
结局指标
主要结局
Pain reduction in diabetic patients with chronic diabetic neuropathy
时间窗: Day 21
次要结局
- Improvement in sensation and overall foot condition(Day 21)