Comparative Trial in Compression Therapy in Leg Lymphedema | NCT00665379

Studies
Comparative Trial in Compression Therapy in Leg Lymphedema

NCT00665379

Sponsor

Nij Smellinghe Hosptial

Status

Completed

Last Update Posted

May 22, 2012Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Leg Lymphedema

Interventions

Regular Compression therapy (Trico bandages)
New Compression therapy (C2L bandages)

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Apr 2009Actual

Completion Date

May 2009Actual

First Submitted Date

Apr 17, 2008

First Submission Date that Met QC Criteria

Apr 22, 2008

First Posted Date

Apr 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 19, 2012

Last Update Posted Date

May 22, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Regular compression therapy with non elastic trico bandaging	Other: Regular Compression therapy (Trico bandages)
2	Active Comparator	New two layer compression bandage coban 2	Other: New Compression therapy (C2L bandages)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Regular Compression therapy (Trico bandages)	Other	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
volume decrease in relation to interface pressure after application of two types of bandages.		enrollment of 30 patients

Secondary Outcomes

Measure	Description	Time Frame
Pressure drop after 2 hours and 24 hours of bandaging		after application, at 2 hours and 24 hours after application of bandage

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
RJ Damstra, MD	Nij Smellinghe Hospital	Principal Investigator
H Partsch, PhD	Private practice, wien	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nij Smellinghe hospital		Drachten	Provincie Friesland	9202NN	Netherlands