N/A
N=76
DESIVI: Dosing of Electrical Stimulation in Venous Insufficiency
Varicose Veins · Venous Stasis · Venous Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT03850496 ↗Enrolled (actual)
76
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV — 3.36; 26.58; 39.49; 0.46 percentage change from device off
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Revitive IX Neuromuscular Stimulation Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Venous Haemodynamics - Percent Change in Time Averaged Mean Velocity TAMV |
3.36; 26.58; 39.49; 0.46; 27.83; 36.38 | — |
| SECONDARY Venous Flow Parameters - PV |
-4.760; 202.7; 151.9; 3.360; 145.8; 246.6 | — |
| SECONDARY Venous Flow Parameters - VF |
5.525; 28.81; 52.82; -6.145; 29.11; 52.82 | — |
| SECONDARY Microcirculatory Blood Flow |
— | — |
| SECONDARY Limb Volume |
— | — |
| SECONDARY Venous Clinical Severity |
6; 6; 7; 7; 5; 3 | — |
| SECONDARY Patient Compliance |
— | — |
| SECONDARY Generic Quality of Life - EQ-5D-5L |
— | — |
| SECONDARY Generic Quality of Life - SF-12 |
— | — |
| SECONDARY Generic Quality of Life - EQ-VAS |
— | — |
| SECONDARY Disease Specific Quality of Life |
18.62; 21.07; 21.30; 19.72; 18.86; 15.01 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03850496). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.