Clinical trial NCT01801891: Surface NeuroMuscular Electrical Stimulation in the Treatment of Chronic Venous Leg Ulcers
Official title: Surface NeuroMuscular Electrical Stimulation in the Treatment of Chronic Venous Leg Ulcers: A Randomised Controlled Trial of the "VASGARD" Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Venous Disease
Keywords: Venous ulceration
Leg ulcers
Venous haemodynamics
Surface neuromuscular electrical stimulation
SNMES
Lead sponsor: Mid Western Regional Hospital, Ireland
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Reduction in venous ulcer size
timeFrame: 12 weeks
Secondary outcomes:
measure: Acceptability of surface neuromuscular electrical stimulation
timeFrame: 12 weeks
Other outcomes:
measure: Changes in skin condition related to the application of Vasgard surface neuromuscular electrical stimulator as a measure of safety and tolerability.
timeFrame: 12 weeks
Locations:
city: Galway
country: Ireland
facility: Department of Electronic Engineering, National University Ireland Galway
city: Limerick
country: Ireland
facility: MidWestern Regional Hospital
Study officials:
affiliation: HSE
name: Pierce A Grace, MCh FRCSI
role: PRINCIPAL_INVESTIGATOR
References: