Measuring Skin Elasticity in Lymphedema Patients

Beth Israel Lahey Health

Status: Terminated

Conditions: Lymphedema; Diagnoses Disease

Treatments: Device: Lymphedema Indentometer

Study type: Interventional

Funder types: Other

Identifiers

NCT03313999

2024P000442

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Durometer Measurement

Other group

Description:

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.

Treatment:

Device: Lymphedema Indentometer