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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Mid Western Regional Hospital, Ireland
Sponsor:
Information provided by (Responsible Party):
Professor Stewart Walsh, Mid Western Regional Hospital, Ireland
ClinicalTrials.gov Identifier:
NCT01801891
First received: February 25, 2013
Last updated: January 30, 2014
Last verified: January 2014

February 25, 2013
January 30, 2014
May 2013
March 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01801891 on ClinicalTrials.gov Archive Site
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
Same as current
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
Same as current
 
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Venous Disease
  • 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
  • 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.
    Intervention: Other: 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.
    Interventions:
    • Device: VASGARD stimulator
    • Other: Compression bandaging
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
May 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Mary Clarke Moloney, Ph.D. 0035361482736 ext 2736 mary.clarkemoloney@hse.ie
Ireland
 
NCT01801891
VASGARD2013
Yes
Professor Stewart Walsh, Mid Western Regional Hospital, Ireland
Professor Stewart Walsh
Not Provided
Principal Investigator: Pierce A Grace, MCh FRCSI HSE
Mid Western Regional Hospital, Ireland
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP