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| ID | Type | Description | Link |
|---|---|---|---|
| 171441 | Other Identifier | IRAS Project ID | |
| 15/LO/0620 | Other Identifier | National Research Ethics Number |
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| Name | Class |
|---|---|
| Actegy Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Group C | Experimental | Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 60 mins / day for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Revitive IX Neuromuscular Stimulation Device | Device | Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 and 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Venous Flow Parameters - PV | Assessment of change in venous flow utilising Peak Velocity (PV) (measured in cm/s), assessed as percentage change from baseline. | 0 and 6 weeks |
| Venous Flow Parameters - VF |
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Inclusion Criteria:
Patients with chronic venous insufficiency who have the following are eligible for the study:
Exclusion Criteria:
Patients meeting any of the following criteria are to be excluded:
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| Name | Affiliation | Role |
|---|---|---|
| Raveena Ravikumar, MRCS | Imperial College London | Principal Investigator |
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Available on request.
Post publication.
On direct communication with researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | No device utilised for 6 weeks. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | No device utilised for 6 weeks. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | percentage change from device off | 0 and 6 weeks |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group A | No device utilised for 6 weeks. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Tristan Lane, Clinical Lecturer | Imperial College London | 02033117317 | tristan.lane@imperial.ac.uk |
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| ID | Term |
|---|---|
| D014648 | Varicose Veins |
| D014647 | Varicose Ulcer |
| D014689 | Venous Insufficiency |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D012883 | Skin Ulcer |
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Assessment of change in venous flow utilising Volume Flow (VF) (measured in cc/min), assessed as percentage change from baseline.
| 0 and 6 weeks |
| Microcirculatory Blood Flow | Microcirculatory blood flow measure utilising flux arbitrary units. | 0 and 6 weeks. |
| Limb Volume | Change in limb volume assessed in ml. | 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 | 0 and 6 weeks. |
| Patient Compliance | Compliance with device usage assessed with a patient completed diary. | 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). | 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. | 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. | 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. | 0 weeks and 6 weeks |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | 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. |
|
|
| 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. | Posted | Median | Inter-Quartile Range | percentage change from device off | 0 and 6 weeks |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | percentage change from device off | 0 and 6 weeks |
|
|
|
| Secondary | Microcirculatory Blood Flow | Microcirculatory blood flow measure utilising flux arbitrary units. | Not Posted | 0 and 6 weeks. | Participants |
| Secondary | Limb Volume | Change in limb volume assessed in ml. | Not Posted | 0 and 6 weeks | Participants |
| 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 | Posted | Median | Inter-Quartile Range | Units on a scale | 0 and 6 weeks. |
|
|
|
| Secondary | Patient Compliance | Compliance with device usage assessed with a patient completed diary. | Not Posted | 6 weeks. | Participants |
| 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). | Not Posted | 0 and 6 weeks | Participants |
| 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. | Not Posted | 0 and 6 weeks | Participants |
| 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. | Not Posted | 0 and 6 weeks | Participants |
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | 0 weeks and 6 weeks |
|
|
|
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
| EG001 | 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. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | 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. | 0 | 25 | 0 | 25 | 0 | 25 |
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| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Male |
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