Oedema, Varicose Veins, Venous Insufficiency
Conditions
Keywords
electrical stimulation, venous insufficiency, post thrombotic syndrome, varicose veins
Brief summary
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: a) improvement in venous haemodynamics. Secondary outcome measures: 1. improvement in lower limb oedema 2. improvement in clinical symptoms 3. reduction in lower limb pain and discomfort 4. improvement in quality of life measures 5. device satisfaction.
Interventions
DEVICEREVITIVE IX
neuromuscular electrical stimulation device
Sponsors
Actegy Ltd.
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV | 0 and 6 weeks | Femoral vein haemodynamics is measured using ultrasound scan - Time Averaged Mean Velocity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Limb Swelling, Volume | 0 and 6 weeks | 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 |
| Clinical Symptoms | 0 and 6 weeks | 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. |
Countries
United Kingdom
Participant flow
Recruitment details
Recruitment from vascular outpatients clinic between 20/02/2014 - 18/09/2014.
Pre-assignment details
Patient stayed in the full length of the study. Chronic venous insufficiency (C2-C5 CEAP). Blood pressure \<160/100mmHg. No current foot ulceration
Participants by arm
| Arm | Count |
|---|---|
| Test Device Patients received the REVITIVE IX device for 6 weeks of home usage. | 11 |
| Sham Device Sham REVITIVE IX for 6 weeks of home usage. | 11 |
| Total | 22 |
Baseline characteristics
| Characteristic | Test Device | Sham Device | Total |
|---|---|---|---|
| Age, Continuous | 70.0 years STANDARD_DEVIATION 12.4 | 54.6 years STANDARD_DEVIATION 13.7 | 62.3 years STANDARD_DEVIATION 13 |
| Region of Enrollment United Kingdom | 11 participants | 11 participants | 22 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
Primary
Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV
Femoral vein haemodynamics is measured using ultrasound scan - Time Averaged Mean Velocity
Time frame: 0 and 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REVITIVE IX: Actual Device | Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV | 102.4 percentage change | Standard Deviation 50 |
| REVITIVE IX: Sham Device | Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV | -9.1 percentage change | Standard Deviation 50 |
p-value: 0.001Wilcoxon (Mann-Whitney)
Secondary
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
Time frame: 0 and 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| REVITIVE IX: Actual Device | Changes in Limb Swelling, Volume | week 0 prestimulation | 5377 ml | Standard Deviation 1122 |
| REVITIVE IX: Actual Device | Changes in Limb Swelling, Volume | week 0 poststimulation | 5422 ml | Standard Deviation 1127 |
| REVITIVE IX: Actual Device | Changes in Limb Swelling, Volume | week 6 prestimulation | 5500 ml | Standard Deviation 1173 |
| REVITIVE IX: Actual Device | Changes in Limb Swelling, Volume | week 6 post stimulation | 5553 ml | Standard Deviation 1168 |
| REVITIVE IX: Sham Device | Changes in Limb Swelling, Volume | week 6 post stimulation | 5203 ml | Standard Deviation 1272 |
| REVITIVE IX: Sham Device | Changes in Limb Swelling, Volume | week 0 prestimulation | 5107 ml | Standard Deviation 1252 |
| REVITIVE IX: Sham Device | Changes in Limb Swelling, Volume | week 6 prestimulation | 5143 ml | Standard Deviation 1269 |
| REVITIVE IX: Sham Device | Changes in Limb Swelling, Volume | week 0 poststimulation | 5208 ml | Standard Deviation 1252 |
Comparison: Sham Group - 6 week Time Point - Pre-stimulation versus Post-Stimulationp-value: 0.0023t-test, 2 sided
Comparison: Test Group - 6 week Time Point - Pre-stimulation versus Post-Stimulationp-value: 0.0815t-test, 2 sided
Secondary
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.
Time frame: 0 and 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| REVITIVE IX: Actual Device | Clinical Symptoms | -11.8 Percentage change in VCSS score | Standard Deviation 31.2 |
| REVITIVE IX: Sham Device | Clinical Symptoms | 6.4 Percentage change in VCSS score | Standard Deviation 20.7 |
p-value: 0.127t-test, 1 sided