Comparative Trial in Compression Therapy in Leg Lymphedema

Prospective, Randomized Controlled Trial Comparing the Effect of 3M Coban 2 Layer Compression System Versus Trico Bandages in the Treatment of Leg Lymphedema.

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.

Study Overview

• Status: Completed
• Conditions: Leg Lymphedema
• Intervention / Treatment: Other: Regular Compression therapy (Trico bandages); Other: New Compression therapy (C2L 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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Friesland
    • Drachten, Friesland, Netherlands, 9202NN
      • Nij Smellinghe Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Regular compression therapy with non elastic trico bandaging	Other: 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; Other Names: trico bandages
Active Comparator: 2; New two layer compression bandage coban 2	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; Other Names: coban 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
volume decrease in relation to interface pressure after application of two types of bandages.	enrollment of 30 patients

Secondary Outcome Measures

Outcome Measure	Time Frame
Pressure drop after 2 hours and 24 hours of bandaging	after application, at 2 hours and 24 hours after application of bandage

Collaborators and Investigators

• Sponsor: Nij Smellinghe Hosptial
• Investigators: Principal Investigator: RJ Damstra, MD, Nij Smellinghe Hospital; Study Director: H Partsch, PhD, Private practice, wien

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: April 17, 2008
• First Submitted That Met QC Criteria: April 22, 2008
• First Posted (Estimate): April 23, 2008

Study Record Updates

• Last Update Posted (Estimate): May 22, 2012
• Last Update Submitted That Met QC Criteria: May 19, 2012
• Last Verified: May 1, 2012

More Information

Terms related to this study

• Keywords: leg lymphedema; volume measurement; compression therapy; interface pressure; static stiffness index (SSI); volume change
• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: NS1NL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No