Measuring Skin Elasticity in Lymphedema Patients

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2027

Interventions

  • 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.

Arms, Groups and Cohorts

  • Other: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Durometer Measurement
    • Time Frame: Enrollment (3 years)
    • Value providing measure for the viscoelastic properties of skin including firmness and mechanical creep.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beth Israel Deaconess Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dhruv Singhal, Associate Professor – Beth Israel Deaconess Medical Center
  • Overall Official(s)
    • Dhruv Singhal, MD, Principal Investigator, Beth Israel Deaconess Medical Center
  • Overall Contact(s)
    • Dhruv Singhal, MD, 617-632-7855, dsinghal@bidmc.harvard.edu

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