Venous StasisNCT03420664
Comparison of the Effects of Lower Limb Immobilisation With Cast and Orthosis
A study testing Orthosis VACOped and Below knee cast in people with Venous Stasis and Deep Venous Thrombosis, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
In this study we are going to measure the blood flow in the lower limbs under cast immobilisation and also under mobilisation with an orthosis. The aim is to evaluate how the aforementioned modalities affect the blood flow and also to compare between the two. 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 Venous Thrombosis
- What is being tested?
- Orthosis VACOped and Below knee cast
- 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
- 10 Feb 2017to 24 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals
Who cannot join
- Severe cardiovascular or renal disease causing pitting oedema
- Previous operation in the lower limbs affecting the vascular or lymphatic system
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Luigi Belcastro contact
Sweden1 site, 1 recruiting
- Recruiting
Karolinska university Hospital
Stockholm, 17176
Luigi Belcastro, +46851775678, luigi.belcastro@karolinska.se
About this study
Official title: The Effects of Different Types of Ankle Immobilisation in the Micro- and Macrocirculation
In this study we are going to measure the blood flow in the lower limbs under cast immobilisation and also under mobilisation with an orthosis. The aim is to evaluate how the aforementioned modalities affect the blood flow and also to compare between the two.
Read the detailed description
Background: Lower limb immobilisation, for example after an Achilles tendon rupture, is known to be a cause for DVT, partly due to blood stasis. VACOped is a weight-bearing orthosis with adjustable range of motion of the ankle which is used in our department in patients operated for Achilles tendon rupture.
Aim: To assess the effects of a) lower leg casting in equinus without loading and b) application of the aforementioned orthosis with full weight baring in blood flow and microcirculation in the lower limbs.
Study Plan: Ten healthy individuals are planned to be recruited for this study. Blood flow in the Right popliteal will be measured with vein before, 30 and 60 min after the application of the cast or orthosis (alternate order between consequent individuals) with Duplex Ultrasound. The orthosis will be set to allow for ankle plantarflexion restricted between 15 and 30 degrees. Tissue oxygen saturation in the lower limbs will also be measured using a somatic regional oxymetry modality, INVOS, with adhesive sensors applied on each leg above the soleus.
- Conditions
- Venous Stasis, Deep Venous Thrombosis
- Being tested
- Orthosis VACOped, Below knee cast
- Keywords
- cast, orthosis, immobilisation, venous stasis, circulation
- 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.
Orthosis VACOpedDevice
Orthosis for lower limb immobilisation
Below knee castDevice
Also called Plastrer cast of Paris
Below knee cast for lower limb immobilisation
| Study group | Role | What they receive |
|---|---|---|
| Cast immobilisation | Experimental | A below knee cast is applied in order to achieve ankle immobilisation for one hour Receives: Device: Below knee cast |
| Orthosis (VACOped) immobilisation | Experimental | A below knee orthosis which allows for ankle movement is applied for one hour. Receives: Device: Orthosis VACOped |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference of the effect on the lower limb circulation between cast and VACOped immobilisation
Duplex ultrasound (blood flow) and INVOS (regional tissue mixed saturation)
Measured: 2.5 hours
Secondary outcomes (4)
Lower limb macrocirculation under cast immobilisation
Duplex ultrasound (blood flow)
Measured: 1 hour
Lower limb microcirculation under cast immobilisation
INVOS (regional tissue mixed saturation)
Measured: 1 hour
Lower limb macrocirculation under orthosis mobilisation
Duplex ultrasound (blood flow)
Measured: 1 hour
Lower limb microcirculation under orthosis mobilisation
INVOS (regional tissue mixed saturation)
Measured: 1 hour
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 start10 Feb 2017
- Primary completion24 Dec 2024 (estimated)
- Study completion24 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
- Research subjects receive lower limb immobilisation with cast and with orthosis alternatively, randomised so as subsequent persons begin with different modality.
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420664
- Sponsor's protocol ID
- SW2017-02-IMMOB
- 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
- Individual data sharing
- Yes: Publishing an abstract on Reasearch Gate
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
- The Effects of Different Types of Ankle Immobilisation in the Micro- and Macrocirculation
- ClinicalTrials.gov ID
- NCT03420664
- Acronym / sponsor ID
- SW2017-02-IMMOB
- Conditions
- Venous Stasis, Deep Venous Thrombosis
- Keywords
- cast, orthosis, immobilisation, venous stasis, circulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- 10 Feb 2017 (actual)
- Primary completion
- 24 Dec 2024 (estimated)
- Study completion
- 24 Dec 2025 (estimated)
- First posted
- 5 Feb 2018 (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.
In this study we are going to measure the blood flow in the lower limbs under cast immobilisation and also under mobilisation with an orthosis. The aim is to evaluate how the aforementioned modalities affect the blood flow and also to compare between the two.
Detailed description
Background: Lower limb immobilisation, for example after an Achilles tendon rupture, is known to be a cause for DVT, partly due to blood stasis. VACOped is a weight-bearing orthosis with adjustable range of motion of the ankle which is used in our department in patients operated for Achilles tendon rupture.
Aim: To assess the effects of a) lower leg casting in equinus without loading and b) application of the aforementioned orthosis with full weight baring in blood flow and microcirculation in the lower limbs.
Study Plan: Ten healthy individuals are planned to be recruited for this study. Blood flow in the Right popliteal will be measured with vein before, 30 and 60 min after the application of the cast or orthosis (alternate order between consequent individuals) with Duplex Ultrasound. The orthosis will be set to allow for ankle plantarflexion restricted between 15 and 30 degrees. Tissue oxygen saturation in the lower limbs will also be measured using a somatic regional oxymetry modality, INVOS, with adhesive sensors applied on each leg above the soleus.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Research subjects receive lower limb immobilisation with cast and with orthosis alternatively, randomised so as subsequent persons begin with different modality.
| Arm | Type | Receives |
|---|---|---|
| Cast immobilisation | Experimental | Device: Below knee castA below knee cast is applied in order to achieve ankle immobilisation for one hour |
| Orthosis (VACOped) immobilisation | Experimental | Device: Orthosis VACOpedA below knee orthosis which allows for ankle movement is applied for one hour. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy individuals
Key exclusion criteria (3 listed)
- Severe cardiovascular or renal disease causing pitting oedema
- Previous operation in the lower limbs affecting the vascular or lymphatic system
- Pregnancy
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 |
|---|---|---|
| Orthosis VACOpedOrthosis for lower limb immobilisation | Device | Orthosis (VACOped) immobilisation |
| Below knee castAlso: Plastrer cast of ParisBelow knee cast for lower limb immobilisation | Device | Cast immobilisation |
Primary outcome
The difference of the effect on the lower limb circulation between cast and VACOped immobilisation
Time frame: 2.5 hours
Duplex ultrasound (blood flow) and INVOS (regional tissue mixed saturation)
4 secondary outcomes
Lower limb macrocirculation under cast immobilisation
Time frame: 1 hour
Lower limb microcirculation under cast immobilisation
Time frame: 1 hour
Lower limb macrocirculation under orthosis mobilisation
Time frame: 1 hour
Lower limb microcirculation under orthosis mobilisation
Time frame: 1 hour
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.
- Individual participant dataSharing planned: Yes. Publishing an abstract on Reasearch Gate
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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.
Luigi Belcastro contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthosis VACOped and Below knee cast 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 1 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?
Contact Paul W Ackermann, MD, PhD (+46851770000, paul.ackermann@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference of the effect on the lower limb circulation between cast and VACOped immobilisation (time frame: 2.5 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.