Validation of the MoistureMeterD in Local Edema by Histamine
A Clinimetric Research to Test the Validity of the MoistureMeterD, Conducted by the Local Edema (Urticaria Acuta) Into the Administering of Intradermal Histamine.
1 other identifier
interventional
25
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 27, 2013
CompletedFirst Posted
Study publicly available on registry
April 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJune 11, 2013
June 1, 2013
3 months
March 27, 2013
June 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
validation of a Moisturemeter device for inter- and intra observer variability
october 2013
Study Arms (1)
patient with local edema by histamin
EXPERIMENTALMeasuring 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
Interventions
measuring erythema size and the dielectric constant values
Eligibility Criteria
You may qualify if:
- Patients 18 years or older;
- Coming for intra-cutaneous allergy scratch test;
- Gender: male and female.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Expert Center for Lymphovascular Medicine Nij Smellinghe Hospital
Drachten, Provincie Friesland, 9202 NN, Netherlands
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert J Damstra, MD PhD
Nij Smellinghe Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- dermatologist MD PhD
Study Record Dates
First Submitted
March 27, 2013
First Posted
April 16, 2013
Study Start
March 1, 2013
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
June 11, 2013
Record last verified: 2013-06