Venous UlcerPhase 2NCT00202267
Community RCT of the Effectiveness of Two Compression Bandaging Technologies
A Phase 2 study testing Four-layer Bandage (Elastomeric) and Short-stretch Bandage (Non-elastomeric) in people with Venous Ulcer, run by Queen's University at 15 sites in Canada.
Trial summary
Leg ulcers are emotionally distressing and painful, and often require months or years to heal. Although rarely acknowledged as a pressing health care issue, leg ulcers comprise a common, complex, and costly condition, managed primarily through community home care services. 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?
- Four-layer Bandage (Elastomeric) and Short-stretch Bandage (Non-elastomeric)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 426 participants
- Where
- 15 sitesCanada
- Study dates
- Jan 2004to Dec 2008
- Phase
- Phase 2
- 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
- clinical presentation of venous insufficiency
- leg ulcer equal to or larger than 0.7 cm in any one dimension
- ulcer a minimum duration of 1 week
- ankle brachial pressure index equal to or greater than 0.80
- participant can provide written consent
- participant can communicate in English, or translation available
- participant 18 years or over
Who cannot join
- diagnosed with Diabetes Mellitus - insulin dependent or participant on oral hypoglycemics
- participants who failed to improve over a 3-month period after being treated with either the SS or 4-layer compression bandaging system prior to the trial
- previous trial patients (ie individuals previously enrolled in the study but now have recurrence or a new ulcer)
- symptoms of cognitive impairment noted
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Canada15 sites
Nursing Practice Solutions
Fort Erie, Ontario, L2A 2G4
VON Hamilton Branch
Hamilton, Ontario, L8L 5G8
Saint Elizabeth Health Care
Kingston, Ontario, K7L 1G8
Kingston Chronic Wound Clinic
Kingston, Ontario, K7L 5E4
ParaMed Health Services
Kingston, Ontario, K7M 8R1
ET Now
Kitchener, Ontario, N2H 3K5
Carefor
Ottawa, Ontario, K1K 3B8
ParaMed Health Services
Ottawa, Ontario, K1Z 6X3
Ostomy and Wound Care Centre
Regina, Saskatchewan, S4S 0S4
Saskatoon Health Region Home Care
Saskatoon, Saskatchewan, S7H 4W3
St. Joseph's Care Group
Thunder Bay, Ontario, P7B 5G7
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
ParaMed Home Health Care
Toronto, Ontario, M5G 1V2
Comcare Health
Toronto, Ontario, M5S 2T9
Winnipeg Regional Health Authority
Winnipeg, Manitoba, R3G 0N6
About this study
Official title: Community Randomised Control Trial of the Effectiveness of Two Compression Bandaging Technologies
Leg ulcers are emotionally distressing and painful, and often require months or years to heal. Although rarely acknowledged as a pressing health care issue, leg ulcers comprise a common, complex, and costly condition, managed primarily through community home care services. Indeed, leg ulcers are the most frequently seen and treated chronic wound. There is consensus in recent international, evidence-based practice guidelines that graduated, multi-layer compression is the most effective treatment, and greatly reduces healing time. High compression is more effective than low compression. However, there is no clear evidence as to which high compression technology is the most effective in promoting healing, the most acceptable to patients, or the most cost-effective to the health care system. This study is designed to answer these questions through a randomized trial conducted in the community, where most leg ulcer care currently takes place. Issues such as effectiveness in healing, quality of life, physical discomfort, personal preference, cost to the system and to the individual will be taken into consideration in evaluating two most commonly used types of compression bandaging.
Read the detailed description
Background:
Although rarely recognized as a pressing health care problem, leg ulcers comprise a common, complex, and costly condition. Over 80% of ongoing management of chronic wounds occurs in the community, and leg ulcers are one of the most frequently seen chronic wounds. The cost of leg ulcer care is considerable, being reported in both the UK and France to account for 2% of their total national health budgets. In Canada, the impact is only now being recognized due to the pressure on home care caseloads resulting from hospital downsizing, nursing shortages, and growing numbers of complex health populations. In one Ontario study, the care for fewer than 200 community leg ulcer cases cost in excess of $1.5 million for supplies and nursing visits, which translates to $100s of millions yearly Canada-wide. The impact on the individual is significant--chronic, painful, and often takes years to heal. Two-thirds of individuals with leg ulcers have at least one recurrence, and 45% have a history with the condition dating back 10 years.
