Surface NeuroMuscular Electrical Stimulation in the Treatment of Chronic Venous Leg Ulcers: A Randomised Controlled Trial of the "VASGARD" Device
Compression bandaging
+ VASGARD stimulator
+ Compression bandaging
Cardiovascular Diseases+5
+ Skin Diseases
+ Skin Ulcer
Treatment Study
Summary
Study start date: May 1, 2013
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Department of Electronic Engineering, National University Ireland Galway
Galway, IrelandOpen Department of Electronic Engineering, National University Ireland Galway in Google MapsMidWestern Regional Hospital
Limerick, Ireland