Lower Extremity LymphedemaEarly Phase 1NCT07613931
Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment
A Early Phase 1 study testing Advanced pneumatic compression device (APCD), Advanced pneumatic compression device (APCD) with revised compression programming and Indocyanine Green (IC-Green) in people with Lower Extremity Lymphedema, run by Tactile Medical at 1 site in United States.
Trial summary
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? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Extremity Lymphedema
- What is being tested?
- Advanced pneumatic compression device (APCD), Advanced pneumatic compression device (APCD) with revised compression programming and Indocyanine Green (IC-Green)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2026to Sep 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Senior Vice President Marketing and Market Access contact
United States1 site, 1 recruiting
- Recruiting
UTHealth Houston (The University of Texas Health Science Center at Houston)
Houston, Texas, 77030
John Rasmussen, PhD, 713-500-3393, John.Rasmussen@uth.tmc.edu
About this study
Official title: A Pilot Study to Evaluate and Compare Lymphatic Transport in Patients With Lower Extremity Lymphedema Between Flexitouch Plus® and Flexitouch Plus® With Novel Multi-Chamber Firmware
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?
- Conditions
- Lower Extremity Lymphedema
- Being tested
- Advanced pneumatic compression device (APCD), Advanced pneumatic compression device (APCD) with revised compression programming, Indocyanine Green (IC-Green)
- Keywords
- lymphedema, lower extremity
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced pneumatic compression device (APCD)Device
Single APCD treatment session at visit 1
Advanced pneumatic compression device (APCD) with revised compression programmingDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Device: Advanced pneumatic compression device (APCD); Device: Advanced pneumatic compression device (APCD) with revised compression programming; Drug: Indocyanine Green (IC-Green) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lymphatic anatomy
- The distance (cm) that lymph travels from injection sites
Measured: Before and after 60-minute treatment in clinic with APCD
Lymphatic propulsion
- Number of lymph propulsion events per minute
Measured: Before and after 60-minute treatment in clinic with APCD
Secondary outcomes (3)
Evaluate swelling in treatment limbs
- Changes in leg circumferential measurements (cm)
Measured: Before and after 60-minute treatment in clinic with APCD
Evaluate swelling in treatment limbs
Change in local water content (ratio of % water content in legs to reference site)
Measured: Before and after 60-minute treatment in clinic with APCD
Adverse Events
- Adverse Event assessments
Measured: Through completion of study at Visit 2, up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start9 Jul 2026
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Extremity LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tactile Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613931
- Sponsor's protocol ID
- 7010
- Status last verified
- Aug 2026
- First submitted
- 4 May 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No: This is a pilot study.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Evaluate and Compare Lymphatic Transport in Patients With Lower Extremity Lymphedema Between Flexitouch Plus® and Flexitouch Plus® With Novel Multi-Chamber Firmware
- ClinicalTrials.gov ID
- NCT07613931
- Acronym / sponsor ID
- 7010
- Conditions
- Lower Extremity Lymphedema
- Keywords
- lymphedema, lower extremity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Tactile MedicalIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Device: Advanced pneumatic compression device (APCD), Device: Advanced pneumatic compression device (APCD) with revised compression programming, Drug: Indocyanine Green (IC-Green) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Advanced pneumatic compression device (APCD)Single APCD treatment session at visit 1 | Device | Treatment group |
| Advanced pneumatic compression device (APCD) with revised compression programmingAPCD with revised compression programming will be single treatment session at visit 2 | Device | Treatment group |
| Indocyanine Green (IC-Green)Indocyanine Green dye will be used to assess primary endpoint | Drug | Treatment group |
Primary outcome
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
3 secondary outcomes
Evaluate swelling in treatment limbs
Time frame: Before and after 60-minute treatment in clinic with APCD
Evaluate swelling in treatment limbs
Time frame: Before and after 60-minute treatment in clinic with APCD
Adverse Events
Time frame: Through completion of study at Visit 2, up to 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No. This is a pilot study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Senior Vice President Marketing and Market Access contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Advanced pneumatic compression device (APCD), Advanced pneumatic compression device (APCD) with revised compression programming and Indocyanine Green (IC-Green) in people with Lower Extremity Lymphedema, run by Tactile Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Senior Vice President Marketing and Market Access (1.833.382.2845, clinicalresearch@tactilemedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphatic anatomy (time frame: Before and after 60-minute treatment in clinic with APCD). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.