Venous InsufficiencyRVINCT02114307
REVITIVE for the Treatment of Patients With Venous Insufficiency
A study testing REVITIVE IX in people with Venous Insufficiency and Oedema, run by Imperial College London at 1 site in United Kingdom.
Trial summary
To investigate the efficacy of an electrical stimulation (using the REVITIVE IX device) in treating patients with venous insufficiency. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Insufficiency, Oedema, Varicose Veins
- What is being tested?
- REVITIVE IX
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2014to 1 Oct 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand the study and provide meaningful written informed consent for the study.
- Willing, able, and committed to participate in the procedures for the full length of the study.
- All ethnic groups, male or female above the age of 18 years.
- Diagnosis of chronic venous insufficiency (C2-C5 CEAP classified)
- Be of non-childbearing potential; or using adequate contraception and have a negative urine pregnancy test result within 24 hours if appropriate before using the device.
- Blood pressure currently under moderate control (<160/100mmHg)
- No current foot ulceration.
Who cannot join
- Has insufficient ability to understand the subject information sheet, consent form and verbal instruction.
- Has an unstable condition (eg psychiatric disorder, a recent history of substance abuse or otherwise thought to be unreliable or incapable of complying wight he requirements of the clinical investigational plan (CIP).
- Has any metal implants.
- Pregnant.
- Has a cardiac pacemaker, AICD or other implanted electrical device.
- Has an existing DVT.
Show all 13Show fewer
- Has an acute medical condition other than chronic venous insufficiency.
- Has recent lower limb injury or lower back pain.
- Has current foot ulceration or other skin ulcers.
- Has cardiovascular disease.
- Has foot deformities.
- Has any disorder that, in the opinion of the investigator, might interfere with the conduct of the study.
- Has an ABPI < 0.8.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Academic Department of Vascular Surgery, Charing Cross Hospital
London, W4 8RF
About this study
To investigate the efficacy of an electrical stimulation (using the REVITIVE IX device) in treating patients with venous insufficiency.
Read the detailed description
This is a pilot randomised control trial to assess the efficacy of a neuromuscular electrical stimulation device to improve venous blood flow and patients' symptoms in patients with chronic venous insufficiency. The Revitive IX device is a neuromuscular electrical stimulation device that gives wide pulse pattern electrical stimulation via foot pads. A cycle of treatment consists of a 30 minute programme of 15 varying waveforms that last a minute each.
Twenty patients with venous insufficiency will be screened according the eligibility criteria. Patients will be randomised to either treatment or control (sham device) group. Patients are advised to use the device 30 minutes a day, everyday, for 6 weeks. Compliance will be monitored with a data logger and diary card.
Primary outcome measure:
- improvement in venous haemodynamics.
Secondary outcome measures:
- improvement in lower limb oedema
- improvement in clinical symptoms
- reduction in lower limb pain and discomfort
- improvement in quality of life measures
- device satisfaction.
- Conditions
- Venous Insufficiency, Oedema, Varicose Veins
- Being tested
- REVITIVE IX
- Keywords
- electrical stimulation, venous insufficiency, post thrombotic syndrome, varicose veins
- Medical subject headings
- Venous Insufficiency, Edema, Varicose Veins, Postthrombotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REVITIVE IXDevice
neuromuscular electrical stimulation device
| Study group | Role | What they receive |
|---|---|---|
| REVITIVE IX: actual device | Active comparator | Trial participants will receive the true Revitive IX device Receives: Device: REVITIVE IX |
| REVITIVE IX: sham device | Sham comparator | Trial participants will receive a sham device Receives: Device: REVITIVE IX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV
Femoral vein haemodynamics is measured using ultrasound scan - Time Averaged Mean Velocity
Measured: 0 and 6 weeks
Secondary outcomes (2)
Changes in Limb Swelling, Volume
Lower limb oedema measured before and after using the device at 0 and 6 weeks using a perimeter.
Limb volume was measured using an optoelectronic limb volumeter. Patients using compression stockings were advised to remove stockings 2 h prior to their appointment. Measurements were taken with the patient seated and the affected leg in a horizontal position. Five readings were taken before and after device usage at Week 0 and Week 6
Measured: 0 and 6 weeks
Clinical Symptoms
Change in clinical symptoms as assessed by the Venous Clinical Severity Score (VCSS) from 0 to 6 weeks, lower score means improvement. Maximum score on VCSS is 30. Minimum score is 0.
Measured: 0 and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study start1 Mar 2014
- Primary completion1 Oct 2014
- Study completion1 Oct 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 Venous InsufficiencyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Actegy Ltd.
