Venous StasisNCT03050671
Effects of External Leg Compression Devices on Healing and Blood Clotting
A study testing Intermittent Pneumatic Compression, Rapid and Intermittent Pneumatic Compression, Slow in people with Venous Stasis and Deep Venous Thrombosis, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
This study aims to compare two different external calf compression devices applied in healthy individuals. These devices are commonly used in medical care in order to prevent the formation of blood clots, for example during immobilization after surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Venous Stasis, Deep Venous Thrombosis, Healing Wound
- What is being tested?
- Intermittent Pneumatic Compression, Rapid and Intermittent Pneumatic Compression, Slow
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSweden
- Study dates
- 18 Jan 2017to 1 Dec 2025
- 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 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals
- Male gender
- Age 18-60
Who cannot join
- Smoking
- Severe cardiovascular or renal disease causing pitting oedema
- Previous operation in the lower limbs affecting the vascular or lymphatic system
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intermittent Pneumatic Compression in the Lower Limbs: Systemic and Local Effects in Coagulation Status, Microcirculation, Tissue Metabolic Activity and Collagen Production.
This study aims to compare two different external calf compression devices applied in healthy individuals. These devices are commonly used in medical care in order to prevent the formation of blood clots, for example during immobilization after surgery. We aim to confirm the effects of external cyclic compression on healing and blood clotting and also to identify the one which is more effective.
Read the detailed description
Aims:
- To confirm that IPC (intermittent pneumatic compression) has a positive effect on systemic coagulation status, tissue metabolic activity, collagen formation and tissue microcirculation.
- To compare the above effect of two different IPC devices: one rapid calf-IPC which expels blood from the veins sharp and rapidly and one slow calf-IPC, which pumps the blood in a more gentle and progressive way. This study could also make implications on how the blood flow parameters could be interpreted in the clinical setting, as previous haemodynamic studies have explained the superiority of the rapid device in terms of peak velocity and the superiority of the slow device in terms of total ejected volume per individual stimulus.
Materials and Methods: 10-15 healthy individuals are planned to be recruited. The subjects will be lying in a prone position. A cuff connected with a Calf-IPC device will be wrapped around each calf and will be functioning for 120 minutes. Microdialysis catheters will be inserted with the tips about 1 mm from the volar side of each Achilles tendon. In addition, one adhesive sensor will be applied on each calf just distal to the lower part of the cuff, in order to measure tissue oxygen mixed saturation (INVOS). Blood samples will be taken via a venous catheter in antecubital fossa just before the application of the IPC, and at 30, 60 and 120 minutes. From the serum, several systemic coagulation factors will be measured (tissue plasminogen activator (tPA), plasminogen activator inhibitor type 1 (PAI), tissue factor pathway inhibitor (TFPI), D-dimer, von Willebrand factor and factor VIIa). From the microdialysis diffusate , two groups of substances will be measured: a) metabolites, such as pyruvate and b) collagen macromolecules, such as procollagen type I and III.
The ultimate goal is to assess the role of different IPC patterns on deep venous thrombosis prevention and promotion of tissue healing.
- Conditions
- Venous Stasis, Deep Venous Thrombosis, Healing Wound
- Being tested
- Intermittent Pneumatic Compression, Rapid, Intermittent Pneumatic Compression, Slow
- 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.
Intermittent Pneumatic Compression, RapidDevice
Cyclic external compression in both calves through a cuff connected to a device which pumps venous blood in a sharp and rapid way
Intermittent Pneumatic Compression, SlowDevice
Cyclic external compression in both calves through a cuff connected to a device which pumps venous blood in a smooth, slow and progressive way
| Study group | Role | What they receive |
|---|---|---|
| Rapid calf-IPC | Active comparator | Cyclic external compression in both calves through a cuff connected to VenaFlow® Elite System, DJO, CA, USA Receives: Device: Intermittent Pneumatic Compression, Rapid |
| subjects under slow calf-IPC | Active comparator | Cyclic external compression in both calves through a cuff connected to Kendall SCD™ 700, Covidien, Medtronic, USA Receives: Device: Intermittent Pneumatic Compression, Slow |
What is being measured
The primary outcome is the main question the study is designed to answer.
systemic coagulation status
serum levels of coagulation factors (vWF, tPA, PAI-1, Factor VIIa, TFPI, D-dimer)
Measured: 2 hours
Secondary outcomes (3)
local metabolic activity
Measurement of tissue metabolic products (eg pyruvate) from diffusate extracted with microdialysis in the Achilles paratenon.
Measured: 2 hours
collagen production
Measurement of collagen from diffusate obtained with microdialysis in the Achilles paratenon.
