Measuring Skin Elasticity in Lymphedema Patients

Sponsor

Beth Israel Deaconess Medical Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT03313999

Collaborator

(none)

2,000

Enrollment

Location

Arm

117.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Feb 18, 2018

Anticipated Primary Completion Date :

Dec 1, 2027

Anticipated Study Completion Date :

Dec 1, 2027

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Durometer Measurement [Enrollment (3 years)]
Value providing measure for the viscoelastic properties of skin including firmness and mechanical creep.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dhruv Singhal, Associate Professor, Beth Israel Deaconess Medical Center

ClinicalTrials.gov Identifier:

NCT03313999

Other Study ID Numbers:

2017P-000378

First Posted:

Oct 19, 2017

Last Update Posted:

Feb 28, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Dhruv Singhal, Associate Professor, Beth Israel Deaconess Medical Center

Lymphedema indentometer

Durometer

Additional relevant MeSH terms:

Lymphedema

Study Results

No Results Posted as of Feb 28, 2022