Venous StasisNCT03420625
Blood Flow Stimulation in the Lower Limbs by Application of Different External Devices
A study testing Foot IPC, Rapid calf IPC and Slow calf IPC in people with Venous Stasis and Deep Vein Thrombosis, run by Karolinska University Hospital.
Trial summary
In this study, four different devices which stimulate the blood in the lower extremities are used in ten healthy persons while measuring the blood flow with ultrasound. The aim is to study the haemodynamic effects in the lower extremities of each modality and also to compare those effects between the four modalities… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Venous Stasis, Deep Vein Thrombosis
- What is being tested?
- Foot IPC, Rapid calf IPC and Slow calf IPC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Feb 2017
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers
Who cannot join
- pregnancy
- previous lower limb operation involving the vascular system
- current thromboprophylactic or thrombolytic therapy
- vascular abnormalities in the lower limbs
- cardiorespiratory or renal failure causing pitting oedema
About this study
Official title: Haemodynamic Effects of Different Mechanical Compression Devices and Neuromuscular Stimulation in the Lower Limb
In this study, four different devices which stimulate the blood in the lower extremities are used in ten healthy persons while measuring the blood flow with ultrasound. The aim is to study the haemodynamic effects in the lower extremities of each modality and also to compare those effects between the four modalities in order to identify those which most effective than the others.
Read the detailed description
Three Intermittent Pneumatic Compression (IPC) devices were selected: Foot-IPC, rapid Calf-IPC and a slow, sequential Calf-IPC. A Neuromuscular Electrical Stimulation (NMES) device was also used in the calf. Blood flow measurements in the right popliteal vein of ten healthy individuals were performed using Doppler ultrasound before (control) and while using IPC or NMES. The blood flow parameters measured where: peak systolic velocity (cm/s), time-averaged mean velocity (cm/sec), volume flow (ml/min) and ejected volume per individual stimulus (ml). The tolerability of each device was also assessed using an analogue scale from zero to ten. Differences between modalities regarding the pattern as well as the absolute values of velocity and volume are being assessed. Power calculation: Recent studies showed that the peak venous velocity (PV) at baseline is around 11 cm/s and after applying foot-IPC the PV rises to 50 cm/s with a maximum standard deviation of 15 (Broderick et all, 2014). Thus, three patients per group would be required to detect a difference of 39 cm/s in PV (two-sided type-I error rate = 5%; power = 80%). To reach an even higher power we choose to include 10 patients in study, which resulted in a power of 99.7% for the above calculation.
- Conditions
- Venous Stasis, Deep Vein Thrombosis
- Being tested
- Foot IPC, Rapid calf IPC, Slow calf IPC, Calf NMES
- Keywords
- Intermittent Pneumatic Compression Devices, Electric Stimulation Therapy, Blood Flow Velocity, Hemodynamics
- Medical subject headings
- Varicose Ulcer, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foot IPCDevice
Also called Intermittent pneumatic compression in the foot
Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA
Rapid calf IPCDevice
Also called Rapid Intermittent pneumatic compression in the calf
Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA
Slow calf IPCDevice
Also called Slow Intermittent pneumatic compression in the calf
Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA
Calf NMESDevice
Also called Calf neuromuscular electrical stimulation
Neuromuscular electrical stimulation in the calf using the DJOTM, CefarCompex Mi-Theta 500 stimulator
| Study group | Role | What they receive |
|---|---|---|
| Foot IPC | Active comparator | Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA Receives: Device: Foot IPC |
| Rapid calf IPC | Active comparator | Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA Receives: Device: Rapid calf IPC |
| Slow calf IPC | Active comparator | Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA Receives: Device: Slow calf IPC |
| Calf NMES | Active comparator | Neuromuscular electrical stimulation in the calf using the DJO,TM, CefarCompex Mi-Theta 500 stimulator Receives: Device: Calf NMES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Flow - Peak Systolic Velocity (cm/Sec)
With the use of Doppler Ultrasound Peak systolic velocity (cm/sec) is assessed in the popliteal vein.
Measured: up to one hour in total
Blood Flow - Time-averaged Mean Velocity (cm/Sec)
With the use of Doppler Ultrasound Time-averaged mean velocity (cm/sec) is assessed in the popliteal vein.
Measured: up to one hour in total
Blood Flow - Volume Flow (ml/Min)
With the use of Doppler Ultrasound Volume flow (ml/min), is assessed in the popliteal vein.
Measured: up to one hour in total
Blood Flow - Ejected Volume Per Individual Stimulus (ml)
With the use of Doppler Ultrasound Ejected volume per individual stimulus (ml) is assessed in the popliteal vein.
Measured: up to one hour in total
Secondary outcomes (1)
Tolerability to IPC and NMES According to Visual Analogue Scale 0-10
All subjects will be asked to subjectively grade each modality according to how comfortable or uncomfortable it felt under the time was applied to the subject according to Visual Analogue Scale 0-10. The following description will be given to the subjects: 0 denotes the the modality was totally intolerable, 10 denotes that the modality is very pleasant to use and 5 denotes neither pleasant nor unpleasant feeling.
