NCT07613931 · Tactile Medical
Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment
What this 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.
View original scientific description
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.
Interventions
DEVICE
Advanced pneumatic compression device (APCD)
Single APCD treatment session at visit 1
DEVICE
Advanced pneumatic compression device (APCD) with revised compression programming
APCD with revised compression programming will be single treatment session at visit 2
DRUG
Indocyanine Green (IC-Green)
Indocyanine Green dye will be used to assess primary endpoint
Primary outcome measures
Lymphatic anatomy
Time frame: Before and after 60-minute treatment in clinic with APCD
• The distance (cm) that lymph travels from injection sites
Lymphatic propulsion
Time frame: Before and after 60-minute treatment in clinic with APCD
• Number of lymph propulsion events per minute
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Houston, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations