VeINS: Venous Insufficiency and Neuromuscular Stimulation

• Sponsor: Imperial College London (Other)
• Overall Status: Completed
• CT.gov ID: NCT02137499
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 4
• Actual Duration (Months): 11
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

The investigators will be evaluating the immediate and longer term effect of treatment with a medical device on the symptoms of chronic venous disease.

Condition or Disease	Intervention/Treatment	Phase
Chronic Venous Disease; Venous Insufficiency; Deep Venous Obstruction	Device: geko device	N/A

Detailed Description

STUDY AIMS

1. To obtain ultrasound blood flow and velocity measurements in the leg to compare the hemodynamic profiles obtained using a neuromuscular stimulation device with those obtained at rest.

2. To ascertain if a 6 week protocol of electrical neurostimulation of the muscle pumps in the leg and foot can reduce clinical symptoms and improve quality of life.

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

• Increase in venous flow Secondary end points

• Improvement in clinical symptoms at 6 weeks, as judged by questionnaire

• Reduction in absolute leg diameter and volume at 6 weeks

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Venous Insufficiency and Neuromuscular Stimulation
• Actual Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Jul 1, 2014
• Actual Study Completion Date: Jul 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Healthy subjects Healthy subjects, free from vascular disease	Device: geko device; Small transcutaneous electrical stimulator. Manufactured in UK by Firstkind UK Ltd, and licensed for use in humans
Experimental: Superficial venous insufficiency Clinically symptomatic and ultrasound evidence of superficial venous insufficiency	Device: geko device; Small transcutaneous electrical stimulator. Manufactured in UK by Firstkind UK Ltd, and licensed for use in humans
Experimental: Deep venous insufficiency Clinically symptomatic and ultrasound evidence of deep venous insufficiency	Device: geko device; Small transcutaneous electrical stimulator. Manufactured in UK by Firstkind UK Ltd, and licensed for use in humans
Experimental: Deep venous obstruction Clinically symptomatic and ultrasound evidence of deep venous obstruction	Device: geko device; Small transcutaneous electrical stimulator. Manufactured in UK by Firstkind UK Ltd, and licensed for use in humans

Outcome Measures

Primary Outcome Measures

1. Percentage Change of Haemodynamic Flow [baseline, 20 minutes]

   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.

Secondary Outcome Measures

1. Improvement in Venous Symptoms [6 weeks]

   Clinical symptoms will be measured using questionnaires (AVVQ, VCSS)

2. Leg Volume [6 weeks]

   Measured using ankle and calf circumference, and multiplying using "inverted cone" method

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Group 1

• Inclusion criteria - 18+ years old, 17<BMI<30

• Exclusion criteria - Heart/lung/kidney failure, pregnancy, diagnosis of peripheral vascular disease, previous VTE, ABPI<0.9, active infection, previous leg fracture or metal implant in leg

Group 2

• Inclusion criteria - 18+ years old, 17<BMI<30, clinical diagnosis of superficial venous insufficiency (CEAP C2-6) confirmed with duplex US

• Exclusion criteria - Heart/lung/kidney failure, pregnancy, ABPI<0.9, active infection, previous leg fracture or metal implant in leg

Group 3

• Inclusion criteria - 18+ years old, 17<BMI<30, clinical diagnosis of deep venous insufficiency (CEAP C2-6) confirmed with duplex US

• Exclusion criteria - Heart/lung/kidney failure, pregnancy, ABPI<0.9, active infection, previous leg fracture or metal implant in leg

Group 4

• Inclusion criteria - 18+ years old, 17<BMI<30, clinical diagnosis of deep venous obstruction confirmed with duplex US

• Exclusion criteria - Heart/lung/kidney failure, pregnancy, ABPI<0.9, active infection, previous leg fracture or metal implant in leg

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Charing Cross Hospital	Hammersmith	London	United Kingdom	W6 8RF

Sponsors and Collaborators

• Imperial College London

Investigators

• Principal Investigator: Alun Davies, Imperial College London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT02137499
• Other Study ID Numbers: 13/WM/0027; CR02072
• First Posted: May 13, 2014
• Last Update Posted: Oct 25, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Imperial College London: Deep venous obstruction; Venous insufficiency
• Additional relevant MeSH terms: Venous Insufficiency

