Prospective, Randomized Controlled Trial Comparing the Effect of CircAid(R) Juxta-Fit(tm) Versus Trico Bandages in the Treatment of Leg Lymphedema
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Lymphedema
- Sponsor
- Nij Smellinghe Hosptial
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Efficacy of a device initial made for the maintenance treatment phase, which is now used in the initial treatment phase during 24 hour
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
R.J. Damstra
MD PhD deramtologist
Nij Smellinghe Hosptial
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Efficacy of a device initial made for the maintenance treatment phase, which is now used in the initial treatment phase during 24 hour
Time Frame: short term study during 26 hours
Secondary Outcomes
- 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)