Revised compression method to treat lower limb lymphedema using an advanced pneumatic device

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase study compares a revised compression programming for an advanced pneumatic compression device against the current method to see if it improves lymphatic movement and propulsion in adults with active lower-extremity lymphedema. Participants may also receive a contrast dye-free lymphatic imaging approach. The trial will enroll adults who qualify for the device and can comply with the protocol at UTHealth Houston, under sponsor Tactile Medical. Safety considerations include common exclusion factors such as heart failure, acute venous disease, severe arterial disease, infection, active cancer in the leg drainage area, or eczema and scarring. The study uses a pilot design to gather initial signals of lymphatic function improvement and device tolerability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 18 years of age or older
2. A diagnosis of active lower extremity lymphedema, as assessed by medical history
3. Participant is a candidate for APCD treatment per the Flexitouch Plus indications for use
4. Must be able to provide informed consent prior to study participation
5. Willing and able to comply with the study protocol requirements and all study-related visit requirements

Exclusion Criteria:

1. Heart failure (acute pulmonary edema, decompensated acute heart failure)
2. Acute venous disease (acute thrombophlebitis, acute deep venous thrombosis, acute pulmonary embolism)
3. Severe peripheral artery disease (critical limb ischemia, including ischemic rest pain, arterial wounds or gangrene)
4. Active skin or limb infection/inflammatory disease (acute cellulitis, other uncontrolled skin or untreated inflammatory skin disease) on the trunk or lower extremities
5. Active cancer or metastasis in the lower extremity lymphatic watersheds
6. Eczema, rash, scarring, or extensive tattoos at imaging sites
7. Participant is pregnant or trying to become pregnant
8. Participants with a history of allergy to iodides, who may be susceptible to iodine present in ICG formulation
9. Patients exhibiting Grade 3 or higher on the CTCAE v6.0 superficial soft tissue fibrosis scale
10. Body Mass Index (BMI) ≥40
11. Participants unable to recline on their backs for up to 60 consecutive minutes and walk in place or tolerate assisted lower extremity movement for 5 minutes

Where it's running

• UTHealth Houston (The University of Texas Health Science Center at Houston)
  Houston, Texas, United States Recruiting

Study contacts

• Study coordinator: Senior Vice President Marketing and Market Access
• Email: clinicalresearch@tactilemedical.com
• Phone: 1.833.382.2845

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Respiratory and Relaxation Training added to standard complex decongestive therapy for lower leg lymphedema

  This trial tests whether adding breathing and relaxation practices to standard care helps people with secondary lower-extremity lymphedema feel and function better.

  Recruiting Toros University · Adana · NCT07697482

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.