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Measuring Skin Elasticity in Lymphedema Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03313999
Recruitment Status : Recruiting
First Posted : October 19, 2017
Last Update Posted : March 24, 2023
Sponsor:
Information provided by (Responsible Party):
Dhruv Singhal, Beth Israel Deaconess Medical Center

Study Description
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Brief Summary:
This protocol will utilize the lymphedema indentometer, or durometer (a novel, noninvasive piece of equipment that measures skin elasticity), to better characterize disease progression in patients with lymphedema. Beth Israel Deaconess Medical Center patients who undergo treatment of lymphedema will be candidates for this noninvasive test. This device and the data it generates will help understand the incidence of lymphedema at Beth Israel Deaconess Medical Center compared to national data and the outcomes of surgical treatment of lymphedema.

Condition or disease Intervention/treatment Phase
Diagnoses Disease Lymphedema Device: Lymphedema Indentometer Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arms and Interventions
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Arm Intervention/treatment
Durometer Measurement
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


Outcome Measures
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Primary Outcome Measures :
  1. Durometer Measurement [ Time Frame: Enrollment (3 years) ]
    Value providing measure for the viscoelastic properties of skin including firmness and mechanical creep.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients evaluated by the Beth Israel Deaconess Medical Center Lymphedema team with a diagnosis of lymphedema OR determined to be at risk of developing Lymphedema in any of their extremities
  • Patients must be over 18 years of age
  • Patients must be willing and capable to provide informed consent
  • Patients must speak English

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Angela Chen, BS 617-632-7043 achen22@bidmc.harvard.edu
Contact: Dhruv Singhal, MD 617-632-7855 dsinghal@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Contact: Dhruv Singhal, MD    617-632-7855      
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Dhruv Singhal, MD Beth Israel Deaconess Medical Center
More Information
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Responsible Party: Dhruv Singhal, Associate Professor, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03313999    
Other Study ID Numbers: 2017P-000378
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: March 24, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data from this study's data repository may be accessed by investigators interested in using the repository for research purposes. To access the data, investigator(s) will need to obtain Institutional Review Board approval of their protocol and submit their protocol to Dhruv Singhal, MD for review. Dr. Singhal will review the request for feasibility, scientific validity, and proper regulatory approvals. Only once the investigator(s) have received written Institutional Review Board approval, written approval from Dr. Singhal, and, if necessary, completed a material transfer agreement will they be given access to data from the repository. Dr. Singhal is uniquely suited to review requests to use repository data as he is a pioneer in the study and treatment of lymphedema and familiar with all information contained in the database.
Supporting Materials: Study Protocol
Time Frame: Researchers will only have access to information in the study's database for the duration of their Institutional Review Board approval.
Access Criteria: After the interested investigator(s) receive Institutional Review Board approval and approval from Dr. Singhal, the study team will securely send the data to the requesting investigator. Any requesting investigator will receive only durometer measurements, lymphedema characteristics and demographic information from the database. In all cases the requesting investigator will receive only de-identified data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Dhruv Singhal, Beth Israel Deaconess Medical Center:
Lymphedema indentometer
Durometer
Additional relevant MeSH terms:
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Lymphedema
Lymphatic Diseases