LymphedemaPhase 4NCT01068431
Short Term Effectiveness Study of Juxta-Fit Versus Trico Bandages in the Treatment of Leg Lymphedema
A Phase 4 study of Lymphedema, run by Nij Smellinghe Hosptial at 1 site in Netherlands.
Trial summary
Juxta-Fit is used for compression treatment. Juxta-Fit is an inelastic compression device which can be easily adjusted to the circumference of the limb and is usually used during the maintenance phase of lymphedema treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Feb 2010to Aug 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Nij Smellinghe hospital
Drachten, Provincie Friesland, 9200 DA
About this study
Official title: Prospective, Randomized Controlled Trial Comparing the Effect of CircAid(R) Juxta-Fit(tm) Versus Trico Bandages in the Treatment of Leg Lymphedema
Juxta-Fit is used for compression treatment. Juxta-Fit is an inelastic compression device which can be easily adjusted to the circumference of the limb and is usually used during the maintenance phase of lymphedema treatment. The aim of the study is to assess the effectiveness of Juxta-Fit in the initial treatment phase of leg lymphedema compared to the traditional treatment with Trico bandages in relation to interface pressure and to explore if self-management by Juxta fit is efficient after a short demonstration. Data are collected at 0-2-24 hours
Read the 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.
- Conditions
- Lymphedema
- Being tested
- bandaging with trico as active controller
- Keywords
- lymphedema, conservative treatment, compression therapy, interface pressure
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bandaging with trico as active controllerOther
Also called Trico bandages (BSNmedical)
In general non-elastic bandaging is the compression treatment in lymphedema
| Study group | Role | What they receive |
|---|---|---|
| trico bandage | Active comparator | Leg lymphedema stage 2-3 Receives: Other: bandaging with trico as active controller |
| juxta fit compression device | Experimental | leg lymphedema stage 2/3 Receives: Other: bandaging with trico as active controller |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of a device initial made for the maintenance treatment phase, which is now used in the initial treatment phase during 24 hour
Measured: short term study during 26 hours
Secondary outcomes (1)
Quality of life (Visual Analog Scale) and number of self-management interventions by the patient in the study group
Measured: short term study during 26 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nij Smellinghe Hosptial
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, R.J. Damstra, Nij Smellinghe Hosptial
- Investigators
- RJ Damstra, MD PhD, Principal investigator, Nij Smellinghe Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068431
- Sponsor's protocol ID
- NS2NL
- Status last verified
- Dec 2012
- First submitted
- 3 Feb 2010
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Controlled Trial Comparing the Effect of CircAid(R) Juxta-Fit(tm) Versus Trico Bandages in the Treatment of Leg Lymphedema
- ClinicalTrials.gov ID
- NCT01068431
- Acronym / sponsor ID
- NS2NL
- Conditions
- Lymphedema
- Keywords
- lymphedema, conservative treatment, compression therapy, interface pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nij Smellinghe HosptialUniversity, hospital or other
- Study start
- Feb 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 15 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Juxta-Fit is used for compression treatment. Juxta-Fit is an inelastic compression device which can be easily adjusted to the circumference of the limb and is usually used during the maintenance phase of lymphedema treatment. The aim of the study is to assess the effectiveness of Juxta-Fit in the initial treatment phase of leg lymphedema compared to the traditional treatment with Trico bandages in relation to interface pressure and to explore if self-management by Juxta fit is efficient after a short demonstration. Data are collected at 0-2-24 hours
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trico bandage | Active comparator | Other: bandaging with trico as active controllerLeg lymphedema stage 2-3 |
| juxta fit compression device | Experimental | Other: bandaging with trico as active controllerleg lymphedema stage 2/3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bandaging with trico as active controllerAlso: Trico bandages (BSNmedical)In general non-elastic bandaging is the compression treatment in lymphedema | Other | juxta fit compression device, trico bandage |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2012.
Related trials for Lymphedema
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
RJ Damstra, MD PhD principal investigator
Nij Smellinghe Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Lymphedema, run by Nij Smellinghe Hosptial at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2012.