- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01068431
Short Term Effectiveness Study of Juxta-Fit Versus Trico Bandages in the Treatment of Leg Lymphedema
Prospective, Randomized Controlled Trial Comparing the Effect of CircAid(R) Juxta-Fit(tm) Versus Trico Bandages in the Treatment of Leg Lymphedema
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Application of marketed compression systems (Juxta-Fit or Trico bandages) used for treatment by trained specialists with assessment of the interface pressure and volume reduction. For the first two hours, bandages and Juxta fit will be applied by experienced medical staff and the use of the juxta-fit device will be explained to the patient. Thereafter the devices will be removed and patients in the Juxta fit group will apply the device themselves in the treatment. In this second phase after 2 hours, patients may adjust the Juxta-Fit according to their needs and comfort when they feel the device is getting too loose as activity of self-management during 24 hours. The patient will document this in a diary.
Detailed measuring data:
Volumetry:
Measurements after 0h, 2h and 24 h by using classic water displacement apparatus.
Pressure:
Measurements after 0h, 2h (pre and post system change) and 24 h at the B1 region:
- Supine and standing to calculate the Static Stiffness Index (SSI);
- Supine with and without dorsal flexion to calculate the Dynamic Stiffness index (DSI).
Circumference measurement as safety parameter At 5 cm above the upper part of the patella the circumference is measured at 0-2-24 hours to monitor eventual fluids shift.
Questionnaire
- The Visual Analog Scale (VAS) is used at 0 (pre-treatment), 2 and 24 hours to register the comfort of the materials used.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Friesland
-
Drachten, Friesland, Netherlands, 9200 DA
- Nij Smellinghe Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 stage 2/3 (pitting component)
- The patient is able to understand the study and is willing to give written informed consent to the study.
Exclusion criteria:
- Allergy to one of the used materials
- Proximal lymphedema (involvement of thigh, genitalia)
- Severe systemic diseases causing peripheral edema
- Acute superficial or deep vein thrombosis
- Arterial occlusive disease (stadium II, III or IV) Ankle Brachial Pulse Index (ABPI) <0,8
- Local infection in the therapy area
- Auto-immunological disorders or vasculitis
- Use of systemic corticosteroids
- Inability to don, doff, and adjust the Juxta-Fit
- If the ankle circumference around the malleoli is greater than 38cm or if the difference between the arch circumference and the circumference around the base of the toes is greater than 7cm.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: trico bandage
Leg lymphedema stage 2-3
|
In general non-elastic bandaging is the compression treatment in lymphedema
Other Names:
|
Experimental: juxta fit compression device
leg lymphedema stage 2/3
|
In general non-elastic bandaging is the compression treatment in lymphedema
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy of a device initial made for the maintenance treatment phase, which is now used in the initial treatment phase during 24 hour
Time Frame: short term study during 26 hours
|
short term study during 26 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Quality of life (Visual Analog Scale) and number of self-management interventions by the patient in the study group
Time Frame: short term study during 26 hours
|
short term study during 26 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: RJ Damstra, MD PhD, Nij Smellinghe Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NS2NL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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