Comparative Trial in Compression Therapy in Leg Lymphedema - Full Text View

Sponsor:	Nij Smellinghe Hosptial
Information provided by:	Nij Smellinghe Hosptial
ClinicalTrials.gov Identifier:	NCT00665379

Purpose

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.

Condition	Intervention
Leg Lymphedema	Other: Regular Compression therapy (Trico bandages) Other: New Compression therapy (C2L bandages)

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Prospective, Randomized Controlled Trial Comparing the Effect of 3M Coban 2 Layer Compression System Versus Trico Bandages in the Treatment of Leg Lymphedema.

Resource links provided by NLM:

Genetics Home Reference related topics: lymphedema-distichiasis syndrome

MedlinePlus related topics: Lymphedema

Drug Information available for: Monensin Monensin sodium

U.S. FDA Resources

Further study details as provided by Nij Smellinghe Hosptial:

Primary Outcome Measures:

volume decrease in relation to interface pressure after application of two types of bandages. [ Time Frame: enrollment of 30 patients ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pressure drop after 2 hours and 24 hours of bandaging [ Time Frame: after application, at 2 hours and 24 hours after application of bandage ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	April 2008
Study Completion Date:	May 2009
Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: coban 2

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00665379

Locations

Netherlands
Nij Smellinghe hospital
Drachten, Friesland, Netherlands, 9202NN

Sponsors and Collaborators

Nij Smellinghe Hosptial

Investigators

Principal Investigator:	RJ Damstra, MD	Nij smellinghe hospital
Study Director:	H Partsch, PhD	Private practice, wien

More Information

No publications provided

Responsible Party:	R.J. Damstra, MD, SLCN
ClinicalTrials.gov Identifier:	NCT00665379 History of Changes
Other Study ID Numbers:	NS1NL
Study First Received:	April 17, 2008
Last Updated:	June 22, 2009
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Nij Smellinghe Hosptial:

leg lymphedema
volume measurement
compression therapy

interface pressure
static stiffness index (SSI)
volume change

Additional relevant MeSH terms:

Lymphedema
Lymphatic Diseases
Monensin
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Ionophores
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012