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

Phase 4

Completed

• Conditions: Lymphedema
• Interventions: Other: bandaging with trico as active controller

• Registration Number: NCT01068431
• Lead Sponsor: Nij Smellinghe Hosptial

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.

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-03
• Study First Submitted QC: 2010-02-12
• Study First Posted: 2010-02-15
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-04
• Last Update Posted: 2012-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
trico bandage	bandaging with trico as active controller	Leg lymphedema stage 2-3
juxta fit compression device	bandaging with trico as active controller	leg lymphedema stage 2/3

Primary Outcome Measures

Name	Time	Method
Efficacy of a device initial made for the maintenance treatment phase, which is now used in the initial treatment phase during 24 hour	short term study during 26 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Nij Smellinghe hospital; 🇳🇱 Drachten, Friesland, Netherlands