REVITIVE for the Treatment of Patients With Venous Insufficiency (RVI)
Primary Purpose
Venous Insufficiency, Oedema, Varicose Veins
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
REVITIVE IX
Sponsored by
About this trial
This is an interventional treatment trial for Venous Insufficiency focused on measuring electrical stimulation, venous insufficiency, post thrombotic syndrome, varicose veins
Eligibility Criteria
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.
Sites / Locations
- Academic Department of Vascular Surgery, Charing Cross Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
REVITIVE IX: actual device
REVITIVE IX: sham device
Arm Description
Trial participants will receive the true Revitive IX device
Trial participants will receive a sham device
Outcomes
Primary Outcome Measures
Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV
Femoral vein haemodynamics is measured using ultrasound scan - Time Averaged Mean Velocity
Secondary Outcome Measures
Changes in Limb Swelling, Volume
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
Clinical Symptoms
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.
Full Information
NCT ID
NCT02114307
First Posted
April 11, 2014
Last Updated
September 20, 2019
Sponsor
Imperial College London
Collaborators
Actegy Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02114307
Brief Title
REVITIVE for the Treatment of Patients With Venous Insufficiency
Acronym
RVI
Official Title
REVITIVE for the Treatment of Patients With Venous Insufficiency
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2014 (Actual)
Primary Completion Date
October 1, 2014 (Actual)
Study Completion Date
October 1, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
Actegy Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To investigate the efficacy of an electrical stimulation (using the REVITIVE IX device) in treating patients with venous insufficiency.
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:
a) improvement in venous haemodynamics.
Secondary outcome measures:
improvement in lower limb oedema
improvement in clinical symptoms
reduction in lower limb pain and discomfort
improvement in quality of life measures
device satisfaction.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Insufficiency, Oedema, Varicose Veins
Keywords
electrical stimulation, venous insufficiency, post thrombotic syndrome, varicose veins
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
REVITIVE IX: actual device
Arm Type
Active Comparator
Arm Description
Trial participants will receive the true Revitive IX device
Arm Title
REVITIVE IX: sham device
Arm Type
Sham Comparator
Arm Description
Trial participants will receive a sham device
Intervention Type
Device
Intervention Name(s)
REVITIVE IX
Intervention Description
neuromuscular electrical stimulation device
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alun Davies, MA DM FRCS FHEA
Organizational Affiliation
Imperial College London and Imperial College London NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Department of Vascular Surgery, Charing Cross Hospital
City
London
ZIP/Postal Code
W4 8RF
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data available on request.
IPD Sharing Time Frame
12 Months after publication of main study
IPD Sharing Access Criteria
From listed authors.
Citations:
PubMed Identifier
27919609
Citation
Ravikumar R, Williams KJ, Babber A, Lane TRA, Moore HM, Davies AH. Randomised Controlled Trial: Potential Benefit of a Footplate Neuromuscular Electrical Stimulation Device in Patients with Chronic Venous Disease. Eur J Vasc Endovasc Surg. 2017 Jan;53(1):114-121. doi: 10.1016/j.ejvs.2016.09.015. Epub 2016 Dec 2.
Results Reference
result
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REVITIVE for the Treatment of Patients With Venous Insufficiency
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