Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment

Официальное название

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

Обзор

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?

Вмешательства

• Устройство Advanced pneumatic compression device (APCD)
  Single APCD treatment session at visit 1
• Устройство Advanced pneumatic compression device (APCD) with revised compression programming
  APCD with revised compression programming will be single treatment session at visit 2
• Препарат Indocyanine Green (IC-Green)
  Indocyanine Green dye will be used to assess primary endpoint

Первичные конечные точки

• Lymphatic anatomy [Срок оценки: Before and after 60-minute treatment in clinic with APCD]
• Lymphatic propulsion [Срок оценки: Before and after 60-minute treatment in clinic with APCD]

Вторичные конечные точки (3)

• Evaluate swelling in treatment limbs [Срок оценки: Before and after 60-minute treatment in clinic with APCD]
• Evaluate swelling in treatment limbs [Срок оценки: Before and after 60-minute treatment in clinic with APCD]
• Adverse Events [Срок оценки: Through completion of study at Visit 2, up to 4 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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
• 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

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

США · 1 центр

• UTHealth Houston (The University of Texas Health Science Center at Houston) — Houston

Идентификаторы

NCT: NCT07613931 · 7010

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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