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Comparative Trial to Monitor Interface Pressure in Relation to Volume Change in Leg Lymphoedema

NCT01828606 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-02-10

No results posted yet for this study

Summary

Although there is no doubt about the need for compression therapy in lymphoedema, it is not investigated in much detail how much pressure is needed to get optimum volume reduction. New research suggests that there is obviously an upper pressure limit beyond further increase of pressure seems contra productive. This upper limit is around 30-40 mm Hg of initial pressure exerted by inelastic bandages on the upper and around 50-60 mm Hg on the lower extremity. This study is designed to investigate the effect of pressure on %volume reduction of leg lymphoedema with 2 bandages which are very comparable in product properties (slippage, stiffness, etc.), but differ in their pressure exerted to the limb.

Conditions

  • Lymphedema

Interventions

DEVICE

coban 2 system

All centres will perform the pressure measurements with Picopress, Microlab Elettronica, Italy For mobility measurements all centres will be supplied with pedometers. For perometry the centres will use their own equipment According to protocol the materials are applied to the whole leg and the measuring devices are put in place

DEVICE

coban lite system

All centres will perform the pressure measurements with Picopress, Microlab Elettronica, Italy For mobility measurements all centres will be supplied with pedometers. For perometry the centres will use their own equipment According to protocol the materials are applied to the whole leg and the measuring devices are put in place

Sponsors & Collaborators

  • Nij Smellinghe Hosptial

    lead OTHER

Principal Investigators

  • RJ Damstra, MD PhD · Nij smellinghe hospital, Netherlands

  • FJ Schingale, MD PhD · Lympho-Opt GmbH, Germany

  • H Partsch, MD PhD · professor with eremite, Austria

  • T Karlsmark, MD PhD · Bispebjerg Hospital, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-03-31
Completion
2014-09-30

Countries

  • Denmark
  • Germany
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01828606 on ClinicalTrials.gov