Comparative Trial in Compression Therapy in Leg Lymphedema

NCT00665379 | Completed

• 1 other identifier: NS1NL
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to study the effect of the 3M Coban 2 Layer Compression System (hereafter C2L) in the treatment of leg lymphedema compared to the traditional treatment with Trico bandages.

Conditions

Leg 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 interface pressure after application of two types of bandages.

  enrollment of 30 patients

Secondary Outcomes (1)

• Pressure drop after 2 hours and 24 hours of bandaging

  after application, at 2 hours and 24 hours after application of bandage

Study Arms (2)

1

ACTIVE COMPARATOR

Regular compression therapy with non elastic trico bandaging

Other: Regular Compression therapy (Trico bandages)

2

ACTIVE COMPARATOR

New two layer compression bandage coban 2

Other: New Compression therapy (C2L bandages)

Interventions

Regular Compression therapy (Trico bandages) OTHER

Application of marketed Trico compression bandages used for treatment by trained specialists with assessment of the subbandage pressure and volume reduction. The bandages are applicated in patients with leg lymphedema at t=0 hour, t=2 hours. Comparison is made at t=2 hours, t= 24 hours

Also known as: trico bandages

1

New Compression therapy (C2L bandages) OTHER

Application of marketed compression bandages C2L used for treatment by trained specialists with assessment of the subbandage pressure and volume reduction. he bandages are applicated in patients with leg lymphedema at t=0 hour, t=2 hours. Comparison is made at t=2 hours, t= 24 hours

Also known as: coban 2

2

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
• 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 against one of the used materials
• Proximal lymphedema (involvement of thigh, genitalia)
• Severe systemic diseases causing peripheral oedema
• Acute superficial or deep vein thrombosis
• Arterial occlusive disease (stadium II, III or IV) or arm/leg blood pressure index (ALPI)\<0,8
• Local infection in the therapy area
• Auto-immunological disorders or vasculitis
• Use of systemic corticosteroids

Sponsors & Collaborators

• Nij Smellinghe Hosptial: lead

Study Sites (1)

Nij Smellinghe hospital

Drachten, Provincie Friesland, 9202NN, Netherlands

Location

Study Officials

• RJ Damstra, MD

  Nij Smellinghe Hospital

  PRINCIPAL INVESTIGATOR

• H Partsch, PhD

  Private practice, wien

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: April 17, 2008
• First Posted: April 23, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 22, 2012

Record last verified: 2012-05

Locations

NL (1)