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Sponsored by: |
Nij Smellinghe Hosptial |
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Information provided by: | Nij Smellinghe Hosptial |
ClinicalTrials.gov Identifier: | NCT00665379 |
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 |
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Leg Lymphedema |
Other: Regular Compression therapy (Trico bandages) Other: New Compression therapy (C2L bandages) |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control, Parallel Assignment, Efficacy Study |
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. |
Estimated Enrollment: | 30 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Regular compression therapy with non elastic trico bandaging
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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.
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2: Active Comparator
New two layer compression bandage coban 2
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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.
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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;
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
Statistical analysis; Analysis of variance (ANOVA) comparing volume, supine subbandage pressure with and without dorsiflexion, and SSI for the used bandages
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: RJ Damstra, MD | 31-51-258-8215 | r.damstra@nijsmellinghe.nl |
Netherlands, Friesland | |
Nij Smellinghe hospital | Recruiting |
Drachten, Friesland, Netherlands, 9202NN | |
Contact: RJ Damstra, MD 31-51-258-8215 r.damstra@nijsmellinghe.nl |
Principal Investigator: | RJ Damstra, MD | Nij smellinghe hospital |
Study Director: | H Partsch, PhD | Private practice, wien |
Responsible Party: | SLCN ( R.J. Damstra, MD ) |
Study ID Numbers: | NS1NL |
Study First Received: | April 17, 2008 |
Last Updated: | April 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00665379 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
leg lymphedema volume measurement compression therapy interface pressure |
static stiffness index (SSI) volume change interface pressure |
Lymphedema Lymphatic Diseases Monensin |