Evaluation of Lymphatic Response to Treatment in Patients With Edema Secondary to Superficial Venous Disease
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Extent of Dermal Backflow
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •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.
排除标准
- •History of pelvic or lower extremity cancers
- •Systemic organ failure including heart failure
- •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
研究组 & 干预措施
Control Arm
Subjects will receive standard-of-care compression bandaging.
干预措施: Indocyanine Green near infrared fluorescence imaging (Combination Product)
Control Arm
Subjects will receive standard-of-care compression bandaging.
干预措施: Duplex ultrasound (Diagnostic Test)
Control Arm
Subjects will receive standard-of-care compression bandaging.
干预措施: compression wrap (Device)
Treatment Arm
Subjects will receive both standard-of-care compression bandaging AND daily treatments with an advanced pneumatic compression device.
干预措施: Indocyanine Green near infrared fluorescence imaging (Combination Product)
Treatment Arm
Subjects will receive both standard-of-care compression bandaging AND daily treatments with an advanced pneumatic compression device.
干预措施: Duplex ultrasound (Diagnostic Test)
Treatment Arm
Subjects will receive both standard-of-care compression bandaging AND daily treatments with an advanced pneumatic compression device.
干预措施: advanced pneumatic compression (Device)
Treatment Arm
Subjects will receive both standard-of-care compression bandaging AND daily treatments with an advanced pneumatic compression device.
干预措施: compression wrap (Device)
结局指标
主要结局
Extent of Dermal Backflow
时间窗: Assessed at Visit 1 and 2 (approximately 30 days apart)
The area of abnormal dermal lymphatic backflow in the leg.
Lymphatic pumping rate
时间窗: Assessed at Visit 1 and Visit 2 (approximately 30 days apart)
Number of pumping events observed per minute assessed in the medial ankle.
次要结局
- Correlation of CEAP score and lymphatic pumping rates(Assessed at Visit 1 and 2 (approximately 30 days apart))
- Correlation of CEAP score with extent of dermal backflow(Assessed at Visit 1 and 2 (approximately 30 days apart))
- Change in limb volume between arms.(Assessed at Visit 1 and 2 (approximately 30 days apart))
- Change in LLIS score between arms(Assessed at Visit 1 and 2 (approximately 30 days apart))
- Change in Venous Clinical Severity Score (VCSS) between arms(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))
- Change in limb volume between arms.(Assessed at Visit 1 and 2 (approximately 30 days apart))
- Correlation of CEAP score with extent of dermal backflow(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))
- Correlation of CEAP score and lymphatic pumping rates(Assessed at Visit 1 and 2 (approximately 30 days apart))
- Change in LLIS score between arms(Assessed at Visit 1 and 2 (approximately 30 days apart))
- Change in Venous Clinical Severity Score (VCSS) between arms(Assessed at Visit 1 and 2 (approximately 30 days apart))
研究者
John Rasmussen
Associate Professor
The University of Texas Health Science Center, Houston