Validation of the MoistureMeterD in Local Edema by Histamine

Study Overview
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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

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

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

Conditions
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Lymphedema

Intervention / Treatment
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* Device: MoistureMeterD


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient with local edema by histamin<br>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 | Device: MoistureMeterD<br>* measuring erythema size and the dielectric constant values<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of edema formation measured with a moisturemeterD of histamin reaction | 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. | october 2013 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| validation of a Moisturemeter device for inter- and intra observer variability | 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) | october 2013 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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local edema, dielectric constant values, validation study