WoundsPhase 2NCT00618787
Prospective Randomized Double Blind Clinical Trial of Polyhexamethylene Biguanide Impregnated Foam Dressing
A Phase 2 study testing COPA AMD (note: name is not an acronym) and COPA (note: name is not an acronym) in people with Wounds, run by Tyco Healthcare Group at 2 sites in Canada.
Trial summary
This is a multi-center, prospective, randomized, double blind, pilot clinical trial of subjects with chronic wounds. The purpose of this study is to compare the efficacy of COPA AMD PHMB Impregnated foam dressing compared to regular foam dressing in subjects with chronic wounds. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Wounds
- What is being tested?
- COPA AMD (note: name is not an acronym) and COPA (note: name is not an acronym)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesCanada
- Study dates
- Feb 2008to Apr 2009
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subject is 18 to 85 years of age inclusive
- subject has a foot ulcer
- subject has a leg ulcer
- subject has an open wound of at 1.0 cm (2)
- subject has one of the following: Palpable pulse, ABI > 0.56 or toe pressure > 50 mmHg
- subject or legally authorized rep is able to understand and willing to give written informed consent
Who cannot join
- subject has an allergy to Chlorhexidine Gluconate (CHG)
- subject has open wounds that in the opinion of the Principal Investigator do not have the ability to heal
- subject has current malignant disease or history of malignant disease in past 5 years
- subject has inability to comply with the study protocol and procedures
- subjects who require use of topical agents other than the impregnated or regular foam dressings dressings
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Community Dermatology and Wound Healing Clinic
Mississauga, Ontario, L4Y 1A6
Women's College Hospital; Dermatology Daycare & Wound Healing Clinic
Toronto, Ontario, M5S 1B2
About this study
This is a multi-center, prospective, randomized, double blind, pilot clinical trial of subjects with chronic wounds. The purpose of this study is to compare the efficacy of COPA AMD PHMB Impregnated foam dressing compared to regular foam dressing in subjects with chronic wounds.
- Conditions
- Wounds
- Being tested
- COPA AMD (note: name is not an acronym), COPA (note: name is not an acronym)
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COPA AMD (note: name is not an acronym)Device
Foam dressing impregnated with Polyhexamethylene Biguanide
COPA (note: name is not an acronym)Device
Regular foam dressing without PHMB
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | Not described Receives: Device: COPA AMD (note: name is not an acronym) |
| Arm 2 | Active comparator | Not described Receives: Device: COPA (note: name is not an acronym) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Signs of Critical Colonization, Deep Infection, and Wound Healing Between the Two Groups
Measured: 5 weeks
Percentage Change in Wound Surface Area (cm2) at Week 4 Compared to Week 0.
At each study visit, the subject's wound surface area was measured by longest length times widest width at right angles (LxW=cm2). Compiled data were analyzed to determine the median percentage decrease in wound surface area between groups and between study visits. Results report the median percentage decrease of the wound surface area as measured by cm2, comparing wound surface area at Week 4 to Week 0.
Measured: Weeks 0 and 4
Secondary outcomes (1)
Pain
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionApr 2009
- Study completionApr 2009
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 WoundsStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tyco Healthcare Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- R. Gary Sibbald, MD, Principal investigator, Community Dermatology and Wound Healing Clinic, Women's College Hospital- Dermatology Daycare & Wound Healing Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618787
- Sponsor's protocol ID
- 360.18
- Status last verified
- Apr 2010
- First submitted
- 10 Jan 2008
- Last updated
- 15 Apr 2010
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Double Blind Clinical Trial of Polyhexamethylene Biguanide Impregnated Foam Dressing
- ClinicalTrials.gov ID
- NCT00618787
- Acronym / sponsor ID
- 360.18
- Conditions
- Wounds
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Tyco Healthcare GroupIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 20 Feb 2008 (estimated)
- Results
- Posted 7 Apr 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, prospective, randomized, double blind, pilot clinical trial of subjects with chronic wounds. The purpose of this study is to compare the efficacy of COPA AMD PHMB Impregnated foam dressing compared to regular foam dressing in subjects with chronic wounds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Device: COPA AMD (note: name is not an acronym) |
| Arm 2 | Active comparator | Device: COPA (note: name is not an acronym) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- subject is 18 to 85 years of age inclusive
- subject has a foot ulcer
- subject has a leg ulcer
- subject has an open wound of at 1.0 cm (2)
- subject has one of the following: Palpable pulse, ABI > 0.56 or toe pressure > 50 mmHg
Key exclusion criteria (5 listed)
- subject has an allergy to Chlorhexidine Gluconate (CHG)
- subject has open wounds that in the opinion of the Principal Investigator do not have the ability to heal
- subject has current malignant disease or history of malignant disease in past 5 years
- subject has inability to comply with the study protocol and procedures
- subjects who require use of topical agents other than the impregnated or regular foam dressings dressings
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 |
|---|---|---|
| COPA AMD (note: name is not an acronym)Foam dressing impregnated with Polyhexamethylene Biguanide | Device | Arm 1 |
| COPA (note: name is not an acronym)Regular foam dressing without PHMB | Device | Arm 2 |
Primary outcome
Prevalence of Signs of Critical Colonization, Deep Infection, and Wound Healing Between the Two Groups
Time frame: 5 weeks
Percentage Change in Wound Surface Area (cm2) at Week 4 Compared to Week 0.
Time frame: Weeks 0 and 4
At each study visit, the subject's wound surface area was measured by longest length times widest width at right angles (LxW=cm2). Compiled data were analyzed to determine the median percentage decrease in wound surface area between groups and between study visits. Results report the median percentage decrease of the wound surface area as measured by cm2, comparing wound surface area at Week 4 to Week 0.
1 secondary outcome
Pain
Time frame: 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2010.
- 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.
R. Gary Sibbald, MD principal investigator
Community Dermatology and Wound Healing Clinic, Women's College Hospital- Dermatology Daycare & Wound Healing Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing COPA AMD (note: name is not an acronym) and COPA (note: name is not an acronym) in people with Wounds, run by Tyco Healthcare Group at 2 sites in Canada.
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 6 inclusion and 5 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 15 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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 7 Apr 2010). 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?
Prevalence of Signs of Critical Colonization, Deep Infection, and Wound Healing Between the Two Groups (time frame: 5 weeks). The study lists 2 primary outcomes in all. 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 15 Apr 2010.