Leg UlcersPhase 2NCT00821431
Compression Device Versus 4-layer Compression System
A Phase 2 study testing Compression Device and Profore in people with Leg Ulcers, run by ConvaTec Inc. at 20 sites in 4 countries.
Trial summary
A prospective, Phase II, stratified, randomized study to compare the safety, ulcer healing, patient compliance (concordance) and resource utilisation of a compression device with IPC mode to a Class 3(c) UK standard graduated compression regime (4- layer system) on subjects with venous leg ulcers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leg Ulcers
- What is being tested?
- Compression Device and Profore
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 20 sitesin 4 countries
- Study dates
- May 2006to Jun 2008
- Phase
- Phase 2
- 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
- Subjects over 18 years, willing and able to provide written informed consent
- Subjects able to wear the compression device and the comparative regime and follow the requirements of the clinical investigation plan
- Subjects who had an ankle to brachial pressure index (ABPI) of 0.8 or greater
- Subjects who had a chronic venous leg ulcer (i.e. CEAP classification of C6 1) 2 cm2 in size or greater, who required graduated compression
- Subjects who were outpatients
Who cannot join
- Subjects with a history of skin sensitivity to any of the components of the study product, comparator product or standard dressings
- *Subjects with more than one ulcer on the test leg
- Subjects who had previously been entered into the study or a previous Amadeus study (U327, U332 or U337) or had participated in a previous clinical study within the past 3 months
- Subjects with any condition that prevented application and removal of the device without external assistance
- Subjects who had an active Deep Vein Thrombosis (DVT) or a recent DVT within the last 3 months
- Subjects who exhibited any other medical condition which, according to the Investigator, justified the subject's exclusion from the study
Show all 19Show fewer
- Subjects who had leg sizes outside the following range:
- Ankle - 12cm to 44cm
- Calf - 22cm to 60cm
- Below knee - 22cm to 68cm
- Subjects who had an index venous leg ulcer greater in size than 10cm in any one dimension
- Diabetic subjects with advanced small vessel disease
- Denotes the exclusion criterion was amended and approved by the Ethics Committees as follows:
- Amendment #1 dated 27th March 2007:
- Diabetic subjects who, in the opinion of the investigator, were not in reasonable metabolic control or had a history of hospitalisation within the last six months for the management of blood sugar and/or diabetic subjects with advanced small vessel disease
- Amendment #2 dated 2nd August 2007:
- Subjects who had an index venous leg ulcer greater in size than 15cm in any one dimension
- Amendment #3 dated 5th October 2007:
- Deletion of exclusion criterion 'Subjects with more than one ulcer on the test leg' to permit inclusion of subjects with multiple ulcers on the test leg
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
United Kingdom12 sites
Dermatology Day Unit; Monklands Hospital
Airdrie
The Wilson Practice, Alton Health Centre
Alton
Wound Healing Research Unit; Cardiff University
Cardiff
Tissue Viability Consultancy
Eastbourne
Institute of Wound Care, The University of Hull
Hull
Diving Diseases Research Centre, Hyperbaric Medical Centre
Plymouth
University Dept of Vascular
Solihull
Medical Physics & Bioengineering, Southampton University Hospital
Southampton
Department of Vascular Surgery, Good Hope Hospital
Sutton Coldfield
Trowbridge Community Hospital
Trowbridge
Arrowe Park Hospital
Upton
Short Health Clinic
Willenhall
Germany3 sites
Hautarzt Phlebologe Allergologe
Freiburg im Breisgau
Private Practice
Gilching
Private Practice
Hamburg
Ireland3 sites
The Adelaide & Meath Hospital
Dublin
Mid-Western Regional Hospital
Limerick
Cork University Hospital
Wilton
France2 sites
Private Practice
Neuilly-sur-Seine
Groupe Hospitalier Saint-Joseph
Paris
About this study
Official title: A Phase II Study to Compare the Effect of a Compression Device to That of a 4-layer Compression System on Subjects With Venous Leg Ulcers.
