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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01068431
Recruitment Status : Completed
First Posted : February 15, 2010
Last Update Posted : December 5, 2012
Information provided by (Responsible Party):
R.J. Damstra, 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

Condition or disease Intervention/treatment Phase
Lymphedema Other: bandaging with trico as active controller Phase 4

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:


Measurements after 0h, 2h and 24 h by using classic water displacement apparatus.


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.


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (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
Study Start Date : February 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01068431

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Nij Smellinghe hospital
Drachten, Friesland, Netherlands, 9200 DA
Sponsors and Collaborators
Nij Smellinghe Hosptial
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Principal Investigator: RJ Damstra, MD PhD Nij Smellinghe Hospital
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Responsible Party: R.J. Damstra, MD PhD deramtologist, Nij Smellinghe Hosptial Identifier: NCT01068431    
Other Study ID Numbers: NS2NL
First Posted: February 15, 2010    Key Record Dates
Last Update Posted: December 5, 2012
Last Verified: December 2012
Keywords provided by R.J. Damstra, Nij Smellinghe Hosptial:
conservative treatment
compression therapy
interface pressure
Additional relevant MeSH terms:
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Lymphatic Diseases