Chronic Venous DiseaseVeINSNCT02137499

Venous Insufficiency and Neuromuscular Stimulation

A study testing geko device in people with Chronic Venous Disease and Venous Insufficiency, run by Imperial College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The investigators will be evaluating the immediate and longer term effect of treatment with a medical device on the symptoms of chronic venous disease. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Chronic Venous Disease, Venous Insufficiency, Deep Venous Obstruction
What is being tested?: geko device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited Kingdom
Study dates: Aug 2013to Jul 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Exclusion criteria - Heart/lung/kidney failure, pregnancy, diagnosis of peripheral vascular disease, previous VTE, ABPI<0.9, active infection, previous leg fracture or metal implant in leg
Group 2
Inclusion criteria - 18+ years old, 17<BMI<30, clinical diagnosis of superficial venous insufficiency (CEAP C2-6) confirmed with duplex US
Exclusion criteria - Heart/lung/kidney failure, pregnancy, ABPI<0.9, active infection, previous leg fracture or metal implant in leg
Group 3
Inclusion criteria - 18+ years old, 17<BMI<30, clinical diagnosis of deep venous insufficiency (CEAP C2-6) confirmed with duplex US

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Exclusion criteria - Heart/lung/kidney failure, pregnancy, ABPI<0.9, active infection, previous leg fracture or metal implant in leg
Group 4
Inclusion criteria - 18+ years old, 17<BMI<30, clinical diagnosis of deep venous obstruction confirmed with duplex US
Exclusion criteria - Heart/lung/kidney failure, pregnancy, ABPI<0.9, active infection, previous leg fracture or metal implant in leg

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Charing Cross Hospital
Hammersmith, London, W6 8RF

Other trials in United Kingdom

About this study

The investigators will be evaluating the immediate and longer term effect of treatment with a medical device on the symptoms of chronic venous disease.

Read the detailed description

STUDY AIMS

To obtain ultrasound blood flow and velocity measurements in the leg to compare the hemodynamic profiles obtained using a neuromuscular stimulation device with those obtained at rest.
To ascertain if a 6 week protocol of electrical neurostimulation of the muscle pumps in the leg and foot can reduce clinical symptoms and improve quality of life.

METHODS Controlled interventional trial. Group 1 (10 subjects) will be healthy subjects with no clinical venous disease. Subjects with venous incompetence to be recruited into one of three groups. Group 2 (10 subjects) will have superficial venous incompetence; Group 3 (10 subjects) will have deep venous incompetence; Group 4 (10 subjects) will have deep vein occlusion. These will be clinical diagnoses confirmed with duplex ultrasound.

The device used in this study will be the geko™ T-1 device (Firstkind Ltd, UK). A geko™ device will be fitted to each leg. The device stimulation level is set to the minimum level that can achieve the desired response (outward and upward twitching of the foot when raised from the ground).

ENDPOINTS Primary end-point

Increase in venous flow Secondary end points
Improvement in clinical symptoms at 6 weeks, as judged by questionnaire
Reduction in absolute leg diameter and volume at 6 weeks

Conditions: Chronic Venous Disease, Venous Insufficiency, Deep Venous Obstruction
Being tested: geko device
Keywords: Deep venous obstruction, Venous insufficiency
Medical subject headings: Venous Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

geko deviceDevice
Small transcutaneous electrical stimulator. Manufactured in UK by Firstkind UK Ltd, and licensed for use in humans

Study groups in NCT02137499
Study group	Role	What they receive
Healthy subjects	Active comparator	Healthy subjects, free from vascular disease Receives: Device: geko device
Superficial venous insufficiency	Experimental	Clinically symptomatic and ultrasound evidence of superficial venous insufficiency Receives: Device: geko device
Deep venous insufficiency	Experimental	Clinically symptomatic and ultrasound evidence of deep venous insufficiency Receives: Device: geko device
Deep venous obstruction	Experimental	Clinically symptomatic and ultrasound evidence of deep venous obstruction Receives: Device: geko device

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage Change of Haemodynamic Flow
Doppler ultrasound measurements of femoral venous blood flow. The volume flow rate in blood vessel can be calculated by multiplying the cross-sectional area of the blood vessel by the mean velocity of the blood within it.
Measured: baseline, 20 minutes

Secondary outcomes (2)

Improvement in Venous Symptoms
Clinical symptoms will be measured using questionnaires (AVVQ, VCSS)
Measured: 6 weeks
Leg Volume
Measured using ankle and calf circumference, and multiplying using "inverted cone" method
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Jul 2014

First posted13 May 2014 (estimated)
Study startAug 2013
Primary completionJul 2014
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Venous DiseaseStudies of the same condition, open and under way.
More trials run by Imperial College LondonThe sponsor's other registered studies.
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 N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02137499
Sponsor's protocol ID: 13/WM/0027
Other IDs: CR02072
Acronym: VeINS
Status last verified: Oct 2019
First submitted: 12 May 2014
Last updated: 25 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Williams KJ, Moore HM, Ellis M, Davies AH. Pilot Trial of Neuromuscular Stimulation in Human Subjects with Chronic Venous Disease. Vasc Health Risk Manag. 2021 Dec 1;17:771-778. doi: 10.2147/VHRM.S320883. eCollection 2021.
PubMed 34880620

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Venous Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Venous Insufficiency and Neuromuscular Stimulation
ClinicalTrials.gov ID: NCT02137499
Acronym / sponsor ID: VeINS / 13/WM/0027
Conditions: Chronic Venous Disease, Venous Insufficiency, Deep Venous Obstruction
Keywords: Deep venous obstruction, Venous insufficiency
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Imperial College LondonUniversity, hospital or other
Study start: Aug 2013 (actual)
Primary completion: Jul 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 13 May 2014 (estimated)
Results: Posted 11 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The investigators will be evaluating the immediate and longer term effect of treatment with a medical device on the symptoms of chronic venous disease.