State of Knowledge \& Clinical Practice Guidelines:
Over the past decade, evidence from RCT studies and a recent Cochrane systematic review in BMJ demonstrated that venous leg ulcers treated with compression therapy are more likely to heal. Multi-layer high compression systems are more effective than low compression. However, the small number of people in trials comparing different high compression systems meant the review was unable to draw conclusions about their relative merit. Four of these trials have compared 4-layer bandage with short stretch technologies--the most commonly used technologies in Canada. In total, these trials involved only 220 patients, and were thus underpowered. Furthermore, they did not consider factors such as client preference and ease of use, or incorporate an economic evaluation.
Plan of Investigation:
The study will be a multi-centre, pragmatic, randomised trial of two types of compression bandaging technologies, incorporating an economic evaluation.
Research objective: To compare the effectiveness of 2 high compression technologies delivered in the community on ulcer healing, recurrence rates, quality of life, and cost-effectiveness.
Interventions: Four-layer bandage vs. Short-stretch bandage. Sample size: 414 total, 207 in each arm (80% power, " 0.05 to detect 4 week difference in time to heal).
Inclusion Criteria: leg ulcer>1 cm in any one dimension, minimum duration of 1 week, ABPI>0.7.
Randomization: will be carried out and stratified by: Clinical Centre (3 Health Regions in Ontario); Margolis' Prognostic Model (ulcer area and duration), Ulcer episode (1st or recurrent ulcer).
Analysis: Primary outcome: time-to-healing of the reference ulcer.
Secondary outcomes: quality of life \& expenditures for treatment. Durability of healing will be assessed-follow-up for up to 52 weeks post-healing to determine recurrence rates associated with both technologies.
Summary:
There is consensus internationally in recommending the application of graduated multi-layer compression. High compression is more effective than low compression; however, there is no clear evidence as to which high compression technology is more effective.
- Conditions
- Venous Ulcer
- Being tested
- Four-layer Bandage (Elastomeric), Short-stretch Bandage (Non-elastomeric)
- Keywords
- leg ulcer, compression, bandage, APBI, venous insufficiency
- Medical subject headings
- Varicose Ulcer, Leg Ulcer, Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Four-layer Bandage (Elastomeric)Device
Also called Profore bandaging system (Smith & Nephew Medical Ltd.)
Precise components of the four-layer system depend on the circumference of the ankle. All the bandages are discarded after a single use, usually one week.
Short-stretch Bandage (Non-elastomeric)Device
Also called Comprilan (Beiersdorf-Jobst, Inc.)
These bandages are applied in a figure-eight technique; two bandages are applied at full extension in opposite directions up the leg (i.e., clockwise and counter clockwise). The participant will wash the short-stretch wherever possible and reused. The number of bandages supplied to each patient will be recorded on the visit record.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Clients randomized to short-stretch bandaging application Receives: Device: Short-stretch Bandage (Non-elastomeric) |
| 2 | Active comparator | Clients randomized to four-layer bandaging application Receives: Device: Four-layer Bandage (Elastomeric) |
What is being measured
The primary outcome is the main question the study is designed to answer.
4 weeks or greater improvement in time-to-healing with short-stretch bandages compared to the four-layer bandaging system
Measured: Time to healing or up to 12 months; post-healing follow-up
Secondary outcomes (4)
rate of reduction in ulcer area
Measured: Baseline and time of healing
quality of life
Measured: Baseline and every 3 months
expenditures over a one-year follow-up
Measured: From baseline to time of healing
Recurrence
Measured: Status recorded at last visit of each month; one year post-healing follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionMar 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 426 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Dr. Margaret Harrison, Queen's University
- Investigators
- Margaret B Harrison, PhD, Principal investigator, Queen's UniversityIan D Graham, PhD, Principal investigator, University of Ottawa (co-investigator)Elizabeth A Nelson, PhD, Study director, University of Leeds, UK (co-investigator)Karen Lorimer, MNSc, Study director, Victorian Order of Nurses (co-investigator)Connie Harris, MNSc, Study director, ET NOW (co-investigator)Elizabeth VanDenKerkhof, PhD, Study director, School of Nursing, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00202267
- Sponsor's protocol ID
- MCT 63175
- Other IDs
- 394622
- Status last verified
- Nov 2015
- First submitted
- 16 Sep 2005
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vandenkerkhof EG, Hopman WM, Carley ME, Kuhnke JL, Harrison MB. Leg ulcer nursing care in the community: a prospective cohort study of the symptom of pain. BMC Nurs. 2013 Feb 6;12:3. doi: 10.1186/1472-6955-12-3.