A prospective, Phase II, stratified, randomized study to compare the safety, ulcer healing, patient compliance (concordance) and resource utilisation of a compression device with IPC mode to a Class 3(c) UK standard graduated compression regime (4- layer system) on subjects with venous leg ulcers.
- Conditions
- Leg Ulcers
- Being tested
- Compression Device, Profore
- Medical subject headings
- Leg Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compression DeviceDevice
Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:
Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.
Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day.
ProforeDevice
Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert.
| Study group | Role | What they receive |
|---|---|---|
| Compression device | Experimental | The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf. Receives: Device: Compression Device |
| Profore, 4-layer bandage | Active comparator | A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer. Receives: Device: Profore |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Measured by the Number of Subjects With Adverse Events (Including Any Deterioration of Ulcer)
Measured: 12 Weeks
Secondary outcomes (1)
Healing Measured by Number of Subjects Healed During the 12 Week Study Period
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startMay 2006
- Primary completionJun 2008
- Study completionJun 2008
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 Leg UlcersStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathon Hopper, MD, Study director, ConvaTec Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821431
- Sponsor's protocol ID
- CW-0500-05-U342
- Status last verified
- Jan 2015
- First submitted
- 9 Jan 2009
- Last updated
- 9 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Compare the Effect of a Compression Device to That of a 4-layer Compression System on Subjects With Venous Leg Ulcers.
- ClinicalTrials.gov ID
- NCT00821431
- Acronym / sponsor ID
- CW-0500-05-U342
- Conditions
- Leg Ulcers
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 13 Jan 2009 (estimated)
- Results
- Posted 9 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, Phase II, stratified, randomized study to compare the safety, ulcer healing, patient compliance (concordance) and resource utilisation of a compression device with IPC mode to a Class 3(c) UK standard graduated compression regime (4- layer system) on subjects with venous leg ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compression device | Experimental | Device: Compression DeviceThe electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf. |
| Profore, 4-layer bandage | Active comparator | Device: ProforeA high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subjects over 18 years, willing and able to provide written informed consent
- Subjects able to wear the compression device and the comparative regime and follow the requirements of the clinical investigation plan
- Subjects who had an ankle to brachial pressure index (ABPI) of 0.8 or greater
- Subjects who had a chronic venous leg ulcer (i.e. CEAP classification of C6 1) 2 cm2 in size or greater, who required graduated compression
- Subjects who were outpatients
Key exclusion criteria (19 listed)
- Subjects with a history of skin sensitivity to any of the components of the study product, comparator product or standard dressings
- *Subjects with more than one ulcer on the test leg
- Subjects who had previously been entered into the study or a previous Amadeus study (U327, U332 or U337) or had participated in a previous clinical study within the past 3 months
- Subjects with any condition that prevented application and removal of the device without external assistance
- Subjects who had an active Deep Vein Thrombosis (DVT) or a recent DVT within the last 3 months
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 |
|---|---|---|
| Compression DeviceSubjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures: Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg. Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day. | Device | Compression device |
| ProforeSubjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert. | Device | Profore, 4-layer bandage |
Primary outcome
Safety Measured by the Number of Subjects With Adverse Events (Including Any Deterioration of Ulcer)
Time frame: 12 Weeks
1 secondary outcome
Healing Measured by Number of Subjects Healed During the 12 Week Study Period
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
- 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.
Jonathon Hopper, MD study director
ConvaTec Inc.
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Compression Device and Profore in people with Leg Ulcers, run by ConvaTec Inc. at 20 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 5 inclusion and 19 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 9 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United Kingdom, Germany, Ireland, France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2015). 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?
Safety Measured by the Number of Subjects With Adverse Events (Including Any Deterioration of Ulcer) (time frame: 12 Weeks). 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 9 Jan 2015.