NCT03313999

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 19, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

February 18, 2018

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2025

Completed
Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

7.3 years

First QC Date

October 14, 2017

Last Update Submit

October 15, 2025

Conditions

Diagnoses DiseaseLymphedema

Keywords

Lymphedema indentometerDurometer

Outcome Measures

Primary Outcomes (1)

  • Durometer Measurement

    Value providing measure for the viscoelastic properties of skin including firmness and mechanical creep.

    Enrollment (3 years)

Study Arms (1)

Durometer Measurement

OTHER

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

Interventions

Lymphedema IndentometerDEVICE

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.

Also known as: Durometer
Durometer Measurement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Dhruv Singhal, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

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
Associate Professor

Study Record Dates

First Submitted

October 14, 2017

First Posted

October 19, 2017

Study Start

February 18, 2018

Primary Completion

June 2, 2025

Study Completion

June 2, 2025

Last Updated

October 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
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.

Locations

US(1)