Varicose VeinsDESIVINCT03850496
DESIVI: Dosing of Electrical Stimulation in Venous Insufficiency
A study testing Revitive IX Neuromuscular Stimulation Device in people with Varicose Veins and Venous Stasis, run by Imperial College London.
Trial summary
This study is designed to describe the difference in varicose vein outcomes found from using a neuromuscular electrical stimulation device for different amounts of time - Group A (control - no device), Group B (device for 30 mins per day) and Group C (device for 60 mins per day). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins, Venous Stasis, Venous Insufficiency
- What is being tested?
- Revitive IX Neuromuscular Stimulation Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2015to 31 Oct 2016
- 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
- Patients with chronic venous insufficiency who have the following are eligible for the study:
- Able 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 (C3-C5 CEAP Classification)
- Blood pressure currently under moderate control (< 160/100mmHg)
- No current foot ulceration
Who cannot join
- Patients meeting any of the following criteria are to be excluded:
- Has an unstable condition (eg, psychiatric disorder, a recent history of substance abuse) that would affect compliance with protocol
- Pregnant
- Has a cardiac pacemaker, AICD or other implanted electrical device
- Has an Existing DVT.
- Has recent lower limb injury or lower back pain
Show all 9Show fewer
- Has current foot ulceration or other skin ulcers
- Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study.
- Has an ABPI < 0.8
About this study
Official title: Dosing of Electrical Stimulation in Venous Insufficiency
This study is designed to describe the difference in varicose vein outcomes found from using a neuromuscular electrical stimulation device for different amounts of time - Group A (control - no device), Group B (device for 30 mins per day) and Group C (device for 60 mins per day). The groups are assessed after 6 weeks of intervention.
- Conditions
- Varicose Veins, Venous Stasis, Venous Insufficiency
- Being tested
- Revitive IX Neuromuscular Stimulation Device
- Keywords
- Venous
- Medical subject headings
- Varicose Veins, Varicose Ulcer, Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revitive IX Neuromuscular Stimulation DeviceDevice
Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence.
| Study group | Role | What they receive |
|---|---|---|
| Group A | No intervention | No device utilised for 6 weeks. |
| Group B | Experimental | Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 30 mins / day for 6 weeks. Receives: Device: Revitive IX Neuromuscular Stimulation Device |
| Group C | Experimental | Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 60 mins / day for 6 weeks. Receives: Device: Revitive IX Neuromuscular Stimulation Device |
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
Assessment of change in venous flow utilising Time Averaged Mean Velocity (TAMV) (measured in cm/s), assessed as percentage change from baseline.
Measured: 0 and 6 weeks
Secondary outcomes (10)
Venous Flow Parameters - PV
Assessment of change in venous flow utilising Peak Velocity (PV) (measured in cm/s), assessed as percentage change from baseline.
Measured: 0 and 6 weeks
Venous Flow Parameters - VF
Assessment of change in venous flow utilising Volume Flow (VF) (measured in cc/min), assessed as percentage change from baseline.
Measured: 0 and 6 weeks
Microcirculatory Blood Flow
Microcirculatory blood flow measure utilising flux arbitrary units.
Measured: 0 and 6 weeks.
Limb Volume
Change in limb volume assessed in ml.
Measured: 0 and 6 weeks
Venous Clinical Severity
Clinical severity of venous disease as measured by the venous clinical severity score (VCSS). Scale measure from 0-30, with higher values indicating worse status. It is made up of 10 variables scored from 0-3
Measured: 0 and 6 weeks.
Patient Compliance
Compliance with device usage assessed with a patient completed diary.
Measured: 6 weeks.
Generic Quality of Life - EQ-5D-5L
Quality of life as assessed by the EuroQol EQ-5D generic quality of life questionnaire. This measures from 1.00 (perfect life) to 0.00 (dead) and to negative values (worse than dead).
Measured: 0 and 6 weeks
Generic Quality of Life - SF-12
Quality of life as assessed by the Short Form 12 (SF-12) generic quality of life tool. Assessed at baseline and 6 weeks.
