A New Intelligent Stocking for Quantification of Edema in the Lower Limbs
NCT ID: NCT05310435
Last Updated: 2025-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
6 participants
OBSERVATIONAL
2018-08-01
2025-01-30
Brief Summary
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Detailed Description
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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
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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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.
Single volume measurement with ESD
Single volume measurement with Edema Stocking device
Single volume measurement with WDV
Single volume measurement with water displacement volumetry method
Single circumference measurement with tape measure
Single circumference measurement with tape measure
Continuous volume measurement with ESD
Continuous volume measurement with Edema Stocking device
Interventions
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Single volume measurement with ESD
Single volume measurement with Edema Stocking device
Single volume measurement with WDV
Single volume measurement with water displacement volumetry method
Single circumference measurement with tape measure
Single circumference measurement with tape measure
Continuous volume measurement with ESD
Continuous volume measurement with Edema Stocking device
Eligibility Criteria
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Inclusion Criteria
* Between 20-18 years.
* Identified at Department of Gynaecology and Obstetrics, Aarhus University Hospital, Denmark.
Exclusion Criteria
20 Years
40 Years
FEMALE
No
Sponsors
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Ohmatex ApS
UNKNOWN
Aarhus University Hospital
OTHER
University of Aarhus
OTHER
Responsible Party
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Alexander Emil Kaspersen
Project manager
Principal Investigators
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Olav B Petersen, MD, PhD
Role: STUDY_DIRECTOR
Aarhus University Hospital
Locations
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Department og Gynaecology and Obstetrics, Aarhus University Hospital
Aarhus, , Denmark
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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2017084027
Identifier Type: OTHER
Identifier Source: secondary_id
1-10-72-143-17
Identifier Type: -
Identifier Source: org_study_id
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