LymphedemaNCT01096589
Assessment of 3M Oedema Reduction System in the Treatment of Lymphoedema Compared to Commercial Short-stretch Bandage
A study testing 3M Coban 2 (Compression System) and Comprilan in people with Lymphedema, run by Solventum US LLC at 11 sites in 2 countries.
Trial summary
Objectives. The primary objective of the study is to assess volume reduction in the treatment of lymphoedematous legs and arms with compression bandaging. Secondary objectives: Assessment of safety Quality of life Health economic parameters Slippage Subbandage pressure Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphedema
- What is being tested?
- 3M Coban 2 (Compression System) and Comprilan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Mar 2010to Oct 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Mobile males or females, age 18 years or older
- Unilateral arm lymphoedema of secondary origin
- Pitting arm lymphoedema diagnosed as stage II or late stage II according to the International Society of Lymphology staging
- Patients who require intense bandaging therapy (approx. >= 15% increase in arm volume over the opposite healthy arm)
- Completion of all primary and adjuvant cancer treatments (surgery, chemotherapy, radiotherapy) at least 6 months prior to randomisation
- Willing to give written informed consent and willing to comply with the study protocol
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- Mobile males or females, age 18 years or older
- Unilateral or bilateral leg lymphoedema of primary or secondary origin
- Pitting leg lymphoedema diagnosed as stage II or late stage II according to the International Society of Lymphology staging
- Patients who require intense bandaging therapy
- Completion of all primary and adjuvant cancer treatments (surgery, chemotherapy, radiotherapy) at least 6 months prior to randomisation
- Willing to give written informed consent and willing to comply with the study protocol
Who cannot join
- Known pregnancy
- Evidence of active cancer, either local or metastatic
- A period of intense daily bandaging within the last month
- Decompensated heart failure or clinically relevant kidney or liver disease
- Known relevant arterial disease of the arms
- Deep vein thrombosis or phlebitis in the last 3 months
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- Paralysis of the arms
- Clinical infection of the arms (e.g. erysipelas)
- Wounds located at the study arm that require dressing change more than once a week
- History of allergic reactions to study material
- Participation in any prospective clinical study that can potentially interfere with this study
- Participants who are, in the opinion of the clinical investigator, unsuitable for enrolment in this study, for reasons not specified in the exclusion criteria.
- Known pregnancy
- Evidence of active cancer, either local or metastatic
- A period of intense daily bandaging within the last month
- Decompensated heart failure or clinically relevant kidney or liver disease
- Deep vein thrombosis or phlebitis in the last 3 months
- Known relevant arterial disease of the legs
- Paralysis of the legs
- Clinical infection of the legs (e.g. erysipelas)
- Circumferential Lymphorrhoea
- Wounds located at the study leg that require dressing change more than once a week
- History of allergic reactions to study material
- Participation in any prospective clinical study that can potentially interfere with this study
- Participants who are, in the opinion of the clinical investigator, unsuitable for enrolment in this study, for reasons not specified in the exclusion criteria.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
United Kingdom7 sites
Kendal Lymphology Centre
Kendal, LA9 4BD
LOROS Hospice
Leicester, LE3 9QE
St Giles Hospice Lymphoedema Service
Lichfield, WS14 9LH
Enfield Macmillan Lymphoedema Service
London, N9 7HD
56 London Road Clinic
Milborne Port, Dorset, DT9 5DW
St Oswalds Hospice Lymphoedema Clinic
Newcastle upon Tyne, NE3 1EE
Swansea Lymphoedema Service Singleton Hospital
Swansea, SA2 8QA
United States4 sites
University of Missouri
Columbia, Missouri, 65203
NorthShore University Healthsystem
Evanston, Illinois, 60201
Memorial Hermann Hyperbaric Center
Houston, Texas, 77030
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Preliminary Study to Assess the Effectiveness of 3M Oedema Reduction System in the Treatment of Lymphoedema Treatment Compared to Comprilan Short-stretch Bandage Compression Therapy
Objectives. The primary objective of the study is to assess volume reduction in the treatment of lymphoedematous legs and arms with compression bandaging.
Secondary objectives:
- Assessment of safety
- Quality of life
- Health economic parameters
- Slippage
- Subbandage pressure
- Conditions
- Lymphedema
- Being tested
- 3M Coban 2 (Compression System), Comprilan
- Keywords
- lymphoedema, lymphedema
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3M Coban 2 (Compression System)Device
Nonwoven cohesive backing and foam.
3M Coban 2 (Compression System)Device
Nonwoven cohesive backing and foam.
