NCT01801891

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

December 12, 2014

Status Verified

December 1, 2014

Enrollment Period

1.3 years

First QC Date

February 25, 2013

Last Update Submit

December 11, 2014

Conditions

Chronic Venous Disease

Keywords

Venous ulcerationLeg ulcersVenous haemodynamicsSurface neuromuscular electrical stimulationSNMES

Outcome Measures

Primary Outcomes (1)

  • Reduction in venous ulcer size

    Reduction in relative ulcer size (area) for each patient over time, standardised to an initial size of 1, will be measured weekly.

    12 weeks

Secondary Outcomes (1)

  • Acceptability of surface neuromuscular electrical stimulation

    12 weeks

Other Outcomes (1)

  • Changes in skin condition related to the application of Vasgard surface neuromuscular electrical stimulator as a measure of safety and tolerability.

    12 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

VASGARD stimulator

EXPERIMENTAL

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 stimulatorOther: Compression bandaging

Interventions

VASGARD stimulatorDEVICE

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.

Also known as: SNMES
VASGARD stimulator
Compression bandagingOTHER

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.

Also known as: Graduated compression bandaging
Control groupVASGARD stimulator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Electronic Engineering, National University Ireland Galway

Galway, 000, Ireland

Location

MidWestern Regional Hospital

Limerick, 000, Ireland

Location

MeSH Terms

Conditions

Varicose UlcerLeg Ulcer

Interventions

Compression Bandages

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BandagesEquipment and Supplies

Study Officials

  • Pierce A Grace, MCh FRCSI

    HSE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Stewart Walsh

Study Record Dates

First Submitted

February 25, 2013

First Posted

March 1, 2013

Study Start

May 1, 2013

Primary Completion

September 1, 2014

Study Completion

October 1, 2014

Last Updated

December 12, 2014

Record last verified: 2014-12

Locations

IE(2)