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临床试验/NCT01801891
NCT01801891已完成2 期

Surface NeuroMuscular Electrical Stimulation in the Treatment of Chronic Venous Leg Ulcers: A Randomised Controlled Trial of the "VASGARD" Device

Professor Stewart Walsh4 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2013年5月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
25
试验地点
4
主要终点
Reduction in venous ulcer size

研究概览

简要总结

This study aims to determine if the use of surface neuromuscular electrical stimulation, applied to various motor points on the lower limb to elicit muscle contraction when combined with compression bandaging accelerates the rate of venous leg ulcer healing.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Reduction in venous ulcer size

时间窗: 12 weeks

Reduction in relative ulcer size (area) for each patient over time, standardised to an initial size of 1, will be measured weekly.

次要结局

  • Acceptability of surface neuromuscular electrical stimulation(12 weeks)

研究者

发起方
Professor Stewart Walsh
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Professor Stewart Walsh

Professor Stewart Walsh

Mid Western Regional Hospital, Ireland

研究点 (4)

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