Validation of the MoistureMeterD in Local Edema by Histamine

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-06-30

Brief Summary

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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

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Detailed Description

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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

Conditions

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Lymphedema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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patient with local edema by histamin

Measuring at 3 locations (on the histmin spot, at 5 cm and 10 cm border (is the control) at 7 times: T0 - T10 minutes - T20 - T30 - T45 - T60 - T75

Group Type EXPERIMENTAL

MoistureMeterD

Intervention Type DEVICE

measuring erythema size and the dielectric constant values

Interventions

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MoistureMeterD

measuring erythema size and the dielectric constant values

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes