NCT07613931招募中1 期
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
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 5
- 试验地点
- 1
研究概览
简要总结
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?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Treatment group
Experimental
干预措施: Advanced pneumatic compression device (APCD) (Device)
Treatment group
Experimental
干预措施: Advanced pneumatic compression device (APCD) with revised compression programming (Device)
Treatment group
Experimental
干预措施: Indocyanine Green (IC-Green) (Drug)
研究者
研究点 (1)
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