Comparing blood flow effects of a cast versus an orthosis on lower limbs
The Effects of Different Types of Ankle Immobilisation in the Micro- and Macrocirculation
NA · Karolinska University Hospital · NCT03420664
This study is testing how wearing a cast or an orthosis affects blood flow in the lower legs of healthy people.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Karolinska University Hospital (other) |
| Locations | 1 site (Stockholm) |
| Trial ID | NCT03420664 on ClinicalTrials.gov |
What this trial studies
This study evaluates how lower limb immobilization affects blood flow by comparing the use of a cast and an orthosis in healthy individuals. Participants will undergo blood flow measurements in the right popliteal vein before and after the application of either a cast or an orthosis, using Duplex Ultrasound. The study aims to determine the impact of immobilization methods on microcirculation and tissue oxygen saturation in the lower limbs. The orthosis used allows for controlled ankle movement while bearing weight, providing a unique approach to assessing circulation.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy individuals without any significant cardiovascular or renal issues.
Not a fit: Patients with severe cardiovascular or renal diseases, previous lower limb surgeries affecting vascular or lymphatic systems, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for preventing venous stasis and deep venous thrombosis in patients requiring lower limb immobilization.
How similar studies have performed: While there have been studies on immobilization and blood flow, this specific comparison of cast versus orthosis in a controlled setting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stockholm
- Karolinska university Hospital — Stockholm, Sweden (RECRUITING)
Study contacts
- Study coordinator: Paul W Ackermann, MD, PhD
- Email: paul.ackermann@ki.se
- Phone: +46851770000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Venous Stasis, Deep Venous Thrombosis, cast, orthosis, immobilisation, venous stasis, circulation