Skip to main content
OpenTrials
Completed

NCT Number: NCT01833156

Validation of the MoistureMeterD in Local Edema by Histamine

In lymphedema there is increase in water content of the tissue. We studied a device (MoistureMeterD) which is suitable to detect water contact in the tissue. Although the apparatus is commercially available, no validation study had been performed in vivo with local edema.

We designed a validation study for inter- and intra observer variability and the reproducibility in vivo by histamin induced local edema

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lymphedema Hemic and Lymphatic Diseases Lymphatic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Expert Center for Lymphovascular Medicine Nij Smellinghe Hospital

Drachten, Provincie Friesland, 9202 NN, Netherlands

About this study

The multiprobe Delfin MoistureMeterD is a unique and compact water-specific instrument for the measurement of water content of biological tissues. It measures the dielectric constant values of the skin and subcutaneous tissues non-invasively and locally in a few seconds. The dielectric constant value is directly proportional to the amount of water in the tissue.

As lymphedema produces local water content increase, we are interested if the device is suitable for daily use in lymphedema patients. Therefore we designed a protocol to measure the results with a moisturemeter in a standardized edema formation by histamin induced scratch test edema. This method is well known in type I allergy testing.

The aim of the study is:

  • research the inter- and intra observer variability
  • measure the reproducibility of edema formation in a standardized edema formation

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 18 years or older;
  • Coming for intra-cutaneous allergy scratch test;
  • Gender: male and female.

Exclusion criteria

  • Patients who have a pacemaker or other inbuilt stimulator;
  • Lymphoedema;
  • Patients who have an infection;
  • Patients with skin problems in research area.
  • No use of anti-histamines medication

Treatment and study plan

MoistureMeterD

Device

measuring erythema size and the dielectric constant values

Primary outcomes

  1. amount of edema formation measured with a moisturemeterD of histamin reaction

    Time frame: october 2013

    At various moments and regions around the scratch location the dielectric constant values of the skin is measured in all patients. we try to see if there is a reproducibility of edema with a standardized edema formation method.

Secondary outcomes

  1. validation of a Moisturemeter device for inter- and intra observer variability

    Time frame: october 2013

    The researchers are randomized in investigator A and B. In several patients at one time three measures are made: A1 and A2 and B. By collecting these data we can calculate the intra-observer variability (A1 versus A2) and the inter observer variability (A1/2 versus B)

Sponsors and collaborators

Lead sponsor

Nij Smellinghe Hosptial

Other

Registry information

Official study title

A Clinimetric Research to Test the Validity of the MoistureMeterD, Conducted by the Local Edema (Urticaria Acuta) Into the Administering of Intradermal Histamine.

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 16, 2013
Registry last updated
Jun 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.