RVI: REVITIVE for the Treatment of Patients With Venous Insufficiency

• Sponsor: Imperial College London (Other)
• Overall Status: Completed
• CT.gov ID: NCT02114307
• Collaborator: Actegy Ltd. (Industry)
• Enrollment: 22
• Location: 1
• Arms: 2
• Actual Duration (Months): 7
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief Summary

To investigate the efficacy of an electrical stimulation (using the REVITIVE IX device) in treating patients with venous insufficiency.

Condition or Disease	Intervention/Treatment	Phase
Venous Insufficiency; Oedema; Varicose Veins	Device: REVITIVE IX	N/A

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:

1. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: REVITIVE for the Treatment of Patients With Venous Insufficiency
• Actual Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Oct 1, 2014
• Actual Study Completion Date: Oct 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: REVITIVE IX: actual device Trial participants will receive the true Revitive IX device	Device: REVITIVE IX; neuromuscular electrical stimulation device
Sham Comparator: REVITIVE IX: sham device Trial participants will receive a sham device	Device: REVITIVE IX; neuromuscular electrical stimulation device

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. 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.

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Academic Department of Vascular Surgery, Charing Cross Hospital	London		United Kingdom	W4 8RF

Sponsors and Collaborators

• Imperial College London
• Actegy Ltd.

Investigators

• Principal Investigator: Alun Davies, MA DM FRCS FHEA, Imperial College London and Imperial College London NHS Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Imperial College London
• ClinicalTrials.gov Identifier: NCT02114307
• Other Study ID Numbers: 13HH0768
• First Posted: Apr 15, 2014
• Last Update Posted: Oct 10, 2019
• Last Verified: Sep 1, 2019

• 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: electrical stimulation; venous insufficiency; post thrombotic syndrome; varicose veins
• Additional relevant MeSH terms: Venous Insufficiency; Varicose Veins

Study Results

Participant Flow

Recruitment Details	Recruitment from vascular outpatients clinic between 20/02/2014 - 18/09/2014.
Pre-assignment Detail	Patient stayed in the full length of the study. Chronic venous insufficiency (C2-C5 CEAP). Blood pressure <160/100mmHg. No current foot ulceration

Arm/Group Title	REVITIVE IX: Actual Device	REVITIVE IX: Sham Device
Arm/Group Description	Trial participants will receive the true Revitive IX device REVITIVE IX: neuromuscular electrical stimulation device	Trial participants will receive a sham device REVITIVE IX: sham device
Period Title: Overall Study
STARTED	11	11
COMPLETED	10	11
NOT COMPLETED	1	0

Baseline Characteristics

Arm/Group Title	Test Device	Sham Device	Total
Arm/Group Description	Patients received the REVITIVE IX device for 6 weeks of home usage.	Sham REVITIVE IX for 6 weeks of home usage.	Total of all reporting groups
Overall Participants	11	11	22
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	70.0 (12.4)	54.6 (13.7)	62.3 (13.0)
Sex: Female, Male (Count of Participants)
Female	7 63.6%	8 72.7%	15 68.2%
Male	4 36.4%	3 27.3%	7 31.8%
Region of Enrollment (participants) [Number]
United Kingdom	11 100%	11 100%	22 100%

Outcome Measures

1. Primary Outcome

Title	Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV
Description	Femoral vein haemodynamics is measured using ultrasound scan - Time Averaged Mean Velocity
Time Frame	0 and 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	REVITIVE IX: Actual Device	REVITIVE IX: Sham Device
Arm/Group Description	Trial participants will receive the true Revitive IX device REVITIVE IX: neuromuscular electrical stimulation device	Trial participants will receive a sham device REVITIVE IX: neuromuscular electrical stimulation device
Measure Participants	10	11
Mean (Standard Deviation) [percentage change]	102.4 (50)	-9.1 (50)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	REVITIVE IX: Actual Device, REVITIVE IX: Sham Device
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Secondary Outcome

Title	Changes in Limb Swelling, Volume
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Test Device	Sham Device
Arm/Group Description	Patients received the REVITIVE IX device for 6 weeks of home usage.	Sham REVITIVE IX for 6 weeks of home usage.
Measure Participants	10	11
week 0 prestimulation	5377 (1122)	5107 (1252)
week 0 poststimulation	5422 (1127)	5208 (1252)
week 6 prestimulation	5500 (1173)	5143 (1269)
week 6 post stimulation	5553 (1168)	5203 (1272)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	REVITIVE IX: Sham Device
	Comments	Sham Group - 6 week Time Point - Pre-stimulation versus Post-Stimulation
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0023
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	REVITIVE IX: Actual Device
	Comments	Test Group - 6 week Time Point - Pre-stimulation versus Post-Stimulation
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0815
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Clinical Symptoms
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	REVITIVE IX: Actual Device	REVITIVE IX: Sham Device
Arm/Group Description	Trial participants will receive the true Revitive IX device REVITIVE IX: neuromuscular electrical stimulation device	Trial participants will receive a sham device REVITIVE IX: neuromuscular electrical stimulation device
Measure Participants	11	10
Mean (Standard Deviation) [Percentage change in VCSS score]	-11.8 (31.2)	6.4 (20.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	REVITIVE IX: Actual Device, REVITIVE IX: Sham Device
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.127
	Comments
	Method	t-test, 1 sided
	Comments

Adverse Events

Arm/Group Title	REVITIVE IX: Actual Device		REVITIVE IX: Sham Device
Arm/Group Description	Trial participants will receive the true Revitive IX device REVITIVE IX: neuromuscular electrical stimulation device		Trial participants will receive a sham device REVITIVE IX: sham device
All Cause Mortality
	REVITIVE IX: Actual Device		REVITIVE IX: Sham Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)
Serious Adverse Events
	REVITIVE IX: Actual Device		REVITIVE IX: Sham Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (0%)
Other (Not Including Serious) Adverse Events
	REVITIVE IX: Actual Device		REVITIVE IX: Sham Device
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/11 (0%)		0/11 (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.