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

May 30, 2025 updated by: Alexander Emil Kaspersen, University of Aarhus
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Department og Gynaecology and Obstetrics, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Pregnant women, 20-40 years, located to the Central Region of Denmark, admitted to Department of Gynaecology and Obstetrics, Aarhus University Hospital, Denmark.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnant women with lower leg edema
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
Single volume measurement with Edema Stocking device
Device: Single volume measurement with WDV
Single volume measurement with water displacement volumetry method
Device: Single circumference measurement with tape measure
Single circumference measurement with tape measure
Device: Continuous volume measurement with ESD
Continuous volume measurement with Edema Stocking device

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital
Ohmatex ApS

Investigators

  • Study Director: Olav B Petersen, MD, PhD, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2018

Primary Completion (Actual)

January 30, 2025

Study Completion (Actual)

January 30, 2025

Study Registration Dates

First Submitted

March 25, 2022

First Submitted That Met QC Criteria

March 25, 2022

First Posted (Actual)

April 5, 2022

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

May 30, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-143-17
  • 2017084027 (Other Identifier: Danish Medicines Agency)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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