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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05310435
Other study ID # 1-10-72-143-17
Secondary ID 2017084027
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2018
Est. completion date December 30, 2023

Study information

Verified date November 2023
Source University of Aarhus
Contact Alexander E Kaspersen
Phone 004525339198
Email alemka@clin.au.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date December 30, 2023
Est. primary completion date December 30, 2023
Accepts healthy volunteers
Gender Female
Age group 20 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Single volume measurement with ESD
Single volume measurement with Edema Stocking device
Single volume measurement with WDV
Single volume measurement with water displacement volumetry method
Single circumference measurement with tape measure
Single circumference measurement with tape measure
Continuous volume measurement with ESD
Continuous volume measurement with Edema Stocking device

Locations

Country Name City State
Denmark Department og Gynaecology and Obstetrics, Aarhus University Hospital Aarhus

Sponsors (3)

Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital, Ohmatex ApS

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Leg volume measured with ESD (ml) Obtained with the Edema Stocking device 1 minute
Primary Leg volume measured with WDV (ml) Obtained with water displacement volumetry 1 minute
Primary Leg circumference measured with tape measure (mm) Obtained with tape measure 1 minute
Primary Leg circumference measured with ESD (mm) Obtained with the Edema Stocking Device 60 minutes
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