💬In plain words
What the trial is, and whether it could suit you
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?
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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
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