Surface NeuroMuscular Electrical Stimulation in the Treatment of Chronic Venous Leg Ulcers - Full Text View

Purpose

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.

Condition	Intervention	Phase
Chronic Venous Disease	Device: VASGARD stimulator Other: Compression bandaging	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Surface NeuroMuscular Electrical Stimulation in the Treatment of Chronic Venous Leg Ulcers: A Randomised Controlled Trial of the "VASGARD" Device

Resource links provided by NLM:

MedlinePlus related topics: Leg Injuries and Disorders

U.S. FDA Resources

Further study details as provided by Mid Western Regional Hospital, Ireland:

Primary Outcome Measures:

Reduction in venous ulcer size [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Reduction in relative ulcer size (area) for each patient over time, standardised to an initial size of 1, will be measured weekly.

Secondary Outcome Measures:

Acceptability of surface neuromuscular electrical stimulation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Patient and healthcare provider perceptions of the acceptability, efficacy and tolerability of the device will be evaluated through a series of semi-structured interviews

Other Outcome Measures:

Changes in skin condition related to the application of Vasgard surface neuromuscular electrical stimulator as a measure of safety and tolerability. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
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.
1. Appearance of the skin under the electrodes (intact / reddened / broken)
2. Appearance of skin surrounding the electrodes (intact / reddened /broken)
3. Appearance of skin under the electrodes leads (intact / reddened / broken


Enrollment:	25
Study Start Date:	May 2013
Study Completion Date:	October 2014
Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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.	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 Name: SNMES 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 Name: Graduated compression bandaging

Arms

Assigned Interventions

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 Name: 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.

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 Name: SNMES

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 Name: Graduated compression bandaging

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01801891

Locations


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

Sponsors and Collaborators

Professor Stewart Walsh

Investigators


Principal Investigator:	Pierce A Grace, MCh FRCSI	HSE

More Information


Responsible Party:	Professor Stewart Walsh, Mid Western Regional Hospital, Ireland
ClinicalTrials.gov Identifier:	NCT01801891 History of Changes
Other Study ID Numbers:	VASGARD2013
Study First Received:	February 25, 2013
Last Updated:	December 11, 2014
Health Authority:	Ireland: Research Ethics Committee

Keywords provided by Mid Western Regional Hospital, Ireland:


Venous ulceration Leg ulcers Venous haemodynamics Surface neuromuscular electrical stimulation SNMES

Additional relevant MeSH terms:


Leg Ulcer Varicose Ulcer Skin Ulcer Skin Diseases	Varicose Veins Vascular Diseases Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 28, 2016