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

University of Aarhus

Status: Terminated

Conditions: Edema Leg

Treatments: Device: Continuous volume measurement with ESD; Device: Single volume measurement with ESD; Device: Single volume measurement with WDV; Device: Single circumference measurement with tape measure

Study type: Observational

Funder types: Other

Identifiers

NCT05310435

1-10-72-143-17

2017084027 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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).

Trial design

6 participants in 1 patient group

Pregnant women with lower leg edema

Description:

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.

Treatment:

Device: Single circumference measurement with tape measure

Device: Single volume measurement with WDV

Device: Single volume measurement with ESD

Device: Continuous volume measurement with ESD