Detailed description

STUDY AIMS

To obtain ultrasound blood flow and velocity measurements in the leg to compare the hemodynamic profiles obtained using a neuromuscular stimulation device with those obtained at rest.
To ascertain if a 6 week protocol of electrical neurostimulation of the muscle pumps in the leg and foot can reduce clinical symptoms and improve quality of life.

ENDPOINTS Primary end-point

Increase in venous flow Secondary end points
Improvement in clinical symptoms at 6 weeks, as judged by questionnaire
Reduction in absolute leg diameter and volume at 6 weeks

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Healthy subjects	Active comparator	Device: geko deviceHealthy subjects, free from vascular disease
Superficial venous insufficiency	Experimental	Device: geko deviceClinically symptomatic and ultrasound evidence of superficial venous insufficiency
Deep venous insufficiency	Experimental	Device: geko deviceClinically symptomatic and ultrasound evidence of deep venous insufficiency
Deep venous obstruction	Experimental	Device: geko deviceClinically symptomatic and ultrasound evidence of deep venous obstruction

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Exclusion criteria - Heart/lung/kidney failure, pregnancy, diagnosis of peripheral vascular disease, previous VTE, ABPI<0.9, active infection, previous leg fracture or metal implant in leg
Group 2
Inclusion criteria - 18+ years old, 17<BMI<30, clinical diagnosis of superficial venous insufficiency (CEAP C2-6) confirmed with duplex US
Exclusion criteria - Heart/lung/kidney failure, pregnancy, ABPI<0.9, active infection, previous leg fracture or metal implant in leg
Group 3

Key exclusion criteria (0 listed)

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
geko deviceSmall transcutaneous electrical stimulator. Manufactured in UK by Firstkind UK Ltd, and licensed for use in humans	Device	Deep venous insufficiency, Deep venous obstruction, Healthy subjects, Superficial venous insufficiency

Primary outcome

Percentage Change of Haemodynamic Flow
Time frame: baseline, 20 minutes
Doppler ultrasound measurements of femoral venous blood flow. The volume flow rate in blood vessel can be calculated by multiplying the cross-sectional area of the blood vessel by the mean velocity of the blood within it.

2 secondary outcomes

Improvement in Venous Symptoms
Time frame: 6 weeks
Leg Volume
Time frame: 6 weeks

Results and safety

Results posted to the registry on 11 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Subjects	10	10
Superficial Venous Insufficiency	10	10
Deep Venous Insufficiency	10	10
Deep Venous Obstruction	10	10

Primary outcome: Percentage Change of Haemodynamic Flow

Time frame: baseline, 20 minutes. Median (Inter-Quartile Range). Unit: % change

Measure	Healthy Subjects n = 10	Superficial Venous Insufficiency n = 10	Deep Venous Insufficiency n = 10	Deep Venous Obstruction n = 10
Peak velocity	34.8 (-4 to 81)	62.8 (25 to 138)	9 (-10 to 84)	14.8 (-8 to 51)
TAMV time-averaged mean velocity	-14.2 (-30 to 55)	28.1 (-2 to 111)	28.2 (-30 to 66)	-5.1 (-28 to 35)
Volume flow	-22.5 (-40 to 40)	37.5 (-10 to 172)	17.4 (1 to 49)	5.9 (-11 to 21)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 10 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Subjects	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Superficial Venous Insufficiency	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Deep Venous Insufficiency	0 of 10 (0%)	0 of 10 (0%)	0 of 10
Deep Venous Obstruction	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34880620Williams KJ, Moore HM, Ellis M, Davies AH. Pilot Trial of Neuromuscular Stimulation in Human Subjects with Chronic Venous Disease. Vasc Health Risk Manag. 2021 Dec 1;17:771-778. doi: 10.2147/VHRM.S320883. eCollection 2021.
Individual participant dataSharing planned: No

Related trials for Chronic Venous Disease

Not yet recruiting
Phenotyping Rehabilitation for Improving Frailty, Functional Capacity
Varicose Veins
Active, not recruiting
Comparison of the Effects of Kinesio Taping and Interval Exercise in Patients Diagnosed With Venous Insufficiency: A Randomised Controlled Trial
Chronic Venous Insufficiency C2 and Below
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
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RecruitingPhase 4
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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.

Alun Davies principal investigator

Imperial College London

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing geko device in people with Chronic Venous Disease and Venous Insufficiency, run by Imperial College London at 1 site in United Kingdom.

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 10 inclusion and 0 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 25 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage Change of Haemodynamic Flow (time frame: baseline, 20 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02137499, which also lists 1 linked publication.

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 25 Oct 2019.