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

NCT03420664 | Recruiting

• 1 other identifier: SW2017-02-IMMOB
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Venous Stasis; Deep Venous Thrombosis

Keywords

cast; orthosis; immobilisation; venous stasis; circulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Lower limb macrocirculation under cast immobilisation

  1 hour

• Lower limb microcirculation under cast immobilisation

  1 hour

• Lower limb macrocirculation under orthosis mobilisation

  1 hour

• Lower limb microcirculation under orthosis mobilisation

  1 hour

Study Arms (2)

Cast immobilisation

EXPERIMENTAL

A below knee cast is applied in order to achieve ankle immobilisation for one hour

Device: Below knee cast

Orthosis (VACOped) immobilisation

EXPERIMENTAL

A below knee orthosis which allows for ankle movement is applied for one hour.

Device: Orthosis VACOped

Interventions

Orthosis VACOped DEVICE

Orthosis for lower limb immobilisation

Orthosis (VACOped) immobilisation

Below knee cast DEVICE

Below knee cast for lower limb immobilisation

Also known as: Plastrer cast of Paris

Cast immobilisation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy individuals

You may not qualify if:

• Severe cardiovascular or renal disease causing pitting oedema
• Previous operation in the lower limbs affecting the vascular or lymphatic system
• Pregnancy

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska university Hospital

Stockholm, 17176, Sweden

RECRUITING

MeSH Terms

Conditions

Varicose Ulcer; Venous Thrombosis

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Thrombosis; Embolism and Thrombosis

Central Study Contacts

Paul W Ackermann, MD, PhD

CONTACT

+46851770000; paul.ackermann@ki.se

Luigi Belcastro

CONTACT

Luigi.belcastro@sll.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Model Details: Research subjects receive lower limb immobilisation with cast and with orthosis alternatively, randomised so as subsequent persons begin with different modality.

Study Record Dates

• First Submitted: February 9, 2017
• First Posted: February 5, 2018
• Study Start: February 10, 2017
• Primary Completion: December 24, 2024
• Study Completion: December 24, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)