Surface NeuroMuscular Electrical Stimulation in the Treatment of Chronic Venous Leg Ulcers
Surface NeuroMuscular Electrical Stimulation in the Treatment of Chronic Venous Leg Ulcers: A Randomised Controlled Trial of the "VASGARD" Device
研究概览
详细说明
With an increasingly ageing population the incidence of venous ulceration is likely to rise. The negative impact of leg ulceration on patients' quality of life and on healthcare costs is well recognised. Increased prevalence combined with poor reported healing rates and high incidence of ulcer recurrence makes the development of a new treatment which could accelerate healing rates beyond that currently achieved using compression bandaging most desirable. Surface neuromuscular electrical stimulation in combination with compression bandaging may provide such a treatment.
Surface neuromuscular electrical stimulation (SNMES) is the application of an electrical stimulus to motor points in the body using electrodes placed on the surface of the skin to elicit a muscular contraction. It has been shown that SNMES of the calf muscles, when used in conjunction with compression therapy, provides improved venous flow velocities over compression therapy alone. Furthermore, the week-long effect of SNMES and compression therapy on healthy participants was found to be well tolerated by all participants and resulted in increases in stimulated venous flow and muscle strength. A combined SNMES and compression treatment protocol which stimulates peripheral venous blood flow may help to alleviate harmful venous pressures in venous leg ulcer patients and provide some degree of strengthening of the calf muscles, thus helping to accelerate the healing rates of venous ulcers.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Galway、爱尔兰、000
- Department of Electronic Engineering, National University Ireland Galway
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Limerick、爱尔兰、000
- Midwestern Regional Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Primary or recurrent venous leg ulcer.
- Ankle-brachial pressure index > 0.8
- Ulcer size between 1 and 200 cm2
- Patient suitable for full compression bandaging
Exclusion Criteria:
- History of symptomatic heart disease.
- Pregnancy
- Presence of implants in the lower leg or a pacemaker
- History of a neurological disorder
- Presence of any contraindications for the use of compression stockings such as severe arterial disease i.e. Ankle brachial pressure index (ABPI) <0.8
- Presence of cognitive difficulties which may prevent the patient or his/her carer from using the stimulator appropriately.
- Patients unable to provide informed consent
- Patients receiving dialysis
- Patients receiving steroids
- Patients receiving methotrexate
- Ulcer located in the area of electrode placement
- Patients in reduced compression bandaging system
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：Control group
Patients randomised to the control group will, in addition to their routine compression bandaging, be given muscle stimulators for home use and instructed to apply 3x 30 minute sessions of comfortable electrical stimulation daily for 12 weeks.
The stimulators given to the control group will be set to provide minimal stimulation resulting in no visible muscular contraction.
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Compression bandaging systems apply graduated external pressure to the lower limb to promote venous return to the heart reducing venous hypertension and thereby facilitate venous ulcer healing.
其他名称：
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实验性的：VASGARD stimulator
Patients randomised to this group, in addition to their routine treatment with compression bandaging, will be given muscle stimulators for home use and instructed to apply 3x 30 minute sessions of comfortable electrical stimulation daily for 12 weeks.
The intervention group stimulators will be capable of causing muscular contraction with a maximum force ranging from 30-40% of voluntary contractions.
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Compression bandaging systems apply graduated external pressure to the lower limb to promote venous return to the heart reducing venous hypertension and thereby facilitate venous ulcer healing.
其他名称：
The VASGARD device is a 2 channel muscle stimulator system designed for increasing venous blood flow.
Controlled electrical stimuli are delivered to the patient through adhesive gel electrodes placed over the motor points of muscles on the lower leg.
This elicits artificial muscular contractions which in turn increases lower limb venous haemodynamics.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Reduction in venous ulcer size
大体时间：12 weeks
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Reduction in relative ulcer size (area) for each patient over time, standardised to an initial size of 1, will be measured weekly.
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12 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Acceptability of surface neuromuscular electrical stimulation
大体时间：12 weeks
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Patient and healthcare provider perceptions of the acceptability, efficacy and tolerability of the device will be evaluated through a series of semi-structured interviews
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12 weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in skin condition related to the application of Vasgard surface neuromuscular electrical stimulator as a measure of safety and tolerability.
大体时间：12 weeks
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The safety issues associated with using electrical stimulation on this patient group under compression bandaging will be evaluated. The following safety points will be evaluated at each visit.
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12 weeks
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合作者和调查者
调查人员
- 首席研究员：Pierce A Grace, MCh FRCSI、HSE
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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