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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05310435
Enrollment
6
Registered
2022-04-05
Start date
2018-08-01
Completion date
2025-01-30
Last updated
2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edema Leg

Keywords

Lower leg edema, Equivalence study, Leg volume

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.

Interventions

DEVICESingle volume measurement with ESD

Single volume measurement with Edema Stocking device

DEVICESingle volume measurement with WDV

Single volume measurement with water displacement volumetry method

DEVICESingle circumference measurement with tape measure

Single circumference measurement with tape measure

DEVICEContinuous volume measurement with ESD

Continuous volume measurement with Edema Stocking device

Sponsors

Ohmatex ApS
CollaboratorUNKNOWN
Aarhus University Hospital
CollaboratorOTHER
University of Aarhus
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years

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).

Design outcomes

Primary

MeasureTime frameDescription
Leg volume measured with ESD (ml)1 minuteObtained with the Edema Stocking device
Leg volume measured with WDV (ml)1 minuteObtained with water displacement volumetry
Leg circumference measured with tape measure (mm)1 minuteObtained with tape measure
Leg circumference measured with ESD (mm)60 minutesObtained with the Edema Stocking Device

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026