Measured: one minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study startSep 2016
- Primary completionJan 2017
- Study completionFeb 2017
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.
- Other trials for Venous StasisStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Ackermann, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420625
- Sponsor's protocol ID
- SW2016-17-HEMOD
- Status last verified
- Sep 2020
- First submitted
- 8 Feb 2017
- Last updated
- 23 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemodynamic Effects of Different Mechanical Compression Devices and Neuromuscular Stimulation in the Lower Limb
- ClinicalTrials.gov ID
- NCT03420625
- Acronym / sponsor ID
- SW2016-17-HEMOD
- Conditions
- Venous Stasis, Deep Vein Thrombosis
- Keywords
- Intermittent Pneumatic Compression Devices, Electric Stimulation Therapy, Blood Flow Velocity, Hemodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Posted 12 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, four different devices which stimulate the blood in the lower extremities are used in ten healthy persons while measuring the blood flow with ultrasound. The aim is to study the haemodynamic effects in the lower extremities of each modality and also to compare those effects between the four modalities in order to identify those which most effective than the others.
Detailed description
Three Intermittent Pneumatic Compression (IPC) devices were selected: Foot-IPC, rapid Calf-IPC and a slow, sequential Calf-IPC. A Neuromuscular Electrical Stimulation (NMES) device was also used in the calf. Blood flow measurements in the right popliteal vein of ten healthy individuals were performed using Doppler ultrasound before (control) and while using IPC or NMES. The blood flow parameters measured where: peak systolic velocity (cm/s), time-averaged mean velocity (cm/sec), volume flow (ml/min) and ejected volume per individual stimulus (ml). The tolerability of each device was also assessed using an analogue scale from zero to ten. Differences between modalities regarding the pattern as well as the absolute values of velocity and volume are being assessed. Power calculation: Recent studies showed that the peak venous velocity (PV) at baseline is around 11 cm/s and after applying foot-IPC the PV rises to 50 cm/s with a maximum standard deviation of 15 (Broderick et all, 2014). Thus, three patients per group would be required to detect a difference of 39 cm/s in PV (two-sided type-I error rate = 5%; power = 80%). To reach an even higher power we choose to include 10 patients in study, which resulted in a power of 99.7% for the above calculation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Foot IPC | Active comparator | Device: Foot IPCIntermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA |
| Rapid calf IPC | Active comparator | Device: Rapid calf IPCIntermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA |
| Slow calf IPC | Active comparator | Device: Slow calf IPCIntermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA |
| Calf NMES | Active comparator | Device: Calf NMESNeuromuscular electrical stimulation in the calf using the DJO,TM, CefarCompex Mi-Theta 500 stimulator |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers
Key exclusion criteria (5 listed)
- pregnancy
- previous lower limb operation involving the vascular system
- current thromboprophylactic or thrombolytic therapy
- vascular abnormalities in the lower limbs
- cardiorespiratory or renal failure causing pitting oedema
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 |
|---|---|---|
| Foot IPCAlso: Intermittent pneumatic compression in the footIntermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA | Device | Foot IPC |
| Rapid calf IPCAlso: Rapid Intermittent pneumatic compression in the calfIntermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA | Device | Rapid calf IPC |
| Slow calf IPCAlso: Slow Intermittent pneumatic compression in the calfIntermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA | Device | Slow calf IPC |
| Calf NMESAlso: Calf neuromuscular electrical stimulationNeuromuscular electrical stimulation in the calf using the DJOTM, CefarCompex Mi-Theta 500 stimulator | Device | Calf NMES |
Primary outcome
Blood Flow - Peak Systolic Velocity (cm/Sec)
Time frame: up to one hour in total
With the use of Doppler Ultrasound Peak systolic velocity (cm/sec) is assessed in the popliteal vein.
Blood Flow - Time-averaged Mean Velocity (cm/Sec)
Time frame: up to one hour in total
With the use of Doppler Ultrasound Time-averaged mean velocity (cm/sec) is assessed in the popliteal vein.
Blood Flow - Volume Flow (ml/Min)
Time frame: up to one hour in total
With the use of Doppler Ultrasound Volume flow (ml/min), is assessed in the popliteal vein.
Blood Flow - Ejected Volume Per Individual Stimulus (ml)
Time frame: up to one hour in total
With the use of Doppler Ultrasound Ejected volume per individual stimulus (ml) is assessed in the popliteal vein.
1 secondary outcome
Tolerability to IPC and NMES According to Visual Analogue Scale 0-10
Time frame: one minute
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Foot IPC, Rapid calf IPC and Slow calf IPC in people with Venous Stasis and Deep Vein Thrombosis, run by Karolinska University Hospital.
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 5 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 23 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
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 12 Feb 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?
Blood Flow - Peak Systolic Velocity (cm/Sec) (time frame: up to one hour in total). The study lists 4 primary outcomes in all. 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 23 Sep 2020.