Measuring Skin Elasticity in Lymphedema Patients

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 Overview

• Status: Withdrawn
• Conditions: Lymphedema; Diagnoses Disease
• Intervention / Treatment: Device: Lymphedema Indentometer

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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 Names: Durometer

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Investigators: Principal Investigator: Dhruv Singhal, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2018
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: October 14, 2017
• First Submitted That Met QC Criteria: October 14, 2017
• First Posted (Actual): October 19, 2017

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 28, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Lymphedema indentometer; Durometer
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: 2017P-000378

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: Researchers will only have access to information in the study's database for the duration of their Institutional Review Board approval.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• 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