New intelligent stocking for measuring leg swelling
A New Intelligent Stocking for Quantification of Edema in the Lower Limbs
This study is testing a new smart stocking that measures leg swelling in people with edema to see if it works as well as traditional methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT05310435 on ClinicalTrials.gov |
What this trial studies
This study evaluates a prototype intelligent stocking designed to continuously monitor lower leg volume in patients with edema. The Edema Stocking Device (ESD) uses stretch-sensitive sensors to provide real-time measurements, which will be compared to traditional methods like water displacement volumetry and tape measurement. The goal is to assess the feasibility and accuracy of this new method in quantifying leg swelling, which is important for managing various medical conditions. The study is observational and non-randomized, focusing on the equivalence of the ESD to established measurement techniques.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 20 to 80 with edema in the lower legs.
Not a fit: Patients with lower leg lengths exceeding 34 cm will not benefit from this study.
Why it matters
Potential benefit: If successful, this device could provide a more effective way to monitor edema, leading to better management of underlying health conditions.
How similar studies have performed: While continuous monitoring of edema is a novel approach, similar studies have shown promise in using technology for health monitoring.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Edema of the lower legs. * Between 20-18 years. * Identified at Department of Gynaecology and Obstetrics, Aarhus University Hospital, Denmark. Exclusion Criteria: * Length of lower leg of more than 34,0 cm (measured from floor to knee).
Where this trial is running
Aarhus
- Department og Gynaecology and Obstetrics, Aarhus University Hospital — Aarhus, Denmark (Recruiting)
Study contacts
- Study coordinator: Alexander E Kaspersen
- Email: alemka@clin.au.dk
- Phone: 004525339198
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.