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NCT03420664 Clinical Trial

Comparison of the Effects of Lower Limb Immobilisation With Cast and Orthosis

Deep Venous Thrombosis Clinical Trial

Official title:
The Effects of Different Types of Ankle Immobilisation in the Micro- and Macrocirculation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03420664
Other study ID # SW2017-02-IMMOB
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 10, 2017
Est. completion date December 24, 2025

Study information
Verified date March 2024
Source Karolinska University Hospital
Contact Paul W Ackermann, MD, PhD
Phone +46851770000
Email paul.ackermann@ki.se
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date December 24, 2025
Est. primary completion date December 24, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Healthy individuals Exclusion Criteria: - Severe cardiovascular or renal disease causing pitting oedema - Previous operation in the lower limbs affecting the vascular or lymphatic system - Pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Orthosis VACOped
Orthosis for lower limb immobilisation
• Below knee cast
Below knee cast for lower limb immobilisation

Locations
Country Name City State
Sweden Karolinska university Hospital Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Karolinska University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) 2.5 hours
Secondary Lower limb macrocirculation under cast immobilisation Duplex ultrasound (blood flow) 1 hour
Secondary Lower limb microcirculation under cast immobilisation INVOS (regional tissue mixed saturation) 1 hour
Secondary Lower limb macrocirculation under orthosis mobilisation Duplex ultrasound (blood flow) 1 hour
Secondary Lower limb microcirculation under orthosis mobilisation INVOS (regional tissue mixed saturation) 1 hour
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