NCT04116099

CVR Registry Evaluating Flexitouch Plus and Conservative Care vs Conservative Care Only for Treatment of Lymphedema

An Observational Registry Evaluating the Flexitouch® Plus in Vascular Clinic Patients With Lower Extremity Lymphedema

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 63 (actual)
• Sponsor: Tactile Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Subjects with lower extremity lymphedema will be prescribed, per standard of care, to either Flexitouch Plus with conservative care or conservative care only and be followed for 12 months.

Detailed description

Conservative care treatment for lymphedema may include use of compression, manual lymphatic drainage (MLD, performed either by a therapist or self-MLD), exercises and skin care. Subjects presenting to a vein clinic (Center for Vein Restoration or CVR) with lymphedema of the lower extremity/ies may receive a standard-of-care prescription for conservative care or for the Flexitouch Plus pneumatic compression device along with conservative care. Subjects will be followed (by phone and in clinic) for 12 months after initiating treatment for venous- and lymphedema-related complications, unscheduled visits, changes in quality of life measures and edema measures, skin changes, and changes to wounds (if present).

Conditions

• Lymphedema

Interventions

Type	Name	Description
OTHER	Conservative care	May include graduated compression, MLD performed by a licensed therapist, self-MLD, and instruction on exercise and skin care.
DEVICE	Flexitouch Plus	Flexitouch Plus treatment.

Timeline

• Start date: 2019-10-10
• Primary completion: 2021-11-24
• Completion: 2021-11-24
• First posted: 2019-10-04
• Last updated: 2022-03-31

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study