Evaluation of a Dual Action Pneumatic Compression Device: Patient Ease of Use and Comfort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 11
- 主要终点
- Ease of Use and Comfort for Subjects Using the ACTitouch System.
研究概览
简要总结
The purpose of this study is to determine the ease of use and comfort of the ACTitouch dual action pneumatic compression device in patients with unilateral or bilateral chronic venous insufficiency (CVI) with or without venous leg ulcers, as compared to standard compression.
详细描述
Subjects will be randomized to receive either the ACTitouch system or standard compression garments, and will respond to symptom surveys and quality of life surveys to assess comfort and ease of use of each. These will be conducted at Baseline, at Day 15 and Day 30.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Diagnosis of unilateral or bilateral CVI with or without leg ulcers
- •Documented history of low adherence to compression garment therapy
- •CEAP classification C3-C6
- •Leg circumferences within the following ranges: Ankle 12-44cm, calf 22-6m, below the knee 22-68cm
排除标准
- •History of skin sensitivity to any of the components of ACTitouch or compression garments
- •History of acute (deep vein thrombosis) DVT or (pulmonary embolism) PE within the last 3 months
- •Ankle Brachial Index (ABI) < 0.8
- •Acute thrombophlebitis
- •History of pulmonary edema or decompensated congestive heart failure
- •Currently has an active infection of the skin such as cellulitis requiring antibiotics
- •Poorly controlled diabetes with an HbA1c value of >10%
- •Exhibits any condition which, according to the PI, justifies the subjects exclusion from the study, such as a medical condition where an increase in venous or lymphatic return is undesirable.
- •Subjects with open ulcers must be able to follow their care regimen for ulcer healing concurrently with the assigned study regimen.
- •Participating in another clinical trial
- •Changes to medications that affect edema within the last 30 days
- •Currently pregnant or trying to become pregnant
研究组 & 干预措施
ACTitouch
ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.
干预措施: Dual Action Pneumatic Compression Device (Device)
Standard Compression Garments
Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.
干预措施: Standard Compression Garments (Device)
结局指标
主要结局
Ease of Use and Comfort for Subjects Using the ACTitouch System.
时间窗: 30 days
Ease of application and removal (donning and doffing) the treatment at the baseline visit. Comfort of treatment after the treatment was first applied.
次要结局
未报告次要终点