Venous UlcerNCT00558662

Randomized Clinical Trial (RCT) to Compare the Efficacy of Coban 2 Versus SSB in the Treatment of Venous Leg Ulcers

A study testing Coban 2 and SSB in people with Venous Ulcer, run by Solventum US LLC at 16 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The study purpose is to compare healing rates, cost effectiveness, quality of life and safety of 12 week compression therapy for the treatment of venous leg ulcers with the 3M™ Coban™ 2 Layer Compression System versus short-stretch compression bandage. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Venous Ulcer
What is being tested?: Coban 2 and SSB
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 234 participants
Where: 16 sitesin 4 countries
Study dates: Nov 2007to Sep 2011
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

Males or females, age 18 years or older
Subjects having a venous leg ulcer (stage C6 according CEAP classification, venous pathology proved by the presence of reflux (Pr)), which is at least 1 cm in any dimension but not larger than 10 cm in any dimension and has at least 5 cm distance to additional ulcers.
Subjects who are co-operative, willing to give written informed consent prior to study entry, and willing to comply with the study protocol.
Subjects who are able to understand and answer questionnaire items.
Subjects who can walk (with or without a walking aid).
Subjects who have an ABPI (ankle brachial pressure index) of treated leg greater or equal to 0,8 as measured within four weeks prior to enrollment.
Subjects with venous incompetence as defined by reflux longer than 1,0 second in at least one of the following sites: groin [femoral vein, junction of GSV], mid thigh medial [GSV], hollow of the knee [popliteal vein, junction of SSV], mid calf [SSV] in the standing position, measured by Doppler, preferably by duplex within the last 12 month without following active treatment of venous reflux.

Who cannot join

Subjects with an ABPI < 0.8 as measured within four weeks prior to enrollment.
Subjects whose condition, in the opinion of the investigator, does not require or allow for compression therapy.
Subjects where the potential study ulcer is infected, i.e. showing signs of clinical infection (not contamination) as evidenced by purulent, malodorous, or recent increase in drainage and/or peri-wound erythema or elevated temperature.
Subjects receiving any systemic antibiotics.
Subjects with diagnosed cancerous ulceration.
Subjects with diabetic foot ulcers (do not exclude diabetics).

Show all 11Show fewer

Subjects with circumferential wounds.
Subjects who started or significantly changed treatment with mood altering substances (e.g. antidepressant drugs) within two weeks prior to enrollment.
Subjects who are participating in any prospective clinical study that can potentially interfere with this study.
Subjects who are, in the opinion of the clinical investigator, unsuitable for enrollment in this study, for reasons not specified in the exclusion criteria.
Subjects with known allergies against the following products: Coban 2 Layer Compression System, Rosidal K, Rosidal soft, Tegaderm Foam, Cavilon NSBF

Trial locations and contacts

16 sites in 4 countries.

Country

City, postcode or hospital

16 sites in 4 countries

Germany6 sites

Klinik für Dermatologie der Rhr Universität Bochum - Venenzentrum der dermatologischen und gefäßchirurgischen Kliniken
Bochum, 44805
Klinik und Poliklinik für Dermatologie der Universität Bonn
Bonn, 53105
Universitätsklinikum Essen, Klinik und Poliklinik für Dermatologie, Venerologie und Allergologie
Essen, 45147
Prof. Vanscheidt, MD, PhD
Freiburg im Breisgau, 79102
Klinikum Lippe_lemgo
Lemgo, 32657
Kliniken Maria Hilf
Mönchengladbach, 41069

Other trials in Germany

Netherlands4 sites

Ziekenhuis de Lievensberg, Department of Dermatology
Bergen op Zoom, 4600AC
IJsselland Hospital
Capelle aan den IJssel, 2906
Atrium Medisch Centrum Parkstad in Heerlen
Heerlen, 6419
Dr. Kolbach Kliniek
Maastricht, 6218

Other trials in Netherlands

Belgium3 sites

Military Hospital Queen Astrid
Brussels, Neder-Over-Heembeek, 1120
AZ Alma Eeklo
Eeklo, Moeie 13, 9900
Wound Centre AZ St. Elisabeth
Zottegem, Godveerdegemstraat 69, 9620

Other trials in Belgium

United Kingdom3 sites

Wound Healing Research unit, Cardiff Medicentre
Cardiff, CF14 4UJ
Tissue Viability
Eastbourne, BN21 4RL
Trowbridge Community Hospital
Trowbridge

Other trials in United Kingdom

About this study

Official title: Randomized Controlled Clinical Study to Assess the Clinical Efficacy of the 3M™ Coban™ 2 Layer Compression System Compared to a Short-stretch Compression Bandage in the Treatment of Venous Leg Ulcers

Conditions: Venous Ulcer
Being tested: Coban 2, SSB
Keywords: compression therapy, venous leg ulcer, sub bandage pressure
Medical subject headings: Varicose Ulcer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Coban 2Device
Also called Coban 2 Layer Compression System
Bandages will be changed after a wear time of seven days, or in case of product or non-product related reason, which would require a dressing or bandage change.
SSBDevice
Also called Rosidal K, Rosidal soft
Bandages will be changed after a wear time of seven days, or in case of product or non-product related reason, which would require a dressing or bandage change.

