Health TrialsbyHealthPanel

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

ConditionLower Extremity Lymphedema
Trial statusRecruiting
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Advanced pneumatic compression device (APCD)

    Device

    Single APCD treatment session at visit 1

  • Advanced pneumatic compression device (APCD) with revised compression programming

    Device

    APCD with revised compression programming will be single treatment session at visit 2

  • Indocyanine Green (IC-Green)

    Drug

    Indocyanine Green dye will be used to assess primary endpoint

Treatment groups

5 Participants
are divided into 1 treatment group
Group A: Treatment groupExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Lymphatic anatomy

• The distance (cm) that lymph travels from injection sites

Time frame
Before and after 60-minute treatment in clinic with APCD
2

Lymphatic propulsion

• Number of lymph propulsion events per minute

Time frame
Before and after 60-minute treatment in clinic with APCD

Secondary outcomes

1

Evaluate swelling in treatment limbs

• Changes in leg circumferential measurements (cm)

Time frame
Before and after 60-minute treatment in clinic with APCD
2

Evaluate swelling in treatment limbs

Change in local water content (ratio of % water content in legs to reference site)

Time frame
Before and after 60-minute treatment in clinic with APCD
3

Adverse Events

• Adverse Event assessments

Time frame
Through completion of study at Visit 2, up to 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tactile Medical

Lead sponsor

Source ClinicalTrials.gov
Apply now