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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 17, 2008 | ||||||||
| Last Updated Date | June 22, 2009 | ||||||||
| Start Date ICMJE | April 2008 | ||||||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00665379 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Comparative Trial in Compression Therapy in Leg Lymphedema | ||||||||
| Official Title ICMJE | Prospective, Randomized Controlled Trial Comparing the Effect of 3M Coban 2 Layer Compression System Versus Trico Bandages in the Treatment of Leg Lymphedema. | ||||||||
| 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. |
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| 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;
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 |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Leg Lymphedema | ||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 30 | ||||||||
| Completion Date | May 2009 | ||||||||
| Primary Completion Date | April 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00665379 | ||||||||
| Responsible Party | R.J. Damstra, MD, SLCN | ||||||||
| Study ID Numbers ICMJE | NS1NL | ||||||||
| Study Sponsor ICMJE | Nij Smellinghe Hosptial | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Nij Smellinghe Hosptial | ||||||||
| Verification Date | June 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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