DESIVI: Dosing of Electrical Stimulation in Venous Insufficiency

Imperial College London

Status: Completed

Conditions: Venous Insufficiency; Venous Stasis; Varicose Veins

Treatments: Device: Revitive IX Neuromuscular Stimulation Device

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03850496

15HH2472

15/LO/0620 (Other Identifier)

171441 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76 participants in 3 patient groups

Group A

No Intervention group

Description:

No device utilised for 6 weeks.

Group B

Experimental group

Description:

Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 30 mins / day for 6 weeks.

Treatment:

Device: Revitive IX Neuromuscular Stimulation Device

Group C

Experimental group

Description:

Revitive IX Neuromuscular Stimulation Device - Neuromuscular stimulation device used for 60 mins / day for 6 weeks.

Treatment:

Device: Revitive IX Neuromuscular Stimulation Device