At a glance
ClinicalIndex Comparison RecordN/ACompleted· 76 enrolled
Drug / intervention
Revitive IX Neuromuscular Stimulation Devicedevice
Likely dose
Revitive IX neuromuscular stimulation device with 30-minute pre-programmed varying electrical stimulation sequenceAI-extracted
Key inclusion· 5
- ✓Diagnosis of chronic venous insufficiency classified as C3-C5 on CEAP scale
- ✓Age 18 years or older
- ✓Blood pressure currently under moderate control
- ✓No current foot ulceration
Key exclusion· 7
- ✕Pregnant
- ✕Has cardiac pacemaker, AICD, or other implanted electrical device
- ✕Existing deep vein thrombosis (DVT)
- ✕Recent lower limb injury or lower back pain
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Dosing of Electrical Stimulation in Venous Insufficiency
In Brief
A clinical study evaluating Revitive IX Neuromuscular Stimulation Device for Varicose Veins and 2 related conditions. Completed, enrolled 76 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaricose Veins, Venous Stasis, Venous Insufficiency
Countries--
CollaboratorsActegy Ltd.
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartNov 2015
Primary CompletionAug 2016
Study CompletionOct 2016
First PostedFeb 2019
TodayJul 2026
First PostedFeb 21, 2019
Enrollment StartNov 1, 2015
Primary CompletionAug 31, 2016
Study CompletionOct 31, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.4 years ago
Interventions
Revitive IX Neuromuscular Stimulation Devicedevice
Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence.