Intermittent Pneumatic CompressionNCT01939288
Effect of Neuromuscular Calf Stimulation and Intermittent Pneumatic Compression on Lower Limb Venous Hemodynamics
A study testing Neuromuscular stimulation, followed by intermittent pneumatic compression and Intermittent pneumatic compression, followed by neuromuscular stimulation in people with Intermittent Pneumatic Compression, run by Imperial College London at 1 site in United Kingdom.
Trial summary
What is known? Disorders of peripheral circulation result in vascular morbidity and mortality Augmentation of peripheral circulation has been shown to be of benefit in both venous and arterial disease The benefit of intermittent pneumatic compression is clinically well evidenced. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Intermittent Pneumatic Compression
- What is being tested?
- Neuromuscular stimulation, followed by intermittent pneumatic compression and Intermittent pneumatic compression, followed by neuromuscular stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Age >18 yrs, Body Mass Index (BMI) 17-30Kg/m2
Who cannot join
- History of heart disease or respiratory disorder, pregnancy, history of peripheral vascular disease or previous thromboembolic event, ABPI< 0.9, cardiac pacemaker, history of leg fractures and/or presence of metal implants in the leg, long distance travel within one week prior to study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Academic Vascular Surgery, Charing Cross Hospital
London, W6 8RF
About this study
What is known?
- Disorders of peripheral circulation result in vascular morbidity and mortality
- Augmentation of peripheral circulation has been shown to be of benefit in both venous and arterial disease
- The benefit of intermittent pneumatic compression is clinically well evidenced.
- The use of intermittent pneumatic compression is limited by compliance issues related to sleeve application and external power source.
What new information will this trial contribute?
- This evaluates the haemodynamic effect of a new electrical device for augmentation of peripheral circulation
Read the detailed description
RATIONALE - Enhancement of peripheral circulation has been shown to be of benefit in many vascular disorders, and the clinical effectiveness of intermittent pneumatic compression (IPC) is well established in peripheral vascular disease.
OBJECTIVE - This study aims to compare the haemodynamic efficacy of a novel neuromuscular electrical stimulation (NMES) device with IPC in healthy subjects.
METHODS - 10 healthy volunteers will be randomised into two groups, in an interventional cross-over trial. Baseline measurements of haemodynamic velocity and flow will be taken, then subjects given bilateral therapy with each of the two devices in turn. Laser doppler fluximetry readings will be taken from the hand and foot. Baseline readings will be compared with readings taken after immediate cessation of therapy, and after 10 minutes. Tolerability will be measured using a verbal reported score.
- Conditions
- Intermittent Pneumatic Compression
- Being tested
- Neuromuscular stimulation, followed by intermittent pneumatic compression, Intermittent pneumatic compression, followed by neuromuscular stimulation
- Keywords
- neuromuscular stimulation, intermittent pneumatic compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular stimulation, followed by intermittent pneumatic compressionDevice
Also called Device 1 followed by a break, followed by device 2
Intermittent pneumatic compression, followed by neuromuscular stimulationDevice
Also called Device 2, followed by a short break then device 2
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Half of recruited subjects (n=5) Receives: Device: Neuromuscular stimulation, followed by intermittent pneumatic compression |
| Group 2 | Experimental | Other half of recruited subjects (n=5) Receives: Device: Intermittent pneumatic compression, followed by neuromuscular stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
IPC(on) Peak Velocity Change From Baseline
Ultrasound measurements of peak velocity. This is taken from the left leg superficial femoral vein and artery
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intermittent Pneumatic CompressionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kate Williams, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939288
- Sponsor's protocol ID
- JROHH0324
- Status last verified
- Sep 2019
- First submitted
- 8 Aug 2013
- Last updated
- 20 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Williams KJ, Moore HM, Davies AH. Haemodynamic changes with the use of neuromuscular electrical stimulation compared to intermittent pneumatic compression. Phlebology. 2015 Jun;30(5):365-72. doi: 10.1177/0268355514531255. Epub 2014 Apr 10.
PubMed 24722790
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neuromuscular Calf Stimulation and Intermittent Pneumatic Compression on Lower Limb Venous Hemodynamics
- ClinicalTrials.gov ID
- NCT01939288
- Acronym / sponsor ID
- JROHH0324
- Conditions
- Intermittent Pneumatic Compression
- Keywords
- neuromuscular stimulation, intermittent pneumatic compression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Dec 2012 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Sep 2013 (estimated)
- Results
- Posted 22 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
What is known?
- Disorders of peripheral circulation result in vascular morbidity and mortality
- Augmentation of peripheral circulation has been shown to be of benefit in both venous and arterial disease
- The benefit of intermittent pneumatic compression is clinically well evidenced.
- The use of intermittent pneumatic compression is limited by compliance issues related to sleeve application and external power source.
What new information will this trial contribute?
- This evaluates the haemodynamic effect of a new electrical device for augmentation of peripheral circulation
Detailed description
RATIONALE - Enhancement of peripheral circulation has been shown to be of benefit in many vascular disorders, and the clinical effectiveness of intermittent pneumatic compression (IPC) is well established in peripheral vascular disease.
OBJECTIVE - This study aims to compare the haemodynamic efficacy of a novel neuromuscular electrical stimulation (NMES) device with IPC in healthy subjects.
METHODS - 10 healthy volunteers will be randomised into two groups, in an interventional cross-over trial. Baseline measurements of haemodynamic velocity and flow will be taken, then subjects given bilateral therapy with each of the two devices in turn. Laser doppler fluximetry readings will be taken from the hand and foot. Baseline readings will be compared with readings taken after immediate cessation of therapy, and after 10 minutes. Tolerability will be measured using a verbal reported score.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Neuromuscular stimulation, followed by intermittent pneumatic compressionHalf of recruited subjects (n=5) |
| Group 2 | Experimental | Device: Intermittent pneumatic compression, followed by neuromuscular stimulationOther half of recruited subjects (n=5) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Age >18 yrs, Body Mass Index (BMI) 17-30Kg/m2
Key exclusion criteria (1 listed)
- History of heart disease or respiratory disorder, pregnancy, history of peripheral vascular disease or previous thromboembolic event, ABPI< 0.9, cardiac pacemaker, history of leg fractures and/or presence of metal implants in the leg, long distance travel within one week prior to study
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 |
|---|---|---|
| Neuromuscular stimulation, followed by intermittent pneumatic compressionAlso: Device 1 followed by a break, followed by device 2 | Device | Group 1 |
| Intermittent pneumatic compression, followed by neuromuscular stimulationAlso: Device 2, followed by a short break then device 2 | Device | Group 2 |
Primary outcome
IPC(on) Peak Velocity Change From Baseline
Time frame: One day
Ultrasound measurements of peak velocity. This is taken from the left leg superficial femoral vein and artery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24722790Williams KJ, Moore HM, Davies AH. Haemodynamic changes with the use of neuromuscular electrical stimulation compared to intermittent pneumatic compression. Phlebology. 2015 Jun;30(5):365-72. doi: 10.1177/0268355514531255. Epub 2014 Apr 10.
- PI informationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Kate Williams 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 Neuromuscular stimulation, followed by intermittent pneumatic compression and Intermittent pneumatic compression, followed by neuromuscular stimulation in people with Intermittent Pneumatic Compression, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Sep 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?
Yes. Results are posted in the registry (first posted 22 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
IPC(on) Peak Velocity Change From Baseline (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01939288, which also lists 1 linked publication.
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 20 Sep 2019.