DESIVI: Dosing of Electrical Stimulation in Venous Insufficiency

NCT ID: NCT03850496

Last Updated: 2020-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-01
• Study Completion Date: 2016-10-31

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.

Conditions

Varicose Veins; Venous Stasis; Venous Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

No device utilised for 6 weeks.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Group B

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

Group Type: EXPERIMENTAL

Revitive IX Neuromuscular Stimulation Device

Intervention Type: DEVICE

Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence.

Group C

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

Group Type: EXPERIMENTAL

Revitive IX Neuromuscular Stimulation Device

Intervention Type: DEVICE

Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence.

Interventions

Revitive IX Neuromuscular Stimulation Device

Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Actegy Ltd.

INDUSTRY

Sponsor Role: collaborator

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raveena Ravikumar, MRCS

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Other Identifiers

171441

Identifier Type: OTHER

Identifier Source: secondary_id

15/LO/0620

Identifier Type: OTHER

Identifier Source: secondary_id

15HH2472

Identifier Type: -

Identifier Source: org_study_id