Validation of the MoistureMeterD in Local Edema by Histamine

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01833156

Enrollment

Registered

2013-04-16

Start date

2013-03-31

Completion date

2013-06-30

Last updated

2013-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema

Keywords

local edema, dielectric constant values, validation study

Brief summary

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

Detailed description

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: 1. research the inter- and intra observer variability 2. measure the reproducibility of edema formation in a standardized edema formation

Interventions

DEVICEMoistureMeterD

measuring erythema size and the dielectric constant values

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
amount of edema formation measured with a moisturemeterD of histamin reaction	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

Measure	Time frame	Description
validation of a Moisturemeter device for inter- and intra observer variability	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)

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026