Varicose Veins, Venous Insufficiency, Venous Stasis
Conditions
Keywords
Venous
Brief 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). The groups are assessed after 6 weeks of intervention.
Interventions
DEVICERevitive IX Neuromuscular Stimulation Device
Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence.
Sponsors
Actegy Ltd.
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Venous Flow Parameters - VF | 0 and 6 weeks | Assessment of change in venous flow utilising Volume Flow (VF) (measured in cc/min), assessed as percentage change from baseline. |
| Microcirculatory Blood Flow | 0 and 6 weeks. | Microcirculatory blood flow measure utilising flux arbitrary units. |
| Limb Volume | 0 and 6 weeks | Change in limb volume assessed in ml. |
| Venous Clinical Severity | 0 and 6 weeks. | 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 |
| Venous Flow Parameters - PV | 0 and 6 weeks | Assessment of change in venous flow utilising Peak Velocity (PV) (measured in cm/s), assessed as percentage change from baseline. |
| Generic Quality of Life - EQ-5D-5L | 0 and 6 weeks | 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). |
| Generic Quality of Life - SF-12 | 0 and 6 weeks | Quality of life as assessed by the Short Form 12 (SF-12) generic quality of life tool. Assessed at baseline and 6 weeks. |
| Generic Quality of Life - EQ-VAS | 0 and 6 weeks | Quality of life as assessed by the EuroQol Visual Analogue Scale (0-100) for generic Quality of life - EQ-VAS. Higher values better. |
| Disease Specific Quality of Life | 0 weeks and 6 weeks | 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. |
| Patient Compliance | 6 weeks. | Compliance with device usage assessed with a patient completed diary. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A No device utilised for 6 weeks. | 26 |
| Group B Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 30 mins / day for 6 weeks.
Revitive IX Neuromuscular Stimulation Device: Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence. | 25 |
| Group C Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 60 mins / day for 6 weeks.
Revitive IX Neuromuscular Stimulation Device: Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence. | 25 |
| Total | 76 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 4 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Group B | Group C | Total | Group A |
|---|---|---|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 5 | 63 years STANDARD_DEVIATION 5 | 60 years STANDARD_DEVIATION 5 | 59 years STANDARD_DEVIATION 5 |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 25 participants | 25 participants | 76 participants | 26 participants |
| Sex: Female, Male Female | 9 Participants | 12 Participants | 29 Participants | 8 Participants |
| Sex: Female, Male Male | 16 Participants | 13 Participants | 47 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 26 | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 26 | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 26 | 0 / 25 | 0 / 25 |
Outcome results
Primary
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.
Time frame: 0 and 6 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group A | Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV | 0 weeks | 3.36 percentage change from device off |
| Group A | Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV | 6 weeks | 0.46 percentage change from device off |
| Group B | Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV | 0 weeks | 26.58 percentage change from device off |
| Group B | Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV | 6 weeks | 27.83 percentage change from device off |
| Group C | Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV | 0 weeks | 39.49 percentage change from device off |
| Group C | Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV | 6 weeks | 36.38 percentage change from device off |
Secondary
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.
Time frame: 0 weeks and 6 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group A | Disease Specific Quality of Life | 0 weeks | 18.62 units on a scale |
| Group A | Disease Specific Quality of Life | 6 weeks | 19.72 units on a scale |
| Group B | Disease Specific Quality of Life | 0 weeks | 21.07 units on a scale |
| Group B | Disease Specific Quality of Life | 6 weeks | 18.86 units on a scale |
| Group C | Disease Specific Quality of Life | 0 weeks | 21.30 units on a scale |
| Group C | Disease Specific Quality of Life | 6 weeks | 15.01 units on a scale |
Secondary
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).
Time frame: 0 and 6 weeks
Secondary
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.
Time frame: 0 and 6 weeks
Secondary
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.
Time frame: 0 and 6 weeks
Secondary
Limb Volume
Change in limb volume assessed in ml.
Time frame: 0 and 6 weeks
Secondary
Microcirculatory Blood Flow
Microcirculatory blood flow measure utilising flux arbitrary units.
Time frame: 0 and 6 weeks.
Secondary
Patient Compliance
Compliance with device usage assessed with a patient completed diary.
Time frame: 6 weeks.
Secondary
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
Time frame: 0 and 6 weeks.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group A | Venous Clinical Severity | 0 weeks | 6 Units on a scale |
| Group A | Venous Clinical Severity | 6 weeks | 7 Units on a scale |
| Group B | Venous Clinical Severity | 6 weeks | 5 Units on a scale |
| Group B | Venous Clinical Severity | 0 weeks | 6 Units on a scale |
| Group C | Venous Clinical Severity | 0 weeks | 7 Units on a scale |
| Group C | Venous Clinical Severity | 6 weeks | 3 Units on a scale |
Secondary
Venous Flow Parameters - PV
Assessment of change in venous flow utilising Peak Velocity (PV) (measured in cm/s), assessed as percentage change from baseline.
Time frame: 0 and 6 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group A | Venous Flow Parameters - PV | 0 Week | -4.760 percentage change from device off |
| Group A | Venous Flow Parameters - PV | 6 Weeks | 3.360 percentage change from device off |
| Group B | Venous Flow Parameters - PV | 0 Week | 202.7 percentage change from device off |
| Group B | Venous Flow Parameters - PV | 6 Weeks | 145.8 percentage change from device off |
| Group C | Venous Flow Parameters - PV | 0 Week | 151.9 percentage change from device off |
| Group C | Venous Flow Parameters - PV | 6 Weeks | 246.6 percentage change from device off |
Secondary
Venous Flow Parameters - VF
Assessment of change in venous flow utilising Volume Flow (VF) (measured in cc/min), assessed as percentage change from baseline.
Time frame: 0 and 6 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group A | Venous Flow Parameters - VF | 0 weeks | 5.525 percentage change from device off |
| Group A | Venous Flow Parameters - VF | 6 weeks | -6.145 percentage change from device off |
| Group B | Venous Flow Parameters - VF | 6 weeks | 29.11 percentage change from device off |
| Group B | Venous Flow Parameters - VF | 0 weeks | 28.81 percentage change from device off |
| Group C | Venous Flow Parameters - VF | 0 weeks | 52.82 percentage change from device off |
| Group C | Venous Flow Parameters - VF | 6 weeks | 52.82 percentage change from device off |