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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Venous Disease
• Intervention / Treatment: Other: Compression bandaging; Device: VASGARD stimulator

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• Ireland
  • Galway, Ireland, 000
    • Department of Electronic Engineering, National University Ireland Galway
  • Limerick, Ireland, 000
    • Midwestern Regional Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Compression bandaging; 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.; Other Names: Graduated compression bandaging
Experimental: 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.	Other: Compression bandaging; 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.; Other Names: Graduated compression bandaging; Device: VASGARD stimulator; 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.; Other Names: SNMES

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in skin condition related to the application of Vasgard surface neuromuscular electrical stimulator as a measure of safety and tolerability.	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.; Appearance of the skin under the electrodes (intact / reddened / broken); Appearance of skin surrounding the electrodes (intact / reddened /broken); Appearance of skin under the electrodes leads (intact / reddened / broken	12 weeks

Collaborators and Investigators

• Sponsor: Professor Stewart Walsh
• Investigators: Principal Investigator: Pierce A Grace, MCh FRCSI, HSE

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: February 25, 2013
• First Submitted That Met QC Criteria: February 27, 2013
• First Posted (Estimate): March 1, 2013

Study Record Updates

• Last Update Posted (Estimate): December 12, 2014
• Last Update Submitted That Met QC Criteria: December 11, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Venous ulceration; Leg ulcers; Venous haemodynamics; Surface neuromuscular electrical stimulation; SNMES
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: VASGARD2013

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No