Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment
Tactile Medical · NCT07613931
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Early Phase 1
- Target enrollment
- 5
- US sites recruiting
- 1
- Study start
- July 9, 2026
- Record last updated
- August 11, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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?
Being studied: Advanced pneumatic compression device (APCD); Advanced pneumatic compression device (APCD) with revised compression programming; Indocyanine Green (IC-Green)
Conditions: Lower Extremity Lymphedema
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Recruiting US locations
UTHealth Houston (The University of Texas Health Science Center at Houston)
Houston, TX 77030
Site contact: John Rasmussen, PhD · 713-500-3393 · John.Rasmussen@uth.tmc.edu
Study contacts (from the official record)
- Senior Vice President Marketing and Market Access · 1.833.382.2845 · clinicalresearch@tactilemedical.com
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