Chronic Venous Disease
Conditions
Keywords
near-infrared fluorescence lymphatic imaging, lymphatic imaging, pneumatic compression therapy, indocyanine green, chronic venous disease
Brief summary
This study seeks to demonstrate the effect of advanced pneumatic compression in treatment naïve patients with CEAP C3 and C4 chronic venous disease. The main questions it aims to answer are: * Does lymphatic treatment improve lymphatic function following \ 30 days of advanced pneumatic compression device therapy? * Does lymphatic dysfunction correlate with CEAP score and venous reflux times? Over the course of 30-45 days, participants will undergo two sessions of near-infrared fluorescence lymphatic imaging to assess whether advanced pneumatic compression treatment improves lymphatic (dys)function. Subjects will be divided into two groups, a treated and a control group. Both groups will receive standard-of-care compression bandaging. The treated group will also be asked to complete daily sessions of pneumatic compression therapy at home. At both imaging sessions, duplex ultrasound will also be used to assess venous reflux times. Researchers will compare the changes in lymphatic and venous (dys)function between the two groups to see if lymphatic function improves with pneumatic compression treatment and if they dysfunction is correlated with CEAP clinical score and venous reflux times.
Interventions
COMBINATION_PRODUCTIndocyanine Green near infrared fluorescence imaging
A total of 10 intradermal injections of 25 ug indocyanine green (ICG) in 0.1 mL saline are administered in the feet, medial ankles, lateral calves, and thigh. The total dose of ICG will not exceed 250 ug. After injection, the legs will be illuminated by the dim output of a 780 nm laser diode, and the resultant fluorescent signal emanating from ICG-laden lymph will be collected by a custom built near-infrared fluorescent lymphatic imager.
DEVICEadvanced pneumatic compression
The advanced pneumatic compression device (APCD) mimics manual lymphatic drainage, a light massage that stimulates lymphatic uptake and function and frequently prescribed for lymphedema therapy. Daily treatment will be prescribed for approximately 30 days.
DIAGNOSTIC_TESTDuplex ultrasound
Duplex ultrasound to measure venous reflux will be done at each visit.
DEVICEcompression wrap
A compression wrap, to provide 20-40 mm Hg of pressure, will be provided for daily use between visits (approximately 30 days).
Sponsors
Tactile Medical
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This is a blinded, prospective, 2-arm, randomized study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant \>18 years of age 2. Participant with an objective diagnosis of CEAP Class 3 or 4 superficial venous disease (superficial reflux time \>0.5 sec), with venous edema (revised VCSS score of 2 or 3 for edema). 3. Participant must provide informed consent 4. Participant is willing and able to fulfill study timeline 5. Participant is a candidate for APCD treatment per the FTP indications 6. Lymphatic dysfunction is observed, using NIRF-LI, in affected limb.
Exclusion criteria
1. History of pelvic or lower extremity cancers 2. Systemic organ failure including heart failure 3. BMI \>35 4. Previous endovascular or open vascular interventions 5. Patients with known, or family history of, primary lymphedema 6. Prior use of advanced pneumatic compression device, or complete decongestive therapy (CDT) on the lower extremities 7. Peripheral arterial disease with ABI \<0.8 8. Participants with deep venous obstruction 9. Skin disease not related to CVD 10. Participants with iodine allergies including patients with shellfish allergy who may be allergic to iodine that may be in the ICG formulation 11. Females who are pregnant or breastfeeding 12. Females with the intent of becoming pregnant within 30 days after participation in final imaging session
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extent of Dermal Backflow | Assessed at Visit 1 and 2 (approximately 30 days apart) | The area of abnormal dermal lymphatic backflow in the leg. |
| Lymphatic pumping rate | Assessed at Visit 1 and Visit 2 (approximately 30 days apart) | Number of pumping events observed per minute assessed in the medial ankle. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in limb volume between arms. | Assessed at Visit 1 and 2 (approximately 30 days apart) | Limb volume, determined from limb circumference measurements, will be assessed at both visits. |
| Change in LLIS score between arms | Assessed at Visit 1 and 2 (approximately 30 days apart) | Patient reported outcomes assessed using the Lymphedema Life Impact Scale (LLIS) at each visit and change determined after Visit 2. Possible scores range from 0 to 100 with a higher score indicating a greater impact of disease on quality of life. |
| Correlation of CEAP score and lymphatic pumping rates | Assessed at Visit 1 and 2 (approximately 30 days apart) | — |
| Change in patient reported outcomes between arms | Assessed at Visit 1 and 2 (approximately 30 days apart) | Patient reported outcomes assessed using the Lower Extremity Functional Scale (LEFS) at each visit and change determined after Visit 2. Possible scores range from 0 to 80 with a higher score indicating a greater impact of disease on limb functionality. |
| Change in Venous Clinical Severity Score (VCSS) between arms | Assessed at Visit 1 and 2 (approximately 30 days apart) | Venous Clinical Severity Score (VCSS) will be assessed at each visit. Possible scores range from 0 to 30 with a higher score indicating a greater severity of vascular disease. |
| Correlation of CEAP score with extent of dermal backflow | Assessed at Visit 1 and 2 (approximately 30 days apart) | — |
Countries
United States
Outcome results
None listed