Peripheral Arterial DiseaseNCT02634138
Neuromuscular Electrical Stimulation in Patients With Critical Limb Ischaemia
A study testing Revitive IX in people with Peripheral Arterial Disease and Critical Limb Ischaemia, run by Imperial College London at 1 site in United Kingdom.
Trial summary
This study will assess the benefit of a neuromuscular electrical stimulation device in patients suffering from symptoms and effects of critical limb ischaemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Critical Limb Ischaemia
- What is being tested?
- Revitive IX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Imperial College London - Charing Cross Hospital
London, W6 8RF
About this study
This study will assess the benefit of a neuromuscular electrical stimulation device in patients suffering from symptoms and effects of critical limb ischaemia.
Read the 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.
- Being tested
- Revitive IX
- Keywords
- Peripheral Vascular Disease, Critical Limb Ischaemia
- Medical subject headings
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revitive IXDevice
A foot plate Neuromuscular Electrical Stimulation Device
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Revitive IX Neuromuscular Electrical Stimulation Device Receives: Device: Revitive IX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score
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
Measured: 6 weeks
Secondary outcomes (7)
Major amputation rate
Identify if and number of major amputations carried out during study period.
Measured: 6 weeks
Flow rate in Femoral Artery
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.
Measured: Day 1 then at 6 weeks
Femoral artery diameter
Duplex ultrasound guided measurement of femoral artery diameter whilst using the device on day 1 and then 6 weeks later during follow up visit.
Measured: Day 1 and at 6 weeks
Disease specific questionnaire - VascuQoL
Change of disease specific Quality of Life (QoL) measure from baseline to 6 weeks.
Measured: Day 1 and at 6 weeks
Short Form - 36 (SF-36)
Change ofSF-36 Quality of Life (QoL) score from Day 1 to 6 weeks.
Measured: Day 1 and at 6 weeks
EuroQol - EQ5D
Change of EQ5D Quality of Life (QoL) score from Day 1 to 6 weeks.
Measured: Day 1 and at 6 weeks
Patient compliance using diary of device use
Check the frequency of device use over the 6 week study period.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Halted prematurely
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alun H Davies, BA BMChB MA, Study chair, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634138
- Sponsor's protocol ID
- 14HH2036
- Status last verified
- Jun 2019
- First submitted
- 1 Dec 2015
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Electrical Stimulation in Patients With Critical Limb Ischaemia
- ClinicalTrials.gov ID
- NCT02634138
- Acronym / sponsor ID
- 14HH2036
- Keywords
- Peripheral Vascular Disease, Critical Limb Ischaemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Halted prematurely
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the benefit of a neuromuscular electrical stimulation device in patients suffering from symptoms and effects of critical limb ischaemia.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Revitive IXRevitive IX Neuromuscular Electrical Stimulation Device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Revitive IXA foot plate Neuromuscular Electrical Stimulation Device | Device | Intervention |
Primary outcome
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
7 secondary outcomes
Major amputation rate
Time frame: 6 weeks
Flow rate in Femoral Artery
Time frame: Day 1 then at 6 weeks
Femoral artery diameter
Time frame: Day 1 and at 6 weeks
Disease specific questionnaire - VascuQoL
Time frame: Day 1 and at 6 weeks
Short Form - 36 (SF-36)
Time frame: Day 1 and at 6 weeks
EuroQol - EQ5D
Time frame: Day 1 and at 6 weeks
Patient compliance using diary of device use
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Halted prematurely). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alun H Davies, BA BMChB MA study chair
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revitive IX in people with Peripheral Arterial Disease and Critical Limb Ischaemia, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Halted prematurely). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.