Study groups in NCT00558662
Study group	Role	What they receive
1	Active comparator	Coban 2 Layer Compression System Receives: Device: Coban 2
2	Active comparator	Short-Stretch Bandage Receives: Device: SSB

What is being measured

The primary outcome is the main question the study is designed to answer.

- venous leg ulcer healing
Measured: 12 weeks

Secondary outcomes (1)

- wound size reduction - HRQoL - treatment-cost based on material consumption and visit costs - sub-bandage pressure measurements - AE/SAE
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007Sep 2011

First posted15 Nov 2007 (estimated)
Study startNov 2007
Primary completionApr 2009
Study completionSep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Venous UlcerStudies 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 234 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00558662
Sponsor's protocol ID: EU Study No-05-000003
Status last verified: Sep 2024
First submitted: 13 Nov 2007
Last updated: 2 Oct 2024
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
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Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
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All Venous Ulcer trials

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: Randomized Controlled Clinical Study to Assess the Clinical Efficacy of the 3M™ Coban™ 2 Layer Compression System Compared to a Short-stretch Compression Bandage in the Treatment of Venous Leg Ulcers
ClinicalTrials.gov ID: NCT00558662
Acronym / sponsor ID: EU Study No-05-000003
Conditions: Venous Ulcer
Keywords: compression therapy, venous leg ulcer, sub bandage pressure
Study type: Interventional
Recruitment status: Completed
Enrolment: 234 participants (actual)
Lead sponsor: Solventum US LLCIndustry (pharma, biotech, devices)
Collaborators: 3M
Study start: Nov 2007
Primary completion: Apr 2009 (actual)
Study completion: Sep 2011 (actual)
First posted: 15 Nov 2007 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Device: Coban 2Coban 2 Layer Compression System
2	Active comparator	Device: SSBShort-Stretch Bandage

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Males or females, age 18 years or older
Subjects having a venous leg ulcer (stage C6 according CEAP classification, venous pathology proved by the presence of reflux (Pr)), which is at least 1 cm in any dimension but not larger than 10 cm in any dimension and has at least 5 cm distance to additional ulcers.
Subjects who are co-operative, willing to give written informed consent prior to study entry, and willing to comply with the study protocol.
Subjects who are able to understand and answer questionnaire items.
Subjects who can walk (with or without a walking aid).

Key exclusion criteria (11 listed)

Subjects with an ABPI < 0.8 as measured within four weeks prior to enrollment.
Subjects whose condition, in the opinion of the investigator, does not require or allow for compression therapy.
Subjects where the potential study ulcer is infected, i.e. showing signs of clinical infection (not contamination) as evidenced by purulent, malodorous, or recent increase in drainage and/or peri-wound erythema or elevated temperature.
Subjects receiving any systemic antibiotics.
Subjects with diagnosed cancerous ulceration.

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
Coban 2Also: Coban 2 Layer Compression SystemBandages will be changed after a wear time of seven days, or in case of product or non-product related reason, which would require a dressing or bandage change.	Device	1
SSBAlso: Rosidal K, Rosidal softBandages will be changed after a wear time of seven days, or in case of product or non-product related reason, which would require a dressing or bandage change.	Device	2

Primary outcome

- venous leg ulcer healing
Time frame: 12 weeks

1 secondary outcome

- wound size reduction - HRQoL - treatment-cost based on material consumption and visit costs - sub-bandage pressure measurements - AE/SAE
Time frame: 12 weeks

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 2 Oct 2024.

Related trials for Venous Ulcer

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Recruiting
Vacuum Compression Therapy and Tissue Oxygenation in Chronic Leg Ulcers
Leg Ulcers, Leg Ulcers Venous
Recruiting
Dose-Response Structured Calf Muscle Pump Activation Strategies Versus Unsupervised Home Walks
Venous Ulcer of Leg
RecruitingPhase 4
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Leg Ulcer

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.

Wolfgang Vanscheidt, Prof MD PhD study chair

Eberhard Rabe, Prof. MD PhD principal investigator

Klnik und Poliklinik für Dermatologie der Universität Bonn

Joachim Dissemond, MD PhD principal investigator

Universitätsklinik Essen

16 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Coban 2 and SSB in people with Venous Ulcer, run by Solventum US LLC at 16 sites in 4 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 7 inclusion and 11 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 16 sites in Germany, Netherlands, Belgium, United Kingdom. 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?

- venous leg ulcer healing (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00558662.

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.