Prospective, Randomized Controlled Trial Comparing the Effect of CircAid(R) Juxta-Fit(tm) Versus Trico Bandages in the Treatment of Leg Lymphedema
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Efficacy of a device initial made for the maintenance treatment phase, which is now used in the initial treatment phase during 24 hour
研究概览
简要总结
Juxta-Fit is used for compression treatment. Juxta-Fit is an inelastic compression device which can be easily adjusted to the circumference of the limb and is usually used during the maintenance phase of lymphedema treatment. The aim of the study is to assess the effectiveness of Juxta-Fit in the initial treatment phase of leg lymphedema compared to the traditional treatment with Trico bandages in relation to interface pressure and to explore if self-management by Juxta fit is efficient after a short demonstration. Data are collected at 0-2-24 hours
详细描述
Application of marketed compression systems (Juxta-Fit or Trico bandages) used for treatment by trained specialists with assessment of the interface pressure and volume reduction. For the first two hours, bandages and Juxta fit will be applied by experienced medical staff and the use of the juxta-fit device will be explained to the patient. Thereafter the devices will be removed and patients in the Juxta fit group will apply the device themselves in the treatment. In this second phase after 2 hours, patients may adjust the Juxta-Fit according to their needs and comfort when they feel the device is getting too loose as activity of self-management during 24 hours. The patient will document this in a diary.
Detailed measuring data:
Volumetry:
Measurements after 0h, 2h and 24 h by using classic water displacement apparatus.
Pressure:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Gender: male or female
- •More than 18 years of age
- •Patients with distal lymphedema of the leg requiring multilayer lymphedema bandaging of the leg stage 2/3 (pitting component)
- •The patient is able to understand the study and is willing to give written informed consent to the study.
排除标准
- •Allergy to one of the used materials
- •Proximal lymphedema (involvement of thigh, genitalia)
- •Severe systemic diseases causing peripheral edema
- •Acute superficial or deep vein thrombosis
- •Arterial occlusive disease (stadium II, III or IV) Ankle Brachial Pulse Index (ABPI) <0,8
- •Local infection in the therapy area
- •Auto-immunological disorders or vasculitis
- •Use of systemic corticosteroids
- •Inability to don, doff, and adjust the Juxta-Fit
- •If the ankle circumference around the malleoli is greater than 38cm or if the difference between the arch circumference and the circumference around the base of the toes is greater than 7cm.
结局指标
主要结局
Efficacy of a device initial made for the maintenance treatment phase, which is now used in the initial treatment phase during 24 hour
时间窗: short term study during 26 hours
次要结局
- Quality of life (Visual Analog Scale) and number of self-management interventions by the patient in the study group(short term study during 26 hours)
研究者
R.J. Damstra
MD PhD deramtologist
Nij Smellinghe Hosptial