Comparison of the Effects of Lower Limb Immobilisation With Cast and Orthosis
Primary Purpose
Venous Stasis, Deep Venous Thrombosis
Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Orthosis VACOped
Below knee cast
Sponsored by
About this trial
This is an interventional basic science trial for Venous Stasis focused on measuring cast, orthosis, immobilisation, venous stasis, circulation
Eligibility Criteria
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
Sites / Locations
- Karolinska university HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cast immobilisation
Orthosis (VACOped) immobilisation
Arm Description
A below knee cast is applied in order to achieve ankle immobilisation for one hour
A below knee orthosis which allows for ankle movement is applied for one hour.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Lower limb macrocirculation under cast immobilisation
Duplex ultrasound (blood flow)
Lower limb microcirculation under cast immobilisation
INVOS (regional tissue mixed saturation)
Lower limb macrocirculation under orthosis mobilisation
Duplex ultrasound (blood flow)
Lower limb microcirculation under orthosis mobilisation
INVOS (regional tissue mixed saturation)
Full Information
NCT ID
NCT03420664
First Posted
February 9, 2017
Last Updated
January 3, 2023
Sponsor
Karolinska University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03420664
Brief Title
Comparison of the Effects of Lower Limb Immobilisation With Cast and Orthosis
Official Title
The Effects of Different Types of Ankle Immobilisation in the Micro- and Macrocirculation
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2017 (Actual)
Primary Completion Date
December 24, 2023 (Anticipated)
Study Completion Date
December 24, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Stasis, Deep Venous Thrombosis
Keywords
cast, orthosis, immobilisation, venous stasis, circulation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cast immobilisation
Arm Type
Experimental
Arm Description
A below knee cast is applied in order to achieve ankle immobilisation for one hour
Arm Title
Orthosis (VACOped) immobilisation
Arm Type
Experimental
Arm Description
A below knee orthosis which allows for ankle movement is applied for one hour.
Intervention Type
Device
Intervention Name(s)
Orthosis VACOped
Intervention Description
Orthosis for lower limb immobilisation
Intervention Type
Device
Intervention Name(s)
Below knee cast
Other Intervention Name(s)
Plastrer cast of Paris
Intervention Description
Below knee cast for lower limb immobilisation
Primary Outcome Measure Information:
Title
The difference of the effect on the lower limb circulation between cast and VACOped immobilisation
Description
Duplex ultrasound (blood flow) and INVOS (regional tissue mixed saturation)
Time Frame
2.5 hours
Secondary Outcome Measure Information:
Title
Lower limb macrocirculation under cast immobilisation
Description
Duplex ultrasound (blood flow)
Time Frame
1 hour
Title
Lower limb microcirculation under cast immobilisation
Description
INVOS (regional tissue mixed saturation)
Time Frame
1 hour
Title
Lower limb macrocirculation under orthosis mobilisation
Description
Duplex ultrasound (blood flow)
Time Frame
1 hour
Title
Lower limb microcirculation under orthosis mobilisation
Description
INVOS (regional tissue mixed saturation)
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul W Ackermann, MD, PhD
Phone
+46851770000
Email
paul.ackermann@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Luigi Belcastro
Email
Luigi.belcastro@sll.se
Facility Information:
Facility Name
Karolinska university Hospital
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luigi Belcastro
Phone
+46851775678
Email
luigi.belcastro@karolinska.se
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Publishing an abstract on Reasearch Gate
Learn more about this trial
Comparison of the Effects of Lower Limb Immobilisation With Cast and Orthosis
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