Validation of the MoistureMeterD in Local Edema by Histamine

Not Applicable

Completed

• Conditions: Lymphedema
• Interventions: Device: MoistureMeterD

• Registration Number: NCT01833156
• Lead Sponsor: Nij Smellinghe Hosptial

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

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-27
• Study First Submitted QC: 2013-04-15
• Study First Posted: 2013-04-16
• Status Verified: 2013-06
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Last Update Submitted: 2013-06-09
• Last Update Posted: 2013-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patient with local edema by histamin	MoistureMeterD	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Expert Center for Lymphovascular Medicine Nij Smellinghe Hospital; 🇳🇱 Drachten, Friesland, Netherlands