Near-infrared Fluorescence Lymphatic Imaging Assessment of Lymphatic Response to Pneumatic Back/Neck Lymphatic Drainage Delivered by a Pneumatic Manual Lymphatic Drainage Device
Study Details
Study Description
Brief Summary
The purpose of this study is to objectively assess lymphatic function before, during, and immediately after Neuroglide treatment in lower trunk and leg lymphatic vessels, torso, axillary regions, inguinal regions, upper extremities, and cervical/neck and to determine any VAS (Visual Analog Scale, a commonly used measure of pain perception) score change after Neuroglide treatment.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pneumatic Compression Therapy (PCT)
|
Drug: Indocyanine green (ICG) dye
ICG (25 mg vial) will be reconstituted with 10 ml sterile water provided by the manufacturer; further dilutions will be made in sterile saline just prior to administration. The final concentration of 0.32 millimolar (mM) will provide 25 μg ICG/injection, with each injection of 0.1 cc to be made . Up to 30 intradermal injections using conventional 30- or 31-gauge needles will be administered to each subject, for a maximum dose of 750 ug ICG, over 200 times less than the maximum allowed dose. Injection sites will be cleaned with alcohol wipes before intradermal injection.
Device: NIRF-LI imaging
Near-infrared fluorescence lymphatic imaging (NIRF-LI) imaging will be done to assess the drainage of ICG laden lymph from ICG injection sites toward regional nodal basins for 60 minutes before, during and after the Neuroglide pad treatment
Device: Neuroglide pad
After injection of Indocyanine green (ICG) dye and NIRF-LI imaging the subject will lie on the Neuroglide pad for the one-hour PCT treatment session.
|
Outcome Measures
Primary Outcome Measures
- Change in frequency of lymphatic pulsing as assessed by the number of lymphatic pulses per minute in each region imaged [Baseline, during Neuroglide treatment ( 1 hour after NIRF-LI imaging ), 1 hour after PCT treatment]
Secondary Outcome Measures
- Change in pain as assessed by the Visual Analog Scale (VAS) [Baseline, 1 hour after PCT treatment, 4-8 weeks after imaging for data analysis completion]
This is scored from 1(no pain)-10( worst pain possible) a higher number indicating more pain
Eligibility Criteria
Criteria
Inclusion Criteria:
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ambulatory and possess all four limbs
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Female participants of childbearing potential must have a negative urine pregnancy test within 36 hours prior to study drug administration
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Female participants of childbearing potential must agree to use a medically accepted method of contraception for a period of one month following each imaging session in the study
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Weight less than 400 lbs
Exclusion Criteria:
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Women who are pregnant or breast-feeding
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Persons who are allergic to iodine or indocyanine green
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Heart failure, poorly controlled kidney disease (glomerular filtration rate <30 mls per minute), hypoproteinemia, pulmonary hypertension, or hypothyroidism
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Any circumstance where increased lymphatic or venous return is undesirable
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- The University of Texas Health Science Center, Houston
- Eva MedTech, Inc.
Investigators
- Principal Investigator: Melissa B Aldrich, PhD, MBA, The University of Texas Health Science Center, Houston
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSC-MS-23-0093