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

Chronic Venous Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801891
• Other study ID #: VASGARD2013
• Status: Completed
• Phase: Phase 2
• First received: February 25, 2013
• Last updated: December 11, 2014
• Start date: May 2013
• Est. completion date: October 2014

Study information

• Verified date: December 2014
• Source: Mid Western Regional Hospital, Ireland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Venous Disease
• Leg Ulcer
• Varicose Ulcer

Intervention

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:
• 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.

Locations

Country	Name	City	State
Ireland	Department of Electronic Engineering, National University Ireland Galway	Galway
Ireland	MidWestern Regional Hospital	Limerick

Sponsors (1)

Lead Sponsor	Collaborator
Professor Stewart Walsh

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Primary	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	No
Secondary	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	No