Comparative Trial in Compression Therapy in Leg Lymphedema

Leg Lymphedema Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00665379
• Other study ID #: NS1NL
• Status: Completed
• Phase: N/A
• First received: April 17, 2008
• Last updated: May 19, 2012
• Start date: April 2008
• Est. completion date: May 2009

Study information

• Verified date: May 2012
• Source: Nij Smellinghe Hosptial
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

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;

• 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Lymphedema
• Lymphedema

Intervention

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
• 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

Locations

Country	Name	City	State
Netherlands	Nij Smellinghe hospital	Drachten	Friesland

Sponsors (1)

Lead Sponsor	Collaborator
Nij Smellinghe Hosptial

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	volume decrease in relation to interface pressure after application of two types of bandages.		enrollment of 30 patients	No
Secondary	Pressure drop after 2 hours and 24 hours of bandaging		after application, at 2 hours and 24 hours after application of bandage	No