N/A
Completed N=21
Neuromuscular Electrical Stimulation (NMES) in Patients With Intermittent Claudication
Intermittent Claudication · Peripheral vascular disease
Source: ClinicalTrials.gov NCT02436200 ↗
Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Change From Baseline in Initial Walking Distance — 64.3 metres
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.
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 |
— | — |
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. Informational only — not medical advice.