Status:
COMPLETED
DESIVI: Dosing of Electrical Stimulation in Venous Insufficiency
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
Actegy Ltd.
Conditions:
Varicose Veins
Venous Stasis
Eligibility:
All Genders
18+ years
Phase:
NA
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)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2016
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT03850496
Start Date
November 1 2015
End Date
October 31 2016
Last Update
July 31 2020
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.