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

NCT01068431 | Completed Phase 4

• 1 other identifier: NS2NL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Lymphedema

Keywords

lymphedema; conservative treatment; compression therapy; interface pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

trico bandage

ACTIVE COMPARATOR

Leg lymphedema stage 2-3

Other: bandaging with trico as active controller

juxta fit compression device

EXPERIMENTAL

leg lymphedema stage 2/3

Other: bandaging with trico as active controller

Interventions

bandaging with trico as active controller OTHER

In general non-elastic bandaging is the compression treatment in lymphedema

Also known as: Trico bandages (BSNmedical)

juxta fit compression device; trico bandage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nij Smellinghe Hosptial: lead

Study Sites (1)

Nij Smellinghe hospital

Drachten, Provincie Friesland, 9200 DA, Netherlands

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• RJ Damstra, MD PhD

  Nij Smellinghe Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD deramtologist

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: February 15, 2010
• Study Start: February 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: December 5, 2012

Record last verified: 2012-12

Locations

NL (1)