A New Intelligent Stocking for Quantification of Edema in the Lower Limbs

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A New Intelligent Stocking for Quantification of Edema in the Lower Limbs

Conditions
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Edema Leg

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women with lower leg edema<br>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<br>* Single volume measurement with Edema Stocking device<br>Device: Single volume measurement with WDV<br>* Single volume measurement with water displacement volumetry method<br>Device: Single circumference measurement with tape measure<br>* Single circumference measurement with tape measure<br>Device: Continuous volume measurement with ESD<br>* Continuous volume measurement with Edema Stocking device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leg volume measured with ESD (ml) | Obtained with the Edema Stocking device | 1 minute | 
| Leg volume measured with WDV (ml) | Obtained with water displacement volumetry | 1 minute | 
| Leg circumference measured with tape measure (mm) | Obtained with tape measure | 1 minute | 
| Leg circumference measured with ESD (mm) | Obtained with the Edema Stocking Device | 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lower leg edema, Equivalence study, Leg volume