- Responsible party
- Sponsor
- Investigators
- Alun Davies, MA DM FRCS FHEA, Principal investigator, Imperial College London and Imperial College London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114307
- Sponsor's protocol ID
- 13HH0768
- Acronym
- RVI
- Status last verified
- Sep 2019
- First submitted
- 11 Apr 2014
- Last updated
- 10 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data available on request.
Publications
Ravikumar R, Williams KJ, Babber A, Lane TRA, Moore HM, Davies AH. Randomised Controlled Trial: Potential Benefit of a Footplate Neuromuscular Electrical Stimulation Device in Patients with Chronic Venous Disease. Eur J Vasc Endovasc Surg. 2017 Jan;53(1):114-121. doi: 10.1016/j.ejvs.2016.09.015. Epub 2016 Dec 2.
PubMed 27919609
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REVITIVE for the Treatment of Patients With Venous Insufficiency
- ClinicalTrials.gov ID
- NCT02114307
- Acronym / sponsor ID
- RVI / 13HH0768
- Conditions
- Venous Insufficiency, Oedema, Varicose Veins
- Keywords
- electrical stimulation, venous insufficiency, post thrombotic syndrome, varicose veins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Actegy Ltd.
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 1 Oct 2014 (actual)
- Study completion
- 1 Oct 2014 (actual)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Posted 10 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the efficacy of an electrical stimulation (using the REVITIVE IX device) in treating patients with venous insufficiency.
Detailed description
This is a pilot randomised control trial to assess the efficacy of a neuromuscular electrical stimulation device to improve venous blood flow and patients' symptoms in patients with chronic venous insufficiency. The Revitive IX device is a neuromuscular electrical stimulation device that gives wide pulse pattern electrical stimulation via foot pads. A cycle of treatment consists of a 30 minute programme of 15 varying waveforms that last a minute each.
Twenty patients with venous insufficiency will be screened according the eligibility criteria. Patients will be randomised to either treatment or control (sham device) group. Patients are advised to use the device 30 minutes a day, everyday, for 6 weeks. Compliance will be monitored with a data logger and diary card.
Primary outcome measure:
- improvement in venous haemodynamics.
Secondary outcome measures:
- improvement in lower limb oedema
- improvement in clinical symptoms
- reduction in lower limb pain and discomfort
- improvement in quality of life measures
- device satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REVITIVE IX: actual device | Active comparator | Device: REVITIVE IXTrial participants will receive the true Revitive IX device |
| REVITIVE IX: sham device | Sham comparator | Device: REVITIVE IXTrial participants will receive a sham device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability to understand the study and provide meaningful written informed consent for the study.
- Willing, able, and committed to participate in the procedures for the full length of the study.
- All ethnic groups, male or female above the age of 18 years.
- Diagnosis of chronic venous insufficiency (C2-C5 CEAP classified)
- Be of non-childbearing potential; or using adequate contraception and have a negative urine pregnancy test result within 24 hours if appropriate before using the device.
Key exclusion criteria (13 listed)
- Has insufficient ability to understand the subject information sheet, consent form and verbal instruction.
- Has an unstable condition (eg psychiatric disorder, a recent history of substance abuse or otherwise thought to be unreliable or incapable of complying wight he requirements of the clinical investigational plan (CIP).
- Has any metal implants.
- Pregnant.
- Has a cardiac pacemaker, AICD or other implanted electrical device.
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 |
|---|---|---|
| REVITIVE IXneuromuscular electrical stimulation device | Device | REVITIVE IX: actual device, REVITIVE IX: sham device |
Primary outcome
Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV
Time frame: 0 and 6 weeks
Femoral vein haemodynamics is measured using ultrasound scan - Time Averaged Mean Velocity
2 secondary outcomes
Changes in Limb Swelling, Volume
Time frame: 0 and 6 weeks
Clinical Symptoms
Time frame: 0 and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27919609Ravikumar R, Williams KJ, Babber A, Lane TRA, Moore HM, Davies AH. Randomised Controlled Trial: Potential Benefit of a Footplate Neuromuscular Electrical Stimulation Device in Patients with Chronic Venous Disease. Eur J Vasc Endovasc Surg. 2017 Jan;53(1):114-121. doi: 10.1016/j.ejvs.2016.09.015. Epub 2016 Dec 2.
- Individual participant dataSharing planned: Yes. Data available on request.
Related trials for Venous Insufficiency
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
Not yet recruiting
Phenotyping Rehabilitation for Improving Frailty, Functional Capacity
Varicose Veins
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)
Staphylococcus Aureus
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
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
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, MA DM FRCS FHEA principal investigator
Imperial College London and Imperial College London NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REVITIVE IX in people with Venous Insufficiency and Oedema, 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 7 inclusion and 13 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 10 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. Some participants in this study may receive a placebo. 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 10 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?
Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV (time frame: 0 and 6 weeks). 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 NCT02114307, 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 10 Oct 2019.