Measured: 0 and 6 weeks
Generic Quality of Life - EQ-VAS
Quality of life as assessed by the EuroQol Visual Analogue Scale (0-100) for generic Quality of life - EQ-VAS. Higher values better.
Measured: 0 and 6 weeks
Disease Specific Quality of Life
quality of life as assessed on the Aberdeen varicose vein questionnaire scale (0-100). This is a patient reported quality of life measure, which assesses symptoms of varicose veins. Higher values are worse.
Measured: 0 weeks 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 posted21 Feb 2019
- Study start1 Nov 2015
- Primary completion31 Aug 2016
- Study completion31 Oct 2016
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.
- Other trials for Varicose VeinsStudies 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
- Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Actegy Ltd.
- Responsible party
- Sponsor
- Investigators
- Raveena Ravikumar, MRCS, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850496
- Sponsor's protocol ID
- 15HH2472
- Other IDs
- 171441, 15/LO/0620
- Acronym
- DESIVI
- Status last verified
- Jul 2020
- First submitted
- 19 Feb 2019
- Last updated
- 31 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available on request.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosing of Electrical Stimulation in Venous Insufficiency
- ClinicalTrials.gov ID
- NCT03850496
- Acronym / sponsor ID
- DESIVI / 15HH2472
- Conditions
- Varicose Veins, Venous Stasis, Venous Insufficiency
- Keywords
- Venous
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Actegy Ltd.
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Posted 4 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to describe the difference in varicose vein outcomes found from using a neuromuscular electrical stimulation device for different amounts of time - Group A (control - no device), Group B (device for 30 mins per day) and Group C (device for 60 mins per day). The groups are assessed after 6 weeks of intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | –No device utilised for 6 weeks. |
| Group B | Experimental | Device: Revitive IX Neuromuscular Stimulation DeviceRevitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 30 mins / day for 6 weeks. |
| Group C | Experimental | Device: Revitive IX Neuromuscular Stimulation DeviceRevitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 60 mins / day for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with chronic venous insufficiency who have the following are eligible for the study:
- Able 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 (C3-C5 CEAP Classification)
Key exclusion criteria (9 listed)
- Has an unstable condition (eg, psychiatric disorder, a recent history of substance abuse) that would affect compliance with protocol
- Pregnant
- Has a cardiac pacemaker, AICD or other implanted electrical device
- Has an Existing DVT.
- Has recent lower limb injury or lower back pain
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 IX Neuromuscular Stimulation DeviceNeuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence. | Device | Group B, Group C |
Primary outcome
Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV
Time frame: 0 and 6 weeks
Assessment of change in venous flow utilising Time Averaged Mean Velocity (TAMV) (measured in cm/s), assessed as percentage change from baseline.
10 secondary outcomes
Venous Flow Parameters - PV
Time frame: 0 and 6 weeks
Venous Flow Parameters - VF
Time frame: 0 and 6 weeks
Microcirculatory Blood Flow
Time frame: 0 and 6 weeks.
Limb Volume
Time frame: 0 and 6 weeks
Venous Clinical Severity
Time frame: 0 and 6 weeks.
Patient Compliance
Time frame: 6 weeks.
Generic Quality of Life - EQ-5D-5L
Time frame: 0 and 6 weeks
Generic Quality of Life - SF-12
Time frame: 0 and 6 weeks
Generic Quality of Life - EQ-VAS
Time frame: 0 and 6 weeks
Disease Specific Quality of Life
Time frame: 0 weeks and 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Available on request.
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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.
Raveena Ravikumar, MRCS principal investigator
Imperial College London
Questions about this trial
What is this clinical trial studying?
A study testing Revitive IX Neuromuscular Stimulation Device in people with Varicose Veins and Venous Stasis, run by Imperial College London.
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 9 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 31 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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 4 Sep 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?
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 31 Jul 2020.