Measuring Skin Elasticity in Lymphedema Patients

Not Applicable

Recruiting

• Conditions: Diagnoses Disease; Lymphedema
• Interventions: Device: Lymphedema Indentometer

• Registration Number: NCT03313999
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-14
• Study First Submitted QC: 2017-10-14
• Study First Posted: 2017-10-19
• Study Start: 2018-02-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-31
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Durometer Measurement	Lymphedema Indentometer	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States