3M Coban 2 (Compression System)Device
Nonwoven cohesive backing and foam.
ComprilanDevice
Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - 3M Coban 2 | Experimental | 3M Coban 2 - 2 apps/wk Receives: Device: 3M Coban 2 (Compression System) |
| Arm 2 - 3M Coban 2 | Experimental | 3M Coban 2 - 3 apps/wk Receives: Device: 3M Coban 2 (Compression System) |
| Arm 3 - 3M Coban 2 | Experimental | Arm 3 - 3M Coban 2 - 5 apps/wk Receives: Device: 3M Coban 2 (Compression System) |
| Arm 4 - Comprilan | Active comparator | Comprilan short-stretch bandage 5 apps/wk Receives: Device: Comprilan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline.
Measured: baseline and after 3 weeks of treatment
Secondary outcomes (1)
Assessment of Safety by Incidence of Adverse Events.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solventum US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Christine Moffatt, Prof., Principal investigator, Faculty of Medicine, Division of Nursing and Healthcare, Universtity of Glasgow, G12 8LW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01096589
- Sponsor's protocol ID
- EU Study-05-000012
- Status last verified
- Sep 2024
- First submitted
- 22 Mar 2010
- Last updated
- 2 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Study to Assess the Effectiveness of 3M Oedema Reduction System in the Treatment of Lymphoedema Treatment Compared to Comprilan Short-stretch Bandage Compression Therapy
- ClinicalTrials.gov ID
- NCT01096589
- Acronym / sponsor ID
- EU Study-05-000012
- Conditions
- Lymphedema
- Keywords
- lymphoedema, lymphedema
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Solventum US LLCIndustry (pharma, biotech, devices)
- Collaborators
- 3M
- Study start
- Mar 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 31 Mar 2010 (estimated)
- Results
- Posted 27 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives. The primary objective of the study is to assess volume reduction in the treatment of lymphoedematous legs and arms with compression bandaging.
Secondary objectives:
- Assessment of safety
- Quality of life
- Health economic parameters
- Slippage
- Subbandage pressure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - 3M Coban 2 | Experimental | Device: 3M Coban 2 (Compression System)3M Coban 2 - 2 apps/wk |
| Arm 2 - 3M Coban 2 | Experimental | Device: 3M Coban 2 (Compression System)3M Coban 2 - 3 apps/wk |
| Arm 3 - 3M Coban 2 | Experimental | Device: 3M Coban 2 (Compression System)Arm 3 - 3M Coban 2 - 5 apps/wk |
| Arm 4 - Comprilan | Active comparator | Device: ComprilanComprilan short-stretch bandage 5 apps/wk |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Mobile males or females, age 18 years or older
- Unilateral arm lymphoedema of secondary origin
- Pitting arm lymphoedema diagnosed as stage II or late stage II according to the International Society of Lymphology staging
- Patients who require intense bandaging therapy (approx. >= 15% increase in arm volume over the opposite healthy arm)
- Completion of all primary and adjuvant cancer treatments (surgery, chemotherapy, radiotherapy) at least 6 months prior to randomisation
Key exclusion criteria (25 listed)
- Known pregnancy
- Evidence of active cancer, either local or metastatic
- A period of intense daily bandaging within the last month
- Decompensated heart failure or clinically relevant kidney or liver disease
- Known relevant arterial disease of the arms
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 |
|---|---|---|
| 3M Coban 2 (Compression System)Nonwoven cohesive backing and foam. | Device | Arm 1 - 3M Coban 2 |
| 3M Coban 2 (Compression System)Nonwoven cohesive backing and foam. | Device | Arm 2 - 3M Coban 2 |
| 3M Coban 2 (Compression System)Nonwoven cohesive backing and foam. | Device | Arm 3 - 3M Coban 2 |
| ComprilanCommercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K). | Device | Arm 4 - Comprilan |
Primary outcome
Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline.
Time frame: baseline and after 3 weeks of treatment
1 secondary outcome
Assessment of Safety by Incidence of Adverse Events.
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Christine Moffatt, Prof. principal investigator
Faculty of Medicine, Division of Nursing and Healthcare, Universtity of Glasgow, G12 8LW
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3M Coban 2 (Compression System) and Comprilan in people with Lymphedema, run by Solventum US LLC at 11 sites in 2 countries.
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 12 inclusion and 25 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 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United Kingdom, United States. 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?
Yes. Results are posted in the registry (first posted 27 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Volume Change of Affected Limb at End of Treatment Compared to Baseline. (time frame: baseline and after 3 weeks of treatment). 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 2 Oct 2024.