Peripheral Arterial DiseasePADNCT02136537
Electrical Stimulation in Peripheral Arterial Disease
A study testing Bilateral NMES legs and Best medical therapy in people with Peripheral Arterial Disease, run by Imperial College London at 1 site in United Kingdom.
Trial summary
The investigators wish to investigate the effects of neuromuscular stimulation on intermittent claudication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Bilateral NMES legs and Best medical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Dec 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
- Clinical diagnosis of stable intermittent claudication (>6 months) with confirmation by medical imaging
- ABPI<0.9
- Absolute walking distance <500m
Who cannot join
- Pregnancy
- Cardiac pacemaker
- Previous lower limb major amputation
Trial locations and contacts
1 site in 1 country.
About this study
The investigators wish to investigate the effects of neuromuscular stimulation on intermittent claudication.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Bilateral NMES legs, Best medical therapy
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral NMES legsDevice
Stimulation with the geko(TM) device, Firstkind Ltd, UK. 4 hours per day, bilateral, applied to the skin overlying the common peroneal nerve
Best medical therapyOther
Treated according to local NHS protocol. At Imperial College Healthcare Trust, this will include diagnostic tests (medical interview and examination, ultrasound of blood vessels, diagnostic treadmill test, blood tests and Xrays as appropriate). This also includes lifestyle advice, treatment with appropriate drugs such as aspirin and statins, and supervised exercise.
| Study group | Role | What they receive |
|---|---|---|
| Best medical therapy | Active comparator | Claudicants treated according to local protocol - no added treatment Receives: Other: Best medical therapy |
| Best medical therapy plus NMES | Experimental | In addition to best medical therapy, subjects will receive bilateral neuromuscular stimulation of their legs, 4 hours per day. Receives: Device: Bilateral NMES legs; Other: Best medical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute walking distance
Treadmill test (2mph, 0% grade increased by 3.5% every 3 minutes to a maximum of 15%
Measured: 6 weeks
Secondary outcomes (1)
Claudication distance
Treadmill test (as per absolute walking distance)
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 posted13 May 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: Member of staff moved on to training post. Trial halted and terminated
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- AH Davies, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02136537
- Sponsor's protocol ID
- 14/LO/0854
- Other IDs
- 14HH2054
- Acronym
- PAD
- Status last verified
- May 2019
- First submitted
- 9 May 2014
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrical Stimulation in Peripheral Arterial Disease
- ClinicalTrials.gov ID
- NCT02136537
- Acronym / sponsor ID
- PAD / 14/LO/0854
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Member of staff moved on to training post. Trial halted and terminated
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 May 2014 (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.
The investigators wish to investigate the effects of neuromuscular stimulation on intermittent claudication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Best medical therapy | Active comparator | Other: Best medical therapyClaudicants treated according to local protocol - no added treatment |
| Best medical therapy plus NMES | Experimental | Device: Bilateral NMES legs, Other: Best medical therapyIn addition to best medical therapy, subjects will receive bilateral neuromuscular stimulation of their legs, 4 hours per day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of stable intermittent claudication (>6 months) with confirmation by medical imaging
- ABPI<0.9
- Absolute walking distance <500m
Key exclusion criteria (3 listed)
- Pregnancy
- Cardiac pacemaker
- Previous lower limb major amputation
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 |
|---|---|---|
| Bilateral NMES legsStimulation with the geko(TM) device, Firstkind Ltd, UK. 4 hours per day, bilateral, applied to the skin overlying the common peroneal nerve | Device | Best medical therapy plus NMES |
| Best medical therapyTreated according to local NHS protocol. At Imperial College Healthcare Trust, this will include diagnostic tests (medical interview and examination, ultrasound of blood vessels, diagnostic treadmill test, blood tests and Xrays as appropriate). This also includes lifestyle advice, treatment with appropriate drugs such as aspirin and statins, and supervised exercise. | Other | Best medical therapy, Best medical therapy plus NMES |
Primary outcome
Absolute walking distance
Time frame: 6 weeks
Treadmill test (2mph, 0% grade increased by 3.5% every 3 minutes to a maximum of 15%
1 secondary outcome
Claudication distance
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: Member of staff moved on to training post. Trial halted and terminated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 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.
AH Davies principal investigator
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 Bilateral NMES legs and Best medical therapy in people with Peripheral Arterial Disease, 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 3 inclusion and 3 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 9 May 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: Member of staff moved on to training post. Trial halted and terminated). 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?
Absolute walking distance (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 9 May 2019.