Measuring Skin Elasticity in Lymphedema Patients

Lymphedema Clinical Trial

Official title:

Measuring Skin Elasticity in Lymphedema Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03313999
• Other study ID #: 2017P-000378
• Status: Withdrawn
• Phase: N/A
• Start date: February 18, 2018
• Est. completion date: June 1, 2023

Study information

• Verified date: June 2023
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diagnoses Disease
• Lymphedema

Intervention

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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Durometer Measurement	Value providing measure for the viscoelastic properties of skin including firmness and mechanical creep.	Enrollment (3 years)