Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment
Recruiting now · Early Phase 1
Conditions studied: Lower Extremity Lymphedema
In brief
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?
Key facts
- Study ID
- NCT07613931
- Run by
- Tactile Medical
- People needed
- 5
- Starts
- 2026-07-01
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2026-07-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Willing and able to comply with the study protocol requirements and all study-related visit requirements
You may not qualify if…
- 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
- Active cancer or metastasis in the lower extremity lymphatic watersheds
- Eczema, rash, scarring, or extensive tattoos at imaging sites
- Participant is pregnant or trying to become pregnant
- Participants with a history of allergy to iodides, who may be susceptible to iodine present in ICG formulation
- Patients exhibiting Grade 3 or higher on the CTCAE v6.0 superficial soft tissue fibrosis scale
- Body Mass Index (BMI) ≥40
- 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 is running
- UTHealth Houston (The University of Texas Health Science Center at Houston) — Houston, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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