N/A
N=40
Venous Insufficiency and Neuromuscular Stimulation
Chronic Venous Disease · Venous Insufficiency · Deep Venous Obstruction
Bottom Line
View on ClinicalTrials.gov: NCT02137499 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Percentage Change of Haemodynamic Flow — 34.8; 62.8; 9; 14.8 % change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- geko device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change of Haemodynamic Flow |
34.8; 62.8; 9; 14.8; -14.2; 28.1 | — |
| SECONDARY Improvement in Venous Symptoms |
— | — |
| SECONDARY Leg Volume |
— | — |
Summary
The investigators will be evaluating the immediate and longer term effect of treatment with a medical device on the symptoms of chronic venous disease.
Eligibility Criteria
Group 1
- Inclusion criteria - 18+ years old, 17<BMI<30
- Exclusion criteria - Heart/lung/kidney failure, pregnancy, diagnosis of peripheral vascular disease, previous VTE, ABPI<0.9, active infection, previous leg fracture or metal implant in leg
Group 2
- Inclusion criteria - 18+ years old, 17<BMI<30, clinical diagnosis of superficial venous insufficiency (CEAP C2-6) confirmed with duplex US
- Exclusion criteria - Heart/lung/kidney failure, pregnancy, ABPI<0.9, active infection, previous leg fracture or metal implant in leg
Group 3
- Inclusion criteria - 18+ years old, 17<BMI<30, clinical diagnosis of deep venous insufficiency (CEAP C2-6) confirmed with duplex US
- Exclusion criteria - Heart/lung/kidney failure, pregnancy, ABPI<0.9, active infection, previous leg fracture or metal implant in leg
Group 4
- Inclusion criteria - 18+ years old, 17<BMI<30, clinical diagnosis of deep venous obstruction confirmed with duplex US
- Exclusion criteria - Heart/lung/kidney failure, pregnancy, ABPI<0.9, active infection, previous leg fracture or metal implant in leg
Data sourced from ClinicalTrials.gov (NCT02137499). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.