PubMed 23388350Pham B, Harrison MB, Chen MH, Carley ME; Canadian Bandaging Trial Group. Cost-effectiveness of compression technologies for evidence-informed leg ulcer care: results from the Canadian Bandaging Trial. BMC Health Serv Res. 2012 Oct 2;12:346. doi: 10.1186/1472-6963-12-346.
PubMed 23031428Harrison MB, Vandenkerkhof EG, Hopman WM, Graham ID, Carley ME, Nelson EA; Canadian Bandaging Trial Group. The Canadian Bandaging Trial: Evidence-informed leg ulcer care and the effectiveness of two compression technologies. BMC Nurs. 2011 Oct 13;10:20. doi: 10.1186/1472-6955-10-20.
PubMed 21995267
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Randomised Control Trial of the Effectiveness of Two Compression Bandaging Technologies
- ClinicalTrials.gov ID
- NCT00202267
- Acronym / sponsor ID
- MCT 63175
- Conditions
- Venous Ulcer
- Keywords
- leg ulcer, compression, bandage, APBI, venous insufficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 426 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2004
- Primary completion
- Mar 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 20 Sep 2005 (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.
Leg ulcers are emotionally distressing and painful, and often require months or years to heal. Although rarely acknowledged as a pressing health care issue, leg ulcers comprise a common, complex, and costly condition, managed primarily through community home care services. Indeed, leg ulcers are the most frequently seen and treated chronic wound. There is consensus in recent international, evidence-based practice guidelines that graduated, multi-layer compression is the most effective treatment, and greatly reduces healing time. High compression is more effective than low compression. However, there is no clear evidence as to which high compression technology is the most effective in promoting healing, the most acceptable to patients, or the most cost-effective to the health care system. This study is designed to answer these questions through a randomized trial conducted in the community, where most leg ulcer care currently takes place. Issues such as effectiveness in healing, quality of life, physical discomfort, personal preference, cost to the system and to the individual will be taken into consideration in evaluating two most commonly used types of compression bandaging.
Detailed description
Background:
Although rarely recognized as a pressing health care problem, leg ulcers comprise a common, complex, and costly condition. Over 80% of ongoing management of chronic wounds occurs in the community, and leg ulcers are one of the most frequently seen chronic wounds. The cost of leg ulcer care is considerable, being reported in both the UK and France to account for 2% of their total national health budgets. In Canada, the impact is only now being recognized due to the pressure on home care caseloads resulting from hospital downsizing, nursing shortages, and growing numbers of complex health populations. In one Ontario study, the care for fewer than 200 community leg ulcer cases cost in excess of $1.5 million for supplies and nursing visits, which translates to $100s of millions yearly Canada-wide. The impact on the individual is significant--chronic, painful, and often takes years to heal. Two-thirds of individuals with leg ulcers have at least one recurrence, and 45% have a history with the condition dating back 10 years.
State of Knowledge \& Clinical Practice Guidelines:
Over the past decade, evidence from RCT studies and a recent Cochrane systematic review in BMJ demonstrated that venous leg ulcers treated with compression therapy are more likely to heal. Multi-layer high compression systems are more effective than low compression. However, the small number of people in trials comparing different high compression systems meant the review was unable to draw conclusions about their relative merit. Four of these trials have compared 4-layer bandage with short stretch technologies--the most commonly used technologies in Canada. In total, these trials involved only 220 patients, and were thus underpowered. Furthermore, they did not consider factors such as client preference and ease of use, or incorporate an economic evaluation.
Plan of Investigation:
The study will be a multi-centre, pragmatic, randomised trial of two types of compression bandaging technologies, incorporating an economic evaluation.
Research objective: To compare the effectiveness of 2 high compression technologies delivered in the community on ulcer healing, recurrence rates, quality of life, and cost-effectiveness.
Interventions: Four-layer bandage vs. Short-stretch bandage. Sample size: 414 total, 207 in each arm (80% power, " 0.05 to detect 4 week difference in time to heal).
Inclusion Criteria: leg ulcer>1 cm in any one dimension, minimum duration of 1 week, ABPI>0.7.
Randomization: will be carried out and stratified by: Clinical Centre (3 Health Regions in Ontario); Margolis' Prognostic Model (ulcer area and duration), Ulcer episode (1st or recurrent ulcer).
