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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
R.J. Damstra, Nij Smellinghe Hosptial
ClinicalTrials.gov Identifier:
NCT01068431
First received: February 3, 2010
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention Phase
Lymphedema
Other: bandaging with trico as active controller
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Prospective, Randomized Controlled Trial Comparing the Effect of CircAid(R) Juxta-Fit(tm) Versus Trico Bandages in the Treatment of Leg Lymphedema

Resource links provided by NLM:


Further study details as provided by Nij Smellinghe Hosptial:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life (Visual Analog Scale) and number of self-management interventions by the patient in the study group [ Time Frame: short term study during 26 hours ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: February 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: trico bandage
Leg lymphedema stage 2-3
Other: bandaging with trico as active controller
In general non-elastic bandaging is the compression treatment in lymphedema
Other Name: Trico bandages (BSNmedical)
Experimental: juxta fit compression device
leg lymphedema stage 2/3
Other: bandaging with trico as active controller
In general non-elastic bandaging is the compression treatment in lymphedema
Other Name: Trico bandages (BSNmedical)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01068431

Locations
Netherlands
Nij Smellinghe hospital
Drachten, Friesland, Netherlands, 9200 DA
Sponsors and Collaborators
Nij Smellinghe Hosptial
Investigators
Principal Investigator: RJ Damstra, MD PhD Nij Smellinghe hospital
  More Information

No publications provided

Responsible Party: R.J. Damstra, MD PhD deramtologist, Nij Smellinghe Hosptial
ClinicalTrials.gov Identifier: NCT01068431     History of Changes
Other Study ID Numbers: NS2NL
Study First Received: February 3, 2010
Last Updated: December 4, 2012
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by Nij Smellinghe Hosptial:
lymphedema
conservative treatment
compression therapy
interface pressure

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases

ClinicalTrials.gov processed this record on October 16, 2014