Recruitment

Recruitment Status
Completed

Summary

Conditions
  • Chronic Venous Disease
  • Deep Venous Obstruction
  • Venous Insufficiency
Type
Interventional
Design
  • Allocation: Non-Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Min Age
18
Max Age
125
Gender
Both

Description

STUDY AIMS To obtain ultrasound blood flow and velocity measurements in the leg to compare the hemodynamic profiles obtained using a neuromuscular stimulation device with those obtained at rest. To ascertain if a 6 week protocol of electrical neurostimulation of the muscle pumps in the leg and foot ...

STUDY AIMS To obtain ultrasound blood flow and velocity measurements in the leg to compare the hemodynamic profiles obtained using a neuromuscular stimulation device with those obtained at rest. To ascertain if a 6 week protocol of electrical neurostimulation of the muscle pumps in the leg and foot can reduce clinical symptoms and improve quality of life. METHODS Controlled interventional trial. Group 1 (10 subjects) will be healthy subjects with no clinical venous disease. Subjects with venous incompetence to be recruited into one of three groups. Group 2 (10 subjects) will have superficial venous incompetence; Group 3 (10 subjects) will have deep venous incompetence; Group 4 (10 subjects) will have deep vein occlusion. These will be clinical diagnoses confirmed with duplex ultrasound. The device used in this study will be the geko™ T-1 device (Firstkind Ltd, UK). A geko™ device will be fitted to each leg. The device stimulation level is set to the minimum level that can achieve the desired response (outward and upward twitching of the foot when raised from the ground). ENDPOINTS Primary end-point Increase in venous flow Secondary end points Improvement in clinical symptoms at 6 weeks, as judged by questionnaire Reduction in absolute leg diameter and volume at 6 weeks

Locations

Hammersmith, London, W6 8RF
Hammersmith, London, W6 8RF

Tracking Information

NCT #
NCT02137499
Collaborators
Not Provided
Investigators
  • Principal Investigator: Alun Davies Imperial College London
  • Alun Davies Imperial College London