A New Intelligent Stocking for Quantification of Edema in the Lower Limbs
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
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
|
Outcome Measures
Primary Outcome Measures
- Leg volume measured with ESD (ml) [1 minute]
Obtained with the Edema Stocking device
- Leg volume measured with WDV (ml) [1 minute]
Obtained with water displacement volumetry
- Leg circumference measured with tape measure (mm) [1 minute]
Obtained with tape measure
- Leg circumference measured with ESD (mm) [60 minutes]
Obtained with the Edema Stocking Device
Eligibility Criteria
Criteria
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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department og Gynaecology and Obstetrics, Aarhus University Hospital | Aarhus | Denmark | 8200 |
Sponsors and Collaborators
- University of Aarhus
- Ohmatex ApS
- Aarhus University Hospital
Investigators
- Study Director: Olav B Petersen, MD, PhD, Aarhus University Hospital
Study Documents (Full-Text)
More Information
Publications
None provided.- 1-10-72-143-17
- 2017084027