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

NCT01828606 | Completed

• 2 other identifiers: NS6NLCLIN-PROT-EU-05-184776
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 3

Brief 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

Keywords

leg lymphedema; volume measurement; compression therapy; interface pressure; static stiffness index (SSI); volume change

Outcome Measures

Primary Outcomes (1)

• volume decrease in relation to pressure application of two types of bandages

  At each of the 8 visits the supine and standing pressure under the bandage is measured with a Picopress device at the B1, C and F positions. The patient will receive new bandaging twice a week. At those visits the volume is determined and a second pressure measurement is conducted 2 hours after bandage application. For safety assessment all adverse events will be documented. The total number of bandage changes could increase if bandage changes are required more often. On these occasions all measurements, which are required on a regular bandage change day, will be performed.

  1 week, 2 bandages changes

Secondary Outcomes (1)

• pressure drop profiles under 2 bandage types

  1 week

Study Arms (2)

Coban 2 system

EXPERIMENTAL

The two layer system is more stiff and the material is different designed

Device: coban 2 system; Device: coban lite system

coban lite systems

EXPERIMENTAL

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 2 system; Device: coban lite system

Interventions

coban 2 system DEVICE

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

Coban 2 system; coban lite systems

coban lite system DEVICE

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

Coban 2 system; coban lite systems

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Mobile males or females, age 18 years or older
• Subject is mobile and able to walk minimum 5000 steps
• Subject has unilateral or bilateral leg lymphoedema of primary or secondary origin
• Maximum leg circumference at C position is 60 cm or less
• Subject has more or equal than 5 mm pitting leg lymphoedema diagnosed as stage II or late stage II according to the International Society of Lymphology staging
• Subject requires intense bandaging therapy
• ABPI \>= 0.8
• Willing to give written informed consent and willing to comply with the study protocol

You may not qualify if:

• Known pregnancy
• Evidence of active cancer with potential or known risk of metastasis
• Cancer treatments (surgery, chemotherapy, radiotherapy) not completed at least 6 months prior to randomisation
• Lobes, that a proper bandage application is not possible
• Lobes in the area where a pressure sensor needs to be placed
• A period of intense daily bandaging within the last month
• Any oedema not directly related to lymph failure (e.g. related to heart, renal disease etc.)
• Diuretic treatments
• Paralysis or neuropathy of the legs
• Clinical infection of the legs (e.g. erysipelas)
• Postthrombotic syndrome and/or medical conditions that are contraindicated for compression therapy
• History of allergic reactions to study material
• Participation in any other prospective clinical study that can potentially interfere with this study

Sponsors & Collaborators

• Nij Smellinghe Hosptial: lead

Study Sites (3)

Dermato-venerologisk afd. og videncenter for sårheling D/S Bispebjerg Hospital

København NV, DK 2400, Denmark

Location

Lympho-Opt GmbH

Pommelsbrunn, 91224, Germany

Location

Nij Smellinghe hospital

Drachten, Provincie Friesland, 9202NN, Netherlands

Location

Related Links

• The foundation related to the expert centre organizing research
• General website form the Nij Smellinghe hospital

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• RJ Damstra, MD PhD

  Nij smellinghe hospital, Netherlands

  PRINCIPAL INVESTIGATOR

• FJ Schingale, MD PhD

  Lympho-Opt GmbH, Germany

  PRINCIPAL INVESTIGATOR

• H Partsch, MD PhD

  professor with eremite, Austria

  STUDY CHAIR

• T Karlsmark, MD PhD

  Bispebjerg Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: April 7, 2013
• First Posted: April 10, 2013
• Study Start: April 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 10, 2015

Record last verified: 2014-02

Locations

DK (1); DE (1); NL (1)