NCT05310435

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 6 (actual)
• Sponsor: University of Aarhus · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: —

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.

Conditions

• Edema Leg

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-08-01
• Primary completion: 2025-01-30
• Completion: 2025-01-30
• First posted: 2022-04-05
• Last updated: 2025-06-04

Locations

1 site across 1 country: Denmark