Measuring Skin Elasticity in Lymphedema Patients
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|ClinicalTrials.gov Identifier: NCT03313999|
Recruitment Status : Suspended (Enrollment and other trial activities have temporarily paused due to COVID-19 and are expected to resume in the future; This is not a suspension of IRB approval)
First Posted : October 19, 2017
Last Update Posted : April 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diagnoses Disease Lymphedema||Device: Lymphedema Indentometer||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Measuring Skin Elasticity in Lymphedema Patients|
|Actual Study Start Date :||February 18, 2018|
|Estimated Primary Completion Date :||December 2027|
|Estimated Study Completion Date :||December 2027|
All patients participating in the study will receive standard of care treatment for their lymphedema. As part of the study they will be measured by the durometer in addition to other, standard diagnostics to further characterize their lymphedema progression.
Device: Lymphedema Indentometer
The subject will sit down. The machine will be placed over their extremity/affected region. They will then be told the machine will be activated. They may or may not feel the machine touch them. A small pressure will be applied to the skin surface for 4 seconds. The computer will record the skin elasticity as change in resistance to compression over time during these 4 seconds. The entire procedure will take about a minute or less, after which the standard of care visit with the physical therapist will continue.
Other Name: Durometer
- Durometer Measurement [ Time Frame: Enrollment (3 years) ]Value providing measure for the viscoelastic properties of skin including firmness and mechanical creep.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03313999
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Dhruv Singhal, MD||Beth Israel Deaconess Medical Center|