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

Edema Leg Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05310435
• Other study ID #: 1-10-72-143-17
• Secondary ID: 2017084027
• Status: Recruiting
• 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
• 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
• 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).

Related Conditions & MeSH terms

• Edema
• Edema Leg

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