Short Term Effectiveness Study of Juxta-Fit Versus Trico Bandages in the Treatment of Leg Lymphedema

NCT ID: NCT01068431

Last Updated: 2012-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-08-31

Brief Summary

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

Detailed Description

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:

Measurements after 0h, 2h (pre and post system change) and 24 h at the B1 region:

• Supine and standing to calculate the Static Stiffness Index (SSI);
• Supine with and without dorsal flexion to calculate the Dynamic Stiffness index (DSI).

Circumference measurement as safety parameter At 5 cm above the upper part of the patella the circumference is measured at 0-2-24 hours to monitor eventual fluids shift.

Questionnaire

• The Visual Analog Scale (VAS) is used at 0 (pre-treatment), 2 and 24 hours to register the comfort of the materials used.

Conditions

Lymphedema

Keywords

lymphedema; conservative treatment; compression therapy; interface pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

trico bandage

Leg lymphedema stage 2-3

Group Type: ACTIVE_COMPARATOR

bandaging with trico as active controller

Intervention Type: OTHER

In general non-elastic bandaging is the compression treatment in lymphedema

juxta fit compression device

leg lymphedema stage 2/3

Group Type: EXPERIMENTAL

bandaging with trico as active controller

Intervention Type: OTHER

In general non-elastic bandaging is the compression treatment in lymphedema

Interventions

bandaging with trico as active controller

In general non-elastic bandaging is the compression treatment in lymphedema

Intervention Type: OTHER

Other Intervention Names

Trico bandages (BSNmedical)

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nij Smellinghe Hosptial

OTHER

Sponsor Role: lead

Responsible Party

R.J. Damstra

MD PhD deramtologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

RJ Damstra, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Nij Smellinghe Hospital

Locations

Nij Smellinghe hospital

Drachten, Provincie Friesland, Netherlands

Countries

Netherlands

Other Identifiers

NS2NL

Identifier Type: -

Identifier Source: org_study_id