Community RCT of the Effectiveness of Two Compression Bandaging Technologies
Community Randomised Control Trial of the Effectiveness of Two Compression Bandaging Technologies
2 other identifiers
interventional
426
1 country
15
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2004
Longer than P75 for phase_2
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 16, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedNovember 20, 2015
November 1, 2015
4.2 years
September 16, 2005
November 18, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
4 weeks or greater improvement in time-to-healing with short-stretch bandages compared to the four-layer bandaging system
Time to healing or up to 12 months; post-healing follow-up
Secondary Outcomes (4)
rate of reduction in ulcer area
Baseline and time of healing
quality of life
Baseline and every 3 months
expenditures over a one-year follow-up
From baseline to time of healing
Recurrence
Status recorded at last visit of each month; one year post-healing follow-up
Study Arms (2)
1
ACTIVE COMPARATORClients randomized to short-stretch bandaging application
2
ACTIVE COMPARATORClients randomized to four-layer bandaging application
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Queen's Universitylead
- Canadian Institutes of Health Research (CIHR)collaborator
Study Sites (15)
Winnipeg Regional Health Authority
Winnipeg, Manitoba, R3G 0N6, Canada
Nursing Practice Solutions
Fort Erie, Ontario, L2A 2G4, Canada
VON Hamilton Branch
Hamilton, Ontario, L8L 5G8, Canada
Saint Elizabeth Health Care
Kingston, Ontario, K7L 1G8, Canada
Kingston Chronic Wound Clinic
Kingston, Ontario, K7L 5E4, Canada
ParaMed Health Services
Kingston, Ontario, K7M 8R1, Canada
ET Now
Kitchener, Ontario, N2H 3K5, Canada
Carefor
Ottawa, Ontario, K1K 3B8, Canada
ParaMed Health Services
Ottawa, Ontario, K1Z 6X3, Canada
St. Joseph's Care Group
Thunder Bay, Ontario, P7B 5G7, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
ParaMed Home Health Care
Toronto, Ontario, M5G 1V2, Canada
Comcare Health
Toronto, Ontario, M5S 2T9, Canada
Ostomy and Wound Care Centre
Regina, Saskatchewan, S4S 0S4, Canada
Saskatoon Health Region Home Care
Saskatoon, Saskatchewan, S7H 4W3, Canada
Related Publications (3)
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.
PMID: 23388350DERIVEDPham 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.
PMID: 23031428DERIVEDHarrison 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.
PMID: 21995267DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margaret B Harrison, PhD
Queen's University
- PRINCIPAL INVESTIGATOR
Ian D Graham, PhD
University of Ottawa (co-investigator)
- STUDY DIRECTOR
Elizabeth A Nelson, PhD
University of Leeds, UK (co-investigator)
- STUDY DIRECTOR
Karen Lorimer, MNSc
Victorian Order of Nurses (co-investigator)
- STUDY DIRECTOR
Connie Harris, MNSc
ET NOW (co-investigator)
- STUDY DIRECTOR
Elizabeth VanDenKerkhof, PhD
School of Nursing, Queen's University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 16, 2005
First Posted
September 20, 2005
Study Start
January 1, 2004
Primary Completion
March 1, 2008
