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

NCT05310435 | Terminated DMC

• 2 other identifiers: 1-10-72-143-172017084027
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Edema Leg

Keywords

Lower leg edema; Equivalence study; Leg volume

Outcome Measures

Primary Outcomes (4)

• Leg volume measured with ESD (ml)

  Obtained with the Edema Stocking device

  1 minute

• Leg volume measured with WDV (ml)

  Obtained with water displacement volumetry

  1 minute

• Leg circumference measured with tape measure (mm)

  Obtained with tape measure

  1 minute

• Leg circumference measured with ESD (mm)

  Obtained with the Edema Stocking Device

  60 minutes

Study Arms (1)

Pregnant women with lower leg edema

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.

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

Interventions

Single volume measurement with ESD DEVICE

Single volume measurement with Edema Stocking device

Pregnant women with lower leg edema

Single volume measurement with WDV DEVICE

Single volume measurement with water displacement volumetry method

Pregnant women with lower leg edema

Single circumference measurement with tape measure DEVICE

Single circumference measurement with tape measure

Pregnant women with lower leg edema

Continuous volume measurement with ESD DEVICE

Continuous volume measurement with Edema Stocking device

Pregnant women with lower leg edema

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Pregnant women
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women, 20-40 years, located to the Central Region of Denmark, admitted to Department of Gynaecology and Obstetrics, Aarhus University Hospital, Denmark.

You may qualify if:

• Edema of the lower legs.
• Between 20-18 years.
• Identified at Department of Gynaecology and Obstetrics, Aarhus University Hospital, Denmark.

You may not qualify if:

• Length of lower leg of more than 34,0 cm (measured from floor to knee).

Sponsors & Collaborators

• University of Aarhus: lead
• Ohmatex ApS: collaborator
• Aarhus University Hospital: collaborator

Study Sites (1)

Department og Gynaecology and Obstetrics, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Study Officials

• Olav B Petersen, MD, PhD

  Aarhus University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project manager

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 5, 2022
• Study Start: August 1, 2018
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

DK (1)