Measured: 2 hours
regional microcirculation
Mixed oxygen tissue saturation is continuously measured in the lower leg with infrared spectroscopy
Measured: 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2017
- Study start18 Jan 2017
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- There are two different intervension devices planned to be used in each research subject.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Ackermann, Karolinska University Hospital
- Investigators
- Paul Ackermann, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050671
- Sponsor's protocol ID
- SW2017-01-COAGMET
- Status last verified
- Mar 2024
- First submitted
- 9 Feb 2017
- Last updated
- 6 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Pneumatic Compression in the Lower Limbs: Systemic and Local Effects in Coagulation Status, Microcirculation, Tissue Metabolic Activity and Collagen Production.
- ClinicalTrials.gov ID
- NCT03050671
- Acronym / sponsor ID
- SW2017-01-COAGMET
- Conditions
- Venous Stasis, Deep Venous Thrombosis, Healing Wound
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 18 Jan 2017 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 13 Feb 2017 (actual)
- 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 aims to compare two different external calf compression devices applied in healthy individuals. These devices are commonly used in medical care in order to prevent the formation of blood clots, for example during immobilization after surgery. We aim to confirm the effects of external cyclic compression on healing and blood clotting and also to identify the one which is more effective.
Detailed description
Aims:
- To confirm that IPC (intermittent pneumatic compression) has a positive effect on systemic coagulation status, tissue metabolic activity, collagen formation and tissue microcirculation.
- To compare the above effect of two different IPC devices: one rapid calf-IPC which expels blood from the veins sharp and rapidly and one slow calf-IPC, which pumps the blood in a more gentle and progressive way. This study could also make implications on how the blood flow parameters could be interpreted in the clinical setting, as previous haemodynamic studies have explained the superiority of the rapid device in terms of peak velocity and the superiority of the slow device in terms of total ejected volume per individual stimulus.
Materials and Methods: 10-15 healthy individuals are planned to be recruited. The subjects will be lying in a prone position. A cuff connected with a Calf-IPC device will be wrapped around each calf and will be functioning for 120 minutes. Microdialysis catheters will be inserted with the tips about 1 mm from the volar side of each Achilles tendon. In addition, one adhesive sensor will be applied on each calf just distal to the lower part of the cuff, in order to measure tissue oxygen mixed saturation (INVOS). Blood samples will be taken via a venous catheter in antecubital fossa just before the application of the IPC, and at 30, 60 and 120 minutes. From the serum, several systemic coagulation factors will be measured (tissue plasminogen activator (tPA), plasminogen activator inhibitor type 1 (PAI), tissue factor pathway inhibitor (TFPI), D-dimer, von Willebrand factor and factor VIIa). From the microdialysis diffusate , two groups of substances will be measured: a) metabolites, such as pyruvate and b) collagen macromolecules, such as procollagen type I and III.
The ultimate goal is to assess the role of different IPC patterns on deep venous thrombosis prevention and promotion of tissue healing.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are two different intervension devices planned to be used in each research subject.
| Arm | Type | Receives |
|---|---|---|
| Rapid calf-IPC | Active comparator | Device: Intermittent Pneumatic Compression, RapidCyclic external compression in both calves through a cuff connected to VenaFlow® Elite System, DJO, CA, USA |
| subjects under slow calf-IPC | Active comparator | Device: Intermittent Pneumatic Compression, SlowCyclic external compression in both calves through a cuff connected to Kendall SCD™ 700, Covidien, Medtronic, USA |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy individuals
- Male gender
- Age 18-60
Key exclusion criteria (3 listed)
- Smoking
- Severe cardiovascular or renal disease causing pitting oedema
- Previous operation in the lower limbs affecting the vascular or lymphatic system
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 |
|---|---|---|
| Intermittent Pneumatic Compression, RapidCyclic external compression in both calves through a cuff connected to a device which pumps venous blood in a sharp and rapid way | Device | Rapid calf-IPC |
| Intermittent Pneumatic Compression, SlowCyclic external compression in both calves through a cuff connected to a device which pumps venous blood in a smooth, slow and progressive way | Device | subjects under slow calf-IPC |
Primary outcome
systemic coagulation status
Time frame: 2 hours
serum levels of coagulation factors (vWF, tPA, PAI-1, Factor VIIa, TFPI, D-dimer)
3 secondary outcomes
local metabolic activity
Time frame: 2 hours
collagen production
Time frame: 2 hours
regional microcirculation
Time frame: 2.5 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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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.
Paul Ackermann principal investigator
Karolinska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Pneumatic Compression, Rapid and Intermittent Pneumatic Compression, Slow in people with Venous Stasis and Deep Venous Thrombosis, run by Karolinska University Hospital at 1 site in Sweden.
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: status not confirmed, as of the sponsor's last update on 6 Mar 2024. 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 Sweden. 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?
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?
systemic coagulation status (time frame: 2 hours). 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 Mar 2024.