Status:
COMPLETED
Comparative Trial in Compression Therapy in Leg Lymphedema
Lead Sponsor:
Nij Smellinghe Hosptial
Conditions:
Leg Lymphedema
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 Tric...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00665379
Start Date
April 1 2008
End Date
May 1 2009
Last Update
May 22 2012
Active Locations (1)
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1
Nij Smellinghe hospital
Drachten, Provincie Friesland, Netherlands, 9202NN