N/A
N=21
Neuromuscular Electrical Stimulation (NMES) in Patients With Intermittent Claudication
Intermittent Claudication · Peripheral Vascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT02436200 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Change From Baseline in Initial Walking Distance — 64.3 metres
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Neuromuscular Electrical Stimulation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Initial Walking Distance |
64.3 | — |
| PRIMARY Absolute Walking Distance Measured by Treadmill |
130 | — |
| SECONDARY Femoral Haemodynamics Measured by Femoral Artery Duplex Ultrasonography |
— | — |
| SECONDARY Laser Doppler Flow Measured by Optical Laser |
— | — |
| SECONDARY Symptomatic Scores by Questionnaire |
— | — |
| SECONDARY Quality of Life Scores Measured by Questionnaire |
— | — |
| SECONDARY Urine Metabolic Profile |
— | — |
| SECONDARY Serum Metabolic Profile |
— | — |
Summary
This study will assess the benefit of a neuromuscular electrical stimulation device in patients suffering from symptoms and effects of lower limb intermittent claudication.
Eligibility Criteria
Inclusion Criteria
- All ethnic groups, male or female above the age of 18 years.
- Diagnosis of mild intermittent claudication
- Be of non-childbearing potential; OR using adequate contraception and have a negative urine pregnancy test result within 24 hours if appropriate before using the study device.
- Blood pressure currently under moderate control ( 0.9
- Has any metal implants
- Pregnant
- Has a cardiac pacemaker or defibrillator device
- Has recent lower limb injury or lower back pain
- Has current foot ulceration or other skin ulcers
- Has foot deformities
- Has any disorder that, in the opinion of the Investigator, might interfere with the conduct of the study.
Data sourced from ClinicalTrials.gov (NCT02436200). 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.