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Comparative Trial in Compression Therapy in Leg Lymphedema
This study has been completed.
Study NCT00665379   Information provided by Nij Smellinghe Hosptial
First Received: April 17, 2008   Last Updated: June 22, 2009   History of Changes

April 17, 2008
June 22, 2009
April 2008
April 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00665379 on ClinicalTrials.gov Archive Site
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 ]
Same as current
 
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.

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

 
Interventional
Treatment, Open Label, Active Control, Parallel Assignment, Efficacy Study
Leg Lymphedema
  • Other: Regular Compression therapy (Trico bandages)
  • Other: New Compression therapy (C2L bandages)
  • Active Comparator: Regular compression therapy with non elastic trico bandaging
  • Active Comparator: New two layer compression bandage coban 2
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
30
May 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00665379
R.J. Damstra, MD, SLCN
NS1NL
Nij Smellinghe Hosptial
 
Principal Investigator: RJ Damstra, MD Nij smellinghe hospital
Study Director: H Partsch, PhD Private practice, wien
Nij Smellinghe Hosptial
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP