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

Recruiting

• Conditions: Edema Leg
• Interventions: 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

• Registration Number: NCT05310435
• Lead Sponsor: University of Aarhus

Brief 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.

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 Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2022-03-25
• Study First Submitted QC: 2022-03-25
• Study First Posted: 2022-04-05
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-11
• Last Update Posted: 2023-11-14
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 20

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pregnant women with lower leg edema	Single volume measurement with WDV	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.
Pregnant women with lower leg edema	Single circumference measurement with tape measure	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.
Pregnant women with lower leg edema	Continuous volume measurement with ESD	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.
Pregnant women with lower leg edema	Single volume measurement with ESD	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.

Primary Outcome Measures

Name	Time	Method
Leg circumference measured with ESD (mm)	60 minutes	Obtained with the Edema Stocking Device
Leg volume measured with ESD (ml)	1 minute	Obtained with the Edema Stocking device
Leg volume measured with WDV (ml)	1 minute	Obtained with water displacement volumetry
Leg circumference measured with tape measure (mm)	1 minute	Obtained with tape measure

Trial Locations

Locations (1)

Department og Gynaecology and Obstetrics, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark