An observational study in Edema Leg, sponsored by University of Aarhus. Terminated at 1 site in Denmark. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-06-04.
Sponsored by University of Aarhus · Observational
The purpose of the study is to evaluate a prototype of an intelligent stocking (Edema Stocking Device [ESD]), consisting of two stretch sensitive sensors, as a new method for continuously lower leg volume monitoring. The study is a scientific evaluation of the ESD compared with water displacement volumetry and tape measure.
Background:
Balance of body fluids is strictly regulated within a narrow range and is controlled by water movement between the interstitial compartment and the capillaries. An unnatural balance between the two compartments can be seen in several diseases, leading to a net filtration out of the vascular space, resulting in the formation of edema. Monitoring of edema formation represents a unique way of evaluating the degree of the underlying disease and effect of treatment. Numerous different methods can be used to quantify leg volume. However, no current method provides continuous quantitative assessment. The feasibility of continuous lower leg measuring using an intelligent stocking was hypothesized.
The aim of the study was to evaluate the Edema Stocking device (ESD) as a tool for continuous quantification of edema compared with water displacement volumetry (WDV) and tape measure.
Materials and methods:
Study design: Non-randomized equivalence study. Experimental comparison study of new method compared to golden standard.
825 studies on the registry are indexed under Edema; 91 are open to participants now.
This study's enrollment of 6 is below the median of 71 across 171 observational studies indexed under Edema.
Browse Edema studies →University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women, 20-40 years, located to the Central Region of Denmark, admitted to Department of Gynaecology and Obstetrics, Aarhus University Hospital, Denmark.
Exclusion Criteria:
Pregnant women with clinical lower leg edema measured two times with Edema Stocking device, two times with water displacement volumetry and two with tape measure each day for three days.
Device: Single volume measurement with ESD · Device: Single volume measurement with WDV · Device: Single circumference measurement with tape measure · Device: Continuous volume measurement with ESD
Single volume measurement with Edema Stocking device
Single volume measurement with water displacement volumetry method
Single circumference measurement with tape measure
Continuous volume measurement with Edema Stocking device
Leg volume measured with ESD (ml)
Obtained with the Edema Stocking device
Time frame: 1 minute
Leg volume measured with WDV (ml)
Obtained with water displacement volumetry
Time frame: 1 minute
Leg circumference measured with tape measure (mm)
Obtained with tape measure
Time frame: 1 minute
Leg circumference measured with ESD (mm)
Obtained with the Edema Stocking Device
Time frame: 60 minutes
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Plan to share: Undecided
This study is terminated, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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University of Aarhus