Neuromuscular Electrical Stimulation in Patients With Critical Limb Ischaemia

June 4, 2019 updated by: Imperial College London
This study will assess the benefit of a neuromuscular electrical stimulation device in patients suffering from symptoms and effects of critical limb ischaemia.

Study Overview

Status

Terminated

Intervention / Treatment

Detailed Description

The circulation of blood around the body is dependent on effective pumping of the heart. Patients with arterial insufficiency are known to have poor circulation in their lower legs and feet leading to various complications such as swelling and painful legs and reduced healing of injuries.

Peripheral arterial disease (PAD) can be defined as a narrowing of the arteries reducing blood flow. It is most commonly due to atherosclerosis, and has associations with heart disease, stroke, and diabetes. Its incidence is estimated at 7-14% in the general population, increasing with age to about 20% in the over-seventies. It is associated with effects on mobility, skin condition and quality of life. Symptoms include pain in the legs on walking (intermittent claudication), pain at rest (particularly at night), gangrene, and limb loss. Management of PAD is based on encouraging exercise, and modification of risk factors such as smoking, high blood pressure, high cholesterol and diabetes.

In patients with PAD, exercise tolerance is often limited. Severe symptoms and disease can be treated via such as balloon angioplasty, stenting or surgical bypass, but these procedures have risk. There also remains a percentage of patients who are not suitable for revascularisation, and have only a few options such as amputation available to them.

Some trials have shown that increasing the blood flow in the legs over time using medical devices (intermittent pneumatic compression, muscle stimulators), in addition to maximal medical and surgical therapy, can increase claudication distance, absolute walking distance, decrease rest pain, and reduce amputation rates. In the investigators unit it has become apparent that there are an increasing number of medical devices available for circulatory support, either as an inpatient, out-patient, or a member of the general public. The supporting evidence for these is variable in scientific and clinical content or relevance, and requires clinical trials to evaluate further.

Revitive activates the pumping action of leg muscles by providing electrical muscle stimulation to cause foot muscle contraction and relaxation which squeezes blood back towards the heart, improving circulation.

The investigators wish to evaluate whether NMES using this device has the same beneficial effects in patients with critical limb ischaemia.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • London, United Kingdom, W6 8RF
        • Imperial College London - Charing Cross Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Willing, able, and committed to participate in the procedures for the full length of the study.
  • All ethnic groups, male or female above the age of 18 years.
  • Diagnosis of non-reconstructable arterial disease and critical limb ischaemia (with a minimum of duplex ultrasound and an MDT discussion to have reached this diagnosis)
  • 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 (< 160/100mmHg)
  • History of uncomplicated cardiovascular events beyond 3 months.
  • No current foot ulceration

Exclusion Criteria:

Patients meeting any of the following criteria are to be excluded:

  • Has an unstable condition (eg, psychiatric disorder, a recent history of substance abuse) or otherwise thought to be unreliable or incapable of complying with the study protocol.
  • Has any metal implants
  • Pregnant
  • Has peripheral neuropathy
  • 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
  • Ankle-Brachial Pressure Index >0.9

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Revitive IX Neuromuscular Electrical Stimulation Device
A foot plate Neuromuscular Electrical Stimulation Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: 6 weeks
Change in pain score with device use over a 6 week period. Measure by a visual analogue scale of pain with 0 = no pain and 10 = maximum pain
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major amputation rate
Time Frame: 6 weeks
Identify if and number of major amputations carried out during study period.
6 weeks
Flow rate in Femoral Artery
Time Frame: Day 1 then at 6 weeks
Duplex ultrasound guided measurement of femoral artery flow rate whilst using the device on day 1 and then 6 weeks later during follow up visit.
Day 1 then at 6 weeks
Femoral artery diameter
Time Frame: Day 1 and at 6 weeks
Duplex ultrasound guided measurement of femoral artery diameter whilst using the device on day 1 and then 6 weeks later during follow up visit.
Day 1 and at 6 weeks
Disease specific questionnaire - VascuQoL
Time Frame: Day 1 and at 6 weeks
Change of disease specific Quality of Life (QoL) measure from baseline to 6 weeks.
Day 1 and at 6 weeks
Short Form - 36 (SF-36)
Time Frame: Day 1 and at 6 weeks
Change ofSF-36 Quality of Life (QoL) score from Day 1 to 6 weeks.
Day 1 and at 6 weeks
EuroQol - EQ5D
Time Frame: Day 1 and at 6 weeks
Change of EQ5D Quality of Life (QoL) score from Day 1 to 6 weeks.
Day 1 and at 6 weeks
Patient compliance using diary of device use
Time Frame: 6 weeks
Check the frequency of device use over the 6 week study period.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

December 1, 2015

First Submitted That Met QC Criteria

December 15, 2015

First Posted (Estimate)

December 17, 2015

Study Record Updates

Last Update Posted (Actual)

June 6, 2019

Last Update Submitted That Met QC Criteria

June 4, 2019

Last Verified

June 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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