Edema LegNCT05310435
A New Intelligent Stocking for Quantification of Edema in the Lower Limbs
An observational study of Edema Leg, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Edema Leg
- What is being tested?
- Single volume measurement with ESD, Single volume measurement with WDV and Single circumference measurement with tape measure
- Type of treatment
- Medical device
- How many people
- 6 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2018to 30 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Adult
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.
Who may be able to join
- Edema of the lower legs.
- Between 20-18 years.
- Identified at Department of Gynaecology and Obstetrics, Aarhus University Hospital, Denmark.
Who cannot join
- Length of lower leg of more than 34,0 cm (measured from floor to knee).
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department og Gynaecology and Obstetrics, Aarhus University Hospital
Aarhus, 8200
About this study
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.
Read the 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
- Being tested
- Single volume measurement with ESD, Single volume measurement with WDV, Single circumference measurement with tape measure, Continuous volume measurement with ESD
- Keywords
- Lower leg edema, Equivalence study, Leg volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single volume measurement with ESDDevice
Single volume measurement with Edema Stocking device
Single volume measurement with WDVDevice
Single volume measurement with water displacement volumetry method
Single circumference measurement with tape measureDevice
Single circumference measurement with tape measure
Continuous volume measurement with ESDDevice
Continuous volume measurement with Edema Stocking device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leg volume measured with ESD (ml)
Obtained with the Edema Stocking device
Measured: 1 minute
Leg volume measured with WDV (ml)
Obtained with water displacement volumetry
Measured: 1 minute
Leg circumference measured with tape measure (mm)
Obtained with tape measure
Measured: 1 minute
Leg circumference measured with ESD (mm)
Obtained with the Edema Stocking Device
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start1 Aug 2018
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Why it stopped: Not enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edema LegStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Ohmatex ApS, Aarhus University Hospital
- Responsible party
- Principal investigator, Alexander Emil Kaspersen, University of Aarhus
- Investigators
- Olav B Petersen, MD, PhD, Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310435
- Sponsor's protocol ID
- 1-10-72-143-17
- Other IDs
- 2017084027
- Status last verified
- May 2025
- First submitted
- 25 Mar 2022
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Intelligent Stocking for Quantification of Edema in the Lower Limbs
- ClinicalTrials.gov ID
- NCT05310435
- Acronym / sponsor ID
- 1-10-72-143-17
- Conditions
- Edema Leg
- Keywords
- Lower leg edema, Equivalence study, Leg volume
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not enough patients
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Ohmatex ApS, Aarhus University Hospital
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with lower leg edema | – | Device: Single volume measurement with ESD, Device: Single volume measurement with WDV, Device: Single circumference measurement with tape measure, Device: Continuous volume measurement with ESDPregnant 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- Edema of the lower legs.
- Between 20-18 years.
- Identified at Department of Gynaecology and Obstetrics, Aarhus University Hospital, Denmark.
Key exclusion criteria (1 listed)
- Length of lower leg of more than 34,0 cm (measured from floor to knee).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single volume measurement with ESDSingle volume measurement with Edema Stocking device | Device | Pregnant women with lower leg edema |
| Single volume measurement with WDVSingle volume measurement with water displacement volumetry method | Device | Pregnant women with lower leg edema |
| Single circumference measurement with tape measureSingle circumference measurement with tape measure | Device | Pregnant women with lower leg edema |
| Continuous volume measurement with ESDContinuous volume measurement with Edema Stocking device | Device | Pregnant women with lower leg edema |
Primary outcome
Leg volume measured with ESD (ml)
Time frame: 1 minute
Obtained with the Edema Stocking device
Leg volume measured with WDV (ml)
Time frame: 1 minute
Obtained with water displacement volumetry
Leg circumference measured with tape measure (mm)
Time frame: 1 minute
Obtained with tape measure
Leg circumference measured with ESD (mm)
Time frame: 60 minutes
Obtained with the Edema Stocking Device
Results and safety
The study was stopped early (reason given: Not enough patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olav B Petersen, MD, PhD study director
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Edema Leg, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not enough patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leg volume measured with ESD (ml) (time frame: 1 minute). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2025.