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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
  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:


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


Estimated Enrollment: 50
Study Start Date: May 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: March 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

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
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

Contacts
Contact: Mary Clarke Moloney, Ph.D. 0035361482736 ext 2736 mary.clarkemoloney@hse.ie

Locations
Ireland
Department of Electronic Engineering, National University Ireland Galway Not yet recruiting
Galway, Ireland, 000
Contact: Gavin Corley       gavin.corley@nuigalway.ie   
Principal Investigator: Gearoid O Laighin         
Sub-Investigator: Gavin Corley         
Sub-Investigator: Barry Broderick         
MidWestern Regional Hospital Recruiting
Limerick, Ireland, 000
Contact: Mary Clarke Moloney, Ph.D.    0035361482736 ext 2736    mary.clarkemoloney@hse.ie   
Contact: Stewart R Walsh, MCh FRCS    00353876632654    stewart.walsh@ul.ie   
Sub-Investigator: Mary Clarke Moloney, Ph.D.         
Principal Investigator: Pierce A Grace, MCh FRCSI         
Sub-Investigator: Stewart R Walsh, MCh FRCS         
Sponsors and Collaborators
Professor Stewart Walsh
Investigators
Principal Investigator: Pierce A Grace, MCh FRCSI HSE
  More Information

No publications provided

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: January 30, 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
Cardiovascular Diseases
Skin Diseases
Skin Ulcer
Varicose Veins
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014