Comparative Trial in Compression Therapy in Leg Lymphedema

NCT ID: NCT00665379

Last Updated: 2012-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-05-31

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.

Detailed Description

The goal of this prospective, randomized, controlled trial with CE marked product is to study the effectiveness (volume reduction) of 24-hour compression therapy for lymphedema, comparing C2L and Trico bandaging. Therefore 30 patients with leg lymphedema are included.

Application of marketed compression bandages (C2L or Trico bandages) used for treatment by trained specialists with assessment of the subbandage pressure and volume reduction.

Measurements are carried out at:

Volumetry:

Measurements after 0h, 2h and 24 h by using classic water displacement apparatus.

Pressure:

Measurements after 0h, 2h (pre and post bandage change) and 24 h;

• supine and standing to calculate the SSI;
• supine with and without dorsal flexion.

for the pressure measurement a Kikuhime (large pads) dice is used. At each new bandaging to document the SSI and the effect of dorsiflexion in the supine position

• The subbandage pressure is measured on the medial aspect of the lower leg at the transition of the gastrocnemius muscle into the Achilles' tendon (B1) (Partsch H. et al. Dermatol Surg 2006; 32: 224-233).
• Fix the sensor (sensor and tube sheathed with Cellona Soft Padding)

Statistical analysis; Analysis of variance (ANOVA) comparing volume, supine subbandage pressure with and without dorsiflexion, and SSI for the used bandages

Conditions

Leg Lymphedema

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Regular compression therapy with non elastic trico bandaging

Group Type: ACTIVE_COMPARATOR

Regular Compression therapy (Trico bandages)

Intervention Type: 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

2

New two layer compression bandage coban 2

Group Type: ACTIVE_COMPARATOR

New Compression therapy (C2L bandages)

Intervention Type: 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

Interventions

Regular Compression therapy (Trico bandages)

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

Intervention Type: OTHER

New Compression therapy (C2L bandages)

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

Intervention Type: OTHER

Other Intervention Names

trico bandages; coban 2

Eligibility Criteria

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
• The patient is able to understand the study and is willing to give written informed consent to the study

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nij Smellinghe Hosptial

OTHER

Sponsor Role: lead

Responsible Party

R.J. Damstra

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

RJ Damstra, MD

Role: PRINCIPAL_INVESTIGATOR

Nij Smellinghe Hospital

H Partsch, PhD

Role: STUDY_DIRECTOR

Private practice, wien

Locations

Nij Smellinghe hospital

Drachten, Provincie Friesland, Netherlands

Countries

Netherlands

Other Identifiers

NS1NL

Identifier Type: -

Identifier Source: org_study_id