Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTactile Medical

About this trial

The goal of this pilot study is to learn if a revised method of compression improves lymphatic function compared to the current method of compression. The main questions:

• Does the revised method of compression improve lymph movement and lymphatic propulsion?

Eligibility criteria

Qualifiers

18 years of age or older

A diagnosis of active lower extremity lymphedema, as assessed by medical history

Participant is a candidate for APCD treatment per the Flexitouch Plus indications for use

Must be able to provide informed consent prior to study participation

Disqualifiers

Heart failure (acute pulmonary edema, decompensated acute heart failure)

Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)

Severe peripheral artery disease (critical limb ischemia, including ischemic rest pain, arterial wounds or gangrene)

Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) on the trunk or lower extremities

Trial design

Treatments tested in this trial

  • Advanced pneumatic compression device (APCD)
  • Advanced pneumatic compression device (APCD) with revised compression programming
  • Indocyanine Green (IC-Green)

Treatment groups

5 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators