Validation of the MoistureMeterD in Local Edema by Histamine

Lymphedema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01833156
• Other study ID #: NS5NL
• Status: Completed
• Phase: N/A
• First received: March 27, 2013
• Last updated: June 9, 2013
• Start date: March 2013
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Nij Smellinghe Hosptial
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lymphedema

Intervention

Device:
• MoistureMeterD
measuring erythema size and the dielectric constant values

Locations

Country	Name	City	State
Netherlands	Expert Center for Lymphovascular Medicine Nij Smellinghe Hospital	Drachten	Friesland

Sponsors (1)

Lead Sponsor	Collaborator
Nij Smellinghe Hosptial

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes

External Links

•   company from the MoistureMeterD
•   The foundation related to the expert centre organizing research