Leg LymphedemaNCT00665379
Comparative Trial in Compression Therapy in Leg Lymphedema
A study testing Regular Compression therapy (Trico bandages) and New Compression therapy (C2L bandages) in people with Leg Lymphedema, run by Nij Smellinghe Hosptial at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leg Lymphedema
- What is being tested?
- Regular Compression therapy (Trico bandages) and New Compression therapy (C2L bandages)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2008to May 2009
- Phase
- Interventional
- 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
- The patient is able to understand the study and is willing to give written informed consent to the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Nij Smellinghe hospital
Drachten, Provincie Friesland, 9202NN
About this study
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.
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.
Read the 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
- Conditions
- Leg Lymphedema
- Being tested
- Regular Compression therapy (Trico bandages), New Compression therapy (C2L bandages)
- Keywords
- leg lymphedema, volume measurement, compression therapy, interface pressure, static stiffness index (SSI), volume change
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular Compression therapy (Trico bandages)Other
Also called 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)Other
Also called coban 2
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Regular compression therapy with non elastic trico bandaging Receives: Other: Regular Compression therapy (Trico bandages) |
| 2 | Active comparator | New two layer compression bandage coban 2 Receives: Other: New Compression therapy (C2L bandages) |
What is being measured
The primary outcome is the main question the study is designed to answer.
volume decrease in relation to interface pressure after application of two types of bandages.
Measured: enrollment of 30 patients
Secondary outcomes (1)
Pressure drop after 2 hours and 24 hours of bandaging
Measured: after application, at 2 hours and 24 hours after application of bandage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionApr 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leg 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 N/A
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- 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, Principal investigator, Nij Smellinghe HospitalH Partsch, PhD, Study director, Private practice, wien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00665379
- Sponsor's protocol ID
- NS1NL
- Status last verified
- May 2012
- First submitted
- 17 Apr 2008
- Last updated
- 22 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00665379
- Acronym / sponsor ID
- NS1NL
- Conditions
- Leg Lymphedema
- Keywords
- leg lymphedema, volume measurement, compression therapy, interface pressure, static stiffness index (SSI), volume change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nij Smellinghe HosptialUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 23 Apr 2008 (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.
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
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Regular Compression therapy (Trico bandages)Regular compression therapy with non elastic trico bandaging |
| 2 | Active comparator | Other: New Compression therapy (C2L bandages)New two layer compression bandage coban 2 |
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
- The patient is able to understand the study and is willing to give written informed consent to the study
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Regular Compression therapy (Trico bandages)Also: trico bandagesApplication 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 | Other | 1 |
| New Compression therapy (C2L bandages)Also: coban 2Application 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 | Other | 2 |
Primary outcome
volume decrease in relation to interface pressure after application of two types of bandages.
Time frame: enrollment of 30 patients
1 secondary outcome
Pressure drop after 2 hours and 24 hours of bandaging
Time frame: after application, at 2 hours and 24 hours after application of bandage
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 22 May 2012.
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Extracorporeal Shock Wave Therapy in Lower Extremity Lymphedema
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Evaluate Advanced Pneumatic Compression Device With Revised Compression Programming for Lymphedema Treatment
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Aerobic Exercise Effects in Lower Extremity Lymphedema
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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 principal investigator
Nij Smellinghe Hospital
H Partsch, PhD study director
Private practice, wien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regular Compression therapy (Trico bandages) and New Compression therapy (C2L bandages) in people with Leg 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 8 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 22 May 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.
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?
volume decrease in relation to interface pressure after application of two types of bandages. (time frame: enrollment of 30 patients). 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 22 May 2012.