NCT03313999

Measuring Skin Elasticity in Lymphedema Patients

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diagnoses Disease
• Lymphedema

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-02-18
• Primary completion: 2025-06-02
• Completion: 2025-06-02
• First posted: 2017-10-19
• Last updated: 2025-10-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study