Surface NeuroMuscular Electrical Stimulation in the Treatment of Chronic Venous Leg Ulcers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Venous Disease

Intervention / Treatment
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* Device: VASGARD stimulator
* Other: Compression bandaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br>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. | Other: Compression bandaging<br>* 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.<br>* Other names: Graduated compression bandaging;|
| Experimental: VASGARD stimulator<br>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. | Device: VASGARD stimulator<br>* 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.<br>* Other names: SNMES;Other: Compression bandaging<br>* 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.<br>* Other names: Graduated compression bandaging;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in venous ulcer size | Reduction in relative ulcer size (area) for each patient over time, standardised to an initial size of 1, will be measured weekly. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of surface neuromuscular electrical stimulation | Patient and healthcare provider perceptions of the acceptability, efficacy and tolerability of the device will be evaluated through a series of semi-structured interviews | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Venous ulceration, Leg ulcers, Venous haemodynamics, Surface neuromuscular electrical stimulation, SNMES