Analysis: Primary outcome: time-to-healing of the reference ulcer.
Secondary outcomes: quality of life \& expenditures for treatment. Durability of healing will be assessed-follow-up for up to 52 weeks post-healing to determine recurrence rates associated with both technologies.
Summary:
There is consensus internationally in recommending the application of graduated multi-layer compression. High compression is more effective than low compression; however, there is no clear evidence as to which high compression technology is more effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: Short-stretch Bandage (Non-elastomeric)Clients randomized to short-stretch bandaging application |
| 2 | Active comparator | Device: Four-layer Bandage (Elastomeric)Clients randomized to four-layer bandaging application |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- clinical presentation of venous insufficiency
- leg ulcer equal to or larger than 0.7 cm in any one dimension
- ulcer a minimum duration of 1 week
- ankle brachial pressure index equal to or greater than 0.80
- participant can provide written consent
Key exclusion criteria (4 listed)
- diagnosed with Diabetes Mellitus - insulin dependent or participant on oral hypoglycemics
- participants who failed to improve over a 3-month period after being treated with either the SS or 4-layer compression bandaging system prior to the trial
- previous trial patients (ie individuals previously enrolled in the study but now have recurrence or a new ulcer)
- symptoms of cognitive impairment noted
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 |
|---|---|---|
| Four-layer Bandage (Elastomeric)Also: Profore bandaging system (Smith & Nephew Medical Ltd.)Precise components of the four-layer system depend on the circumference of the ankle. All the bandages are discarded after a single use, usually one week. | Device | 2 |
| Short-stretch Bandage (Non-elastomeric)Also: Comprilan (Beiersdorf-Jobst, Inc.)These bandages are applied in a figure-eight technique; two bandages are applied at full extension in opposite directions up the leg (i.e., clockwise and counter clockwise). The participant will wash the short-stretch wherever possible and reused. The number of bandages supplied to each patient will be recorded on the visit record. | Device | 1 |
Primary outcome
4 weeks or greater improvement in time-to-healing with short-stretch bandages compared to the four-layer bandaging system
Time frame: Time to healing or up to 12 months; post-healing follow-up
4 secondary outcomes
rate of reduction in ulcer area
Time frame: Baseline and time of healing
quality of life
Time frame: Baseline and every 3 months
expenditures over a one-year follow-up
Time frame: From baseline to time of healing
Recurrence
Time frame: Status recorded at last visit of each month; one year post-healing follow-up
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 20 Nov 2015.
- Derived from this study: PubMed 23388350Vandenkerkhof EG, Hopman WM, Carley ME, Kuhnke JL, Harrison MB. Leg ulcer nursing care in the community: a prospective cohort study of the symptom of pain. BMC Nurs. 2013 Feb 6;12:3. doi: 10.1186/1472-6955-12-3.
- Derived from this study: PubMed 23031428Pham B, Harrison MB, Chen MH, Carley ME; Canadian Bandaging Trial Group. Cost-effectiveness of compression technologies for evidence-informed leg ulcer care: results from the Canadian Bandaging Trial. BMC Health Serv Res. 2012 Oct 2;12:346. doi: 10.1186/1472-6963-12-346.
- Derived from this study: PubMed 21995267Harrison MB, Vandenkerkhof EG, Hopman WM, Graham ID, Carley ME, Nelson EA; Canadian Bandaging Trial Group. The Canadian Bandaging Trial: Evidence-informed leg ulcer care and the effectiveness of two compression technologies. BMC Nurs. 2011 Oct 13;10:20. doi: 10.1186/1472-6955-10-20.
- Queen's University homepageLink provided by the sponsor.
- Canadian Institutes of Health ResearchLink provided by the sponsor.
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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.
Margaret B Harrison, PhD principal investigator
Queen's University
Ian D Graham, PhD principal investigator
University of Ottawa (co-investigator)
Elizabeth A Nelson, PhD study director
University of Leeds, UK (co-investigator)
15 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 Four-layer Bandage (Elastomeric) and Short-stretch Bandage (Non-elastomeric) in people with Venous Ulcer, run by Queen's University at 15 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 7 inclusion and 4 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 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
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?
4 weeks or greater improvement in time-to-healing with short-stretch bandages compared to the four-layer bandaging system (time frame: Time to healing or up to 12 months; post-healing follow-up). 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 NCT00202267, which also lists 3 linked publications.
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 20 Nov 2015.