Evaluation of Lymphatic Response to Physiotherapy in Patients With Swelling Associated With Superficial Venous Disease

Официальное название

Evaluation of Lymphatic Response to Treatment in Patients With Edema Secondary to Superficial Venous Disease

Обзор

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.

Вмешательства

• Комбинированный продукт Indocyanine 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.
• Устройство advanced 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.
• Диагностический тест Duplex ultrasound
  Duplex ultrasound to measure venous reflux will be done at each visit.
• Устройство compression wrap
  A compression wrap, to provide 20-40 mm Hg of pressure, will be provided for daily use between visits (approximately 30 days).

Первичные конечные точки

• Extent of Dermal Backflow [Срок оценки: Assessed at Visit 1 and 2 (approximately 30 days apart)]
• Lymphatic pumping rate [Срок оценки: Assessed at Visit 1 and Visit 2 (approximately 30 days apart)]

Вторичные конечные точки (6)

• Correlation of CEAP score and lymphatic pumping rates [Срок оценки: Assessed at Visit 1 and 2 (approximately 30 days apart)]
• Correlation of CEAP score with extent of dermal backflow [Срок оценки: Assessed at Visit 1 and 2 (approximately 30 days apart)]
• Change in limb volume between arms. [Срок оценки: Assessed at Visit 1 and 2 (approximately 30 days apart)]
• Change in LLIS score between arms [Срок оценки: Assessed at Visit 1 and 2 (approximately 30 days apart)]
• Change in Venous Clinical Severity Score (VCSS) between arms [Срок оценки: Assessed at Visit 1 and 2 (approximately 30 days apart)]
• Change in patient reported outcomes between arms [Срок оценки: Assessed at Visit 1 and 2 (approximately 30 days apart)]

Критерии участия

Критерии включения

• Participant >18 years of age
• 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).
• Participant must provide informed consent
• Participant is willing and able to fulfill study timeline
• Participant is a candidate for APCD treatment per the FTP indications
• Lymphatic dysfunction is observed, using NIRF-LI, in affected limb.

Критерии исключения

• History of pelvic or lower extremity cancers
• Systemic organ failure including heart failure
• BMI >35
• Previous endovascular or open vascular interventions
• Patients with known, or family history of, primary lymphedema
• Prior use of advanced pneumatic compression device, or complete decongestive therapy (CDT) on the lower extremities
• Peripheral arterial disease with ABI <0.8
• Participants with deep venous obstruction
• Skin disease not related to CVD
• Participants with iodine allergies including patients with shellfish allergy who may be allergic to iodine that may be in the ICG formulation
• Females who are pregnant or breastfeeding
• Females with the intent of becoming pregnant within 30 days after participation in final imaging session

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• University of Texas Health Science Center at Houston/UTPhysicians — Houston

Идентификаторы

NCT: NCT07165340 · HSC-MS-25-0191

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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