Validation of the MoistureMeterD in Local Edema by Histamine
Primary Purpose
Lymphedema
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
MoistureMeterD
Sponsored by
About this trial
This is an interventional diagnostic trial for Lymphedema focused on measuring local edema, dielectric constant values, validation study
Eligibility Criteria
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
Sites / Locations
- Expert Center for Lymphovascular Medicine Nij Smellinghe Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patient with local edema by histamin
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01833156
Brief Title
Validation of the MoistureMeterD in Local Edema by Histamine
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.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nij Smellinghe Hosptial
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
research the inter- and intra observer variability
measure the reproducibility of edema formation in a standardized edema formation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema
Keywords
local edema, dielectric constant values, validation study
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patient with local edema by histamin
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
MoistureMeterD
Intervention Description
measuring erythema size and the dielectric constant values
Primary Outcome Measure Information:
Title
amount of edema formation measured with a moisturemeterD of histamin reaction
Description
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.
Time Frame
october 2013
Secondary Outcome Measure Information:
Title
validation of a Moisturemeter device for inter- and intra observer variability
Description
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)
Time Frame
october 2013
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J Damstra, MD PhD
Organizational Affiliation
Nij Smellinghe Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Expert Center for Lymphovascular Medicine Nij Smellinghe Hospital
City
Drachten
State/Province
Friesland
ZIP/Postal Code
9202 NN
Country
Netherlands
12. IPD Sharing Statement
Links:
URL
http://www.nijsmellinghe.nl
Description
General website from the Nij Smellinghe hospital
URL
http://www.slcn.nl
Description
The foundation related to the expert centre organizing research
Learn more about this trial
Validation of the MoistureMeterD in Local Edema by Histamine
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