An interventional study of Orthosis VACOped and Below knee cast in Venous Stasis and Deep Venous Thrombosis, sponsored by Karolinska University Hospital. Recruiting at 1 site in Sweden. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by Karolinska University Hospital · Not applicable, Interventional, and Basic science
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.
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.
Exclusion Criteria:
A below knee cast is applied in order to achieve ankle immobilisation for one hour
Device: Below knee cast
A below knee orthosis which allows for ankle movement is applied for one hour.
Device: Orthosis VACOped
Orthosis for lower limb immobilisation
Below knee cast for lower limb immobilisation
Also known as: Plastrer cast of Paris
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)
Time frame: 2.5 hours
Lower limb macrocirculation under cast immobilisation
Duplex ultrasound (blood flow)
Time frame: 1 hour
Lower limb microcirculation under cast immobilisation
INVOS (regional tissue mixed saturation)
Time frame: 1 hour
Lower limb macrocirculation under orthosis mobilisation
Duplex ultrasound (blood flow)
Time frame: 1 hour
Lower limb microcirculation under orthosis mobilisation
INVOS (regional tissue mixed saturation)
Time frame: 1 hour
Plan to share: Yes — Publishing an abstract on Reasearch Gate
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Karolinska University Hospital