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

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ClinicalTrials.gov Identifier: NCT01068431
Recruitment Status : Completed
First Posted : February 15, 2010
Last Update Posted : December 5, 2012
Sponsor:
Information provided by (Responsible Party):
R.J. Damstra, Nij Smellinghe Hosptial

Tracking Information
First Submitted Date  ICMJE February 3, 2010
First Posted Date  ICMJE February 15, 2010
Last Update Posted Date December 5, 2012
Study Start Date  ICMJE February 2010
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01068431 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2010)
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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2010)
Quality of life (Visual Analog Scale) and number of selfmanagement interventions by the patient in the study group [ Time Frame: short term study during 26 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Short Term Effectiveness Study of Juxta-Fit Versus Trico Bandages in the Treatment of Leg Lymphedema
Official Title  ICMJE Prospective, Randomized Controlled Trial Comparing the Effect of CircAid(R) Juxta-Fit(tm) Versus Trico Bandages in the Treatment of Leg Lymphedema
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Lymphedema
Intervention  ICMJE Other: bandaging with trico as active controller
In general non-elastic bandaging is the compression treatment in lymphedema
Other Name: Trico bandages (BSNmedical)
Study Arms  ICMJE
  • Active Comparator: trico bandage
    Leg lymphedema stage 2-3
    Intervention: Other: bandaging with trico as active controller
  • Experimental: juxta fit compression device
    leg lymphedema stage 2/3
    Intervention: Other: bandaging with trico as active controller
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2010)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01068431
Other Study ID Numbers  ICMJE NS2NL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party R.J. Damstra, Nij Smellinghe Hosptial
Study Sponsor  ICMJE Nij Smellinghe Hosptial
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: RJ Damstra, MD PhD Nij Smellinghe Hospital
PRS Account Nij Smellinghe Hosptial
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP