DESIVI: Dosing of Electrical Stimulation in Venous Insufficiency

• Sponsor: Imperial College London (Other)
• Overall Status: Completed
• CT.gov ID: NCT03850496
• Collaborator: Actegy Ltd. (Industry)
• Enrollment: 76
• Arms: 3
• Actual Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Varicose Veins; Venous Stasis; Venous Insufficiency	Device: Revitive IX Neuromuscular Stimulation Device	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Dosing of Electrical Stimulation in Venous Insufficiency
• Actual Study Start Date: Nov 1, 2015
• Actual Primary Completion Date: Aug 31, 2016
• Actual Study Completion Date: Oct 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Group A No device utilised for 6 weeks.
Experimental: Group B Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 30 mins / day for 6 weeks.	Device: Revitive IX Neuromuscular Stimulation Device; Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence.
Experimental: Group C Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 60 mins / day for 6 weeks.	Device: Revitive IX Neuromuscular Stimulation Device; Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

3. Microcirculatory Blood Flow [0 and 6 weeks.]

   Microcirculatory blood flow measure utilising flux arbitrary units.

4. Limb Volume [0 and 6 weeks]

   Change in limb volume assessed in ml.

5. 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

6. Patient Compliance [6 weeks.]

   Compliance with device usage assessed with a patient completed diary.

7. 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).

8. 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.

9. 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.

10. 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.

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Imperial College London
• Actegy Ltd.

Investigators

• Principal Investigator: Raveena Ravikumar, MRCS, Imperial College London

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT03850496
• Other Study ID Numbers: 15HH2472; 171441; 15/LO/0620
• First Posted: Feb 21, 2019
• Last Update Posted: Jul 31, 2020
• Last Verified: Jul 1, 2020

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

Study Results

Participant Flow

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	No device utilised for 6 weeks.	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.	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.
Period Title: Overall Study
STARTED	26	25	25
COMPLETED	25	24	21
NOT COMPLETED	1	1	4

Baseline Characteristics

Arm/Group Title	Group A	Group B	Group C	Total
Arm/Group Description	No device utilised for 6 weeks.	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.	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.	Total of all reporting groups
Overall Participants	26	25	25	76
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59 (5)	59 (5)	63 (5)	60 (5)
Sex: Female, Male (Count of Participants)
Female	8 30.8%	9 36%	12 48%	29 38.2%
Male	18 69.2%	16 64%	13 52%	47 61.8%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United Kingdom	26 100%	25 100%	25 100%	76 100%

Outcome Measures

1. Primary Outcome

Title	Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	No device utilised for 6 weeks.	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.	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.
Measure Participants	25	24	21
0 weeks	3.36	26.58	39.49
6 weeks	0.46	27.83	36.38

2. Secondary Outcome

Title	Venous Flow Parameters - PV
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	No device utilised for 6 weeks.	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.	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.
Measure Participants	25	24	21
0 Week	-4.760	202.7	151.9
6 Weeks	3.360	145.8	246.6

3. Secondary Outcome

Title	Venous Flow Parameters - VF
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	No device utilised for 6 weeks.	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.	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.
Measure Participants	25	24	21
0 weeks	5.525	28.81	52.82
6 weeks	-6.145	29.11	52.82

4. Secondary Outcome

Title	Microcirculatory Blood Flow
Description	Microcirculatory blood flow measure utilising flux arbitrary units.
Time Frame	0 and 6 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	Limb Volume
Description	Change in limb volume assessed in ml.
Time Frame	0 and 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Venous Clinical Severity
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	No device utilised for 6 weeks.	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.	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.
Measure Participants	25	24	21
0 weeks	6	6	7
6 weeks	7	5	3

7. Secondary Outcome

Title	Patient Compliance
Description	Compliance with device usage assessed with a patient completed diary.
Time Frame	6 weeks.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

8. Secondary Outcome

Title	Generic Quality of Life - EQ-5D-5L
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

9. Secondary Outcome

Title	Generic Quality of Life - SF-12
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

10. Secondary Outcome

Title	Generic Quality of Life - EQ-VAS
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

11. Secondary Outcome

Title	Disease Specific Quality of Life
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Group A	Group B	Group C
Arm/Group Description	No device utilised for 6 weeks.	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.	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.
Measure Participants	25	24	21
0 weeks	18.62	21.07	21.30
6 weeks	19.72	18.86	15.01

Adverse Events

Time Frame	6 months
Arm/Group Title	Group A		Group B		Group C
Arm/Group Description	No device utilised for 6 weeks.		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.		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.
All Cause Mortality
	Group A		Group B		Group C
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/25 (0%)		0/25 (0%)
Serious Adverse Events
	Group A		Group B		Group C
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Group A		Group B		Group C
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/25 (0%)		0/25 (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.