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| ID | Type | Description | Link |
|---|---|---|---|
| CR02072 | Other Identifier | Imperial College London |
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The investigators will be evaluating the immediate and longer term effect of treatment with a medical device on the symptoms of chronic venous disease.
STUDY AIMS
METHODS Controlled interventional trial. Group 1 (10 subjects) will be healthy subjects with no clinical venous disease. Subjects with venous incompetence to be recruited into one of three groups. Group 2 (10 subjects) will have superficial venous incompetence; Group 3 (10 subjects) will have deep venous incompetence; Group 4 (10 subjects) will have deep vein occlusion. These will be clinical diagnoses confirmed with duplex ultrasound.
The device used in this study will be the geko™ T-1 device (Firstkind Ltd, UK). A geko™ device will be fitted to each leg. The device stimulation level is set to the minimum level that can achieve the desired response (outward and upward twitching of the foot when raised from the ground).
ENDPOINTS Primary end-point
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy subjects | Active Comparator | Healthy subjects, free from vascular disease |
|
| Superficial venous insufficiency | Experimental | Clinically symptomatic and ultrasound evidence of superficial venous insufficiency |
|
| Deep venous insufficiency | Experimental | Clinically symptomatic and ultrasound evidence of deep venous insufficiency |
|
| Deep venous obstruction | Experimental | Clinically symptomatic and ultrasound evidence of deep venous obstruction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| geko device | Device | Small transcutaneous electrical stimulator. Manufactured in UK by Firstkind UK Ltd, and licensed for use in humans |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change of Haemodynamic Flow | Doppler ultrasound measurements of femoral venous blood flow. The volume flow rate in blood vessel can be calculated by multiplying the cross-sectional area of the blood vessel by the mean velocity of the blood within it. | baseline, 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Venous Symptoms | Clinical symptoms will be measured using questionnaires (AVVQ, VCSS) | 6 weeks |
| Leg Volume | Measured using ankle and calf circumference, and multiplying using "inverted cone" method |
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Group 1
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| Name | Affiliation | Role |
|---|---|---|
| Alun Davies | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charing Cross Hospital | Hammersmith | London | W6 8RF | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34880620 | Derived | Williams KJ, Moore HM, Ellis M, Davies AH. Pilot Trial of Neuromuscular Stimulation in Human Subjects with Chronic Venous Disease. Vasc Health Risk Manag. 2021 Dec 1;17:771-778. doi: 10.2147/VHRM.S320883. eCollection 2021. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Subjects | Healthy participants treated with Small transcutaneous electrical stimulator |
| FG001 | Superficial Venous Insufficiency | Participants with Superficial venous insufficiency treated with Small transcutaneous electrical stimulator |
| FG002 | Deep Venous Insufficiency | Participant with Deep venous insufficiency treated with Small transcutaneous electrical stimulator |
| FG003 | Deep Venous Obstruction | Participant with Deep venous obstruction treated with Small transcutaneous electrical stimulator |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Subjects | Healthy participants treated with Small transcutaneous electrical stimulator |
| BG001 | Superficial Venous Insufficiency | Participants with Superficial venous insufficiency treated with Small transcutaneous electrical stimulator |
| 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 | Percentage Change of Haemodynamic Flow | Doppler ultrasound measurements of femoral venous blood flow. The volume flow rate in blood vessel can be calculated by multiplying the cross-sectional area of the blood vessel by the mean velocity of the blood within it. | Posted | Median | Inter-Quartile Range | % change | baseline, 20 minutes |
|
10 weeks
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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 | Healthy Subjects | Healthy participants treated with Small transcutaneous electrical stimulator |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Miss Kate Williams | Imperial College London | k.williams@imperial.ac.uk |
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| ID | Term |
|---|---|
| D014689 | Venous Insufficiency |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| 6 weeks |
| BG002 | Deep Venous Insufficiency | Participants with Deep venous insufficiency treated with Small transcutaneous electrical stimulator |
| BG003 | Deep Venous Obstruction | Participants with Deep venous obstruction treated with Small transcutaneous electrical stimulator |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Deep Venous Insufficiency |
Participants with Deep venous insufficiency treated with Small transcutaneous electrical stimulator |
| OG003 | Deep Venous Obstruction | Participants with Deep venous obstruction treated with Small transcutaneous electrical stimulator |
|
|
| Secondary | Improvement in Venous Symptoms | Clinical symptoms will be measured using questionnaires (AVVQ, VCSS) | Data not collected | Posted | 6 weeks |
|
|
| Secondary | Leg Volume | Measured using ankle and calf circumference, and multiplying using "inverted cone" method | Data not collected | Posted | 6 weeks |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Superficial Venous Insufficiency | Participants with Superficial venous insufficiency treated with Small transcutaneous electrical stimulator | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Deep Venous Insufficiency | Participants with Deep venous insufficiency treated with Small transcutaneous electrical stimulator | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | Deep Venous Obstruction | Participants with Deep venous obstruction treated with Small transcutaneous electrical stimulator | 0 | 10 | 0 | 10 | 0 | 10 |
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| Male |
|