Comparative Trial in Compression Therapy in Leg Lymphedema
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00665379|
Recruitment Status : Completed
First Posted : April 23, 2008
Last Update Posted : May 22, 2012
|Condition or disease||Intervention/treatment||Phase|
|Leg Lymphedema||Other: Regular Compression therapy (Trico bandages) Other: New Compression therapy (C2L bandages)||Not Applicable|
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:
Measurements after 0h, 2h and 24 h by using classic water displacement apparatus.
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 (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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.|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||May 2009|
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
- volume decrease in relation to interface pressure after application of two types of bandages. [ Time Frame: enrollment of 30 patients ]
- Pressure drop after 2 hours and 24 hours of bandaging [ Time Frame: after application, at 2 hours and 24 hours after application of bandage ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00665379
|Nij Smellinghe hospital|
|Drachten, Friesland, Netherlands, 9202NN|
|Principal Investigator:||RJ Damstra, MD||Nij Smellinghe Hospital|
|Study Director:||H Partsch, PhD||Private practice, wien|