Study Results

Participant Flow

Arm/Group Title	Healthy Subjects	Superficial Venous Insufficiency	Deep Venous Insufficiency	Deep Venous Obstruction
Arm/Group Description	Healthy participants treated with Small transcutaneous electrical stimulator	Participants with Superficial venous insufficiency treated with Small transcutaneous electrical stimulator	Participant with Deep venous insufficiency treated with Small transcutaneous electrical stimulator	Participant with Deep venous obstruction treated with Small transcutaneous electrical stimulator
Period Title: Overall Study
STARTED	10	10	10	10
COMPLETED	10	10	10	10
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Healthy Subjects	Superficial Venous Insufficiency	Deep Venous Insufficiency	Deep Venous Obstruction	Total
Arm/Group Description	Healthy participants treated with Small transcutaneous electrical stimulator	Participants with Superficial venous insufficiency treated with Small transcutaneous electrical stimulator	Participants with Deep venous insufficiency treated with Small transcutaneous electrical stimulator	Participants with Deep venous obstruction treated with Small transcutaneous electrical stimulator	Total of all reporting groups
Overall Participants	10	10	10	10	40
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.7 (10)	55 (15)	58.6 (18)	53.2 (16)	56 (12)
Sex: Female, Male (Count of Participants)
Female	5 50%	6 60%	2 20%	3 30%	16 40%
Male	5 50%	4 40%	8 80%	7 70%	24 60%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage Change of Haemodynamic Flow
Description	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.
Time Frame	baseline, 20 minutes

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Healthy Subjects	Superficial Venous Insufficiency	Deep Venous Insufficiency	Deep Venous Obstruction
Arm/Group Description	Healthy participants treated with Small transcutaneous electrical stimulator	Participants with Superficial venous insufficiency treated with Small transcutaneous electrical stimulator	Participants with Deep venous insufficiency treated with Small transcutaneous electrical stimulator	Participants with Deep venous obstruction treated with Small transcutaneous electrical stimulator
Measure Participants	10	10	10	10
Peak velocity	34.8	62.8	9	14.8
TAMV time-averaged mean velocity	-14.2	28.1	28.2	-5.1
Volume flow	-22.5	37.5	17.4	5.9

2. Secondary Outcome

Title	Improvement in Venous Symptoms
Description	Clinical symptoms will be measured using questionnaires (AVVQ, VCSS)
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Data not collected

Arm/Group Title	Healthy Subjects	Superficial Venous Insufficiency	Deep Venous Insufficiency	Deep Venous Obstruction
Arm/Group Description	Healthy participants treated with Small transcutaneous electrical stimulator	Participants with Superficial venous insufficiency treated with Small transcutaneous electrical stimulator	Participants with Deep venous insufficiency treated with Small transcutaneous electrical stimulator	Participants with Deep venous obstruction treated with Small transcutaneous electrical stimulator
Measure Participants	0	0	0	0

3. Secondary Outcome

Title	Leg Volume
Description	Measured using ankle and calf circumference, and multiplying using "inverted cone" method
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Data not collected

Arm/Group Title	Healthy Subjects	Superficial Venous Insufficiency	Deep Venous Insufficiency	Deep Venous Obstruction
Arm/Group Description	Healthy participants treated with Small transcutaneous electrical stimulator	Participants with Superficial venous insufficiency treated with Small transcutaneous electrical stimulator	Participants with Deep venous insufficiency treated with Small transcutaneous electrical stimulator	Participants with Deep venous obstruction treated with Small transcutaneous electrical stimulator
Measure Participants	0	0	0	0

Adverse Events

Time Frame	10 weeks
Arm/Group Title	Healthy Subjects		Superficial Venous Insufficiency		Deep Venous Insufficiency		Deep Venous Obstruction
Arm/Group Description	Healthy participants treated with Small transcutaneous electrical stimulator		Participants with Superficial venous insufficiency treated with Small transcutaneous electrical stimulator		Participants with Deep venous insufficiency treated with Small transcutaneous electrical stimulator		Participants with Deep venous obstruction treated with Small transcutaneous electrical stimulator
All Cause Mortality
	Healthy Subjects		Superficial Venous Insufficiency		Deep Venous Insufficiency		Deep Venous Obstruction
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)
Serious Adverse Events
	Healthy Subjects		Superficial Venous Insufficiency		Deep Venous Insufficiency		Deep Venous Obstruction
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Healthy Subjects		Superficial Venous Insufficiency		Deep Venous Insufficiency		Deep Venous Obstruction
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)		0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.