Chronic Venous DiseasePhase 2NCT01801891
Surface NeuroMuscular Electrical Stimulation in the Treatment of Chronic Venous Leg Ulcers
A Phase 2 study testing VASGARD stimulator and Compression bandaging in people with Chronic Venous Disease, run by Professor Stewart Walsh at 2 sites in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Venous Disease
- What is being tested?
- VASGARD stimulator and Compression bandaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesIreland
- Study dates
- May 2013to Oct 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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 locations and contacts
2 sites in 1 country.
Ireland2 sites
Department of Electronic Engineering, National University Ireland Galway
Galway, 000
MidWestern Regional Hospital
Limerick, 000
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Venous Disease
- Being tested
- VASGARD stimulator, Compression bandaging
- Keywords
- Venous ulceration, Leg ulcers, Venous haemodynamics, Surface neuromuscular electrical stimulation, SNMES
- Medical subject headings
- Varicose Ulcer, Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VASGARD stimulatorDevice
Also called SNMES
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.
Compression bandagingOther
Also called Graduated 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: VASGARD stimulator; Other: Compression bandaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
Acceptability of surface neuromuscular electrical stimulation
Patient and healthcare provider perceptions of the acceptability, efficacy and tolerability of the device will be evaluated through a series of semi-structured interviews
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Venous DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Stewart Walsh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Professor Stewart Walsh, Mid Western Regional Hospital, Ireland
- Investigators
- Pierce A Grace, MCh FRCSI, Principal investigator, HSE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801891
- Sponsor's protocol ID
- VASGARD2013
- Status last verified
- Dec 2014
- First submitted
- 25 Feb 2013
- Last updated
- 12 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surface NeuroMuscular Electrical Stimulation in the Treatment of Chronic Venous Leg Ulcers: A Randomised Controlled Trial of the "VASGARD" Device
- ClinicalTrials.gov ID
- NCT01801891
- Acronym / sponsor ID
- VASGARD2013
- Conditions
- Chronic Venous Disease
- Keywords
- Venous ulceration, Leg ulcers, Venous haemodynamics, Surface neuromuscular electrical stimulation, SNMES
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Professor Stewart WalshUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 1 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Compression bandagingPatients 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. |
| VASGARD stimulator | Experimental | Device: VASGARD stimulator, Other: Compression bandagingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VASGARD stimulatorAlso: SNMESThe 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. | Device | VASGARD stimulator |
| Compression bandagingAlso: Graduated compression bandagingCompression 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 | Control group, VASGARD stimulator |
Primary outcome
Reduction in venous ulcer size
Time frame: 12 weeks
Reduction in relative ulcer size (area) for each patient over time, standardised to an initial size of 1, will be measured weekly.
1 secondary outcome
Acceptability of surface neuromuscular electrical stimulation
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierce A Grace, MCh FRCSI principal investigator
HSE
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VASGARD stimulator and Compression bandaging in people with Chronic Venous Disease, run by Professor Stewart Walsh at 2 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in venous ulcer size (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2014.