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

Professor Stewart Walsh

Status and phase: Completed; Phase 2

Conditions: Chronic Venous Disease

Treatments: Device: VASGARD stimulator; Other: Compression bandaging

Study type: Interventional

Funder types: Other

Identifiers

NCT01801891

VASGARD2013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups

Control group

Active Comparator group

Description:

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.

Treatment:

Other: Compression bandaging

VASGARD stimulator

Experimental group

Description:

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.

Treatment:

Other: Compression bandaging

Device: VASGARD stimulator