N/A N=42 Randomized Treatment

Adjuvant Benefit of NMES to Supervised Exercise in Patients With IC

Intermittent Claudication · Peripheral Vascular Disease · Lower Limb Arterial Disease

Bottom Line

View on ClinicalTrials.gov: NCT02429310 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2019

Primary outcome: Primary: Initial Walking Distance Measured by Treadmill — 65.60; 95.50 metres

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Revitive IX (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Imperial College London
Primary completion: Oct 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Initial Walking Distance Measured by Treadmill	65.60; 95.50	—
PRIMARY Absolute Walking Distance Measured by Treadmill	146.7; 167.4	—
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 adjuvant benefit of a neuromuscular electrical stimulation device to standard treatment of supervised exercise in patients suffering from symptoms and effects of lower limb Intermittent Claudication.

Eligibility Criteria

Inclusion Criteria

Patients with intermittent claudication who have the following are eligible for the study:
All ethnic groups, male or female above the age of 18 years.
Diagnosis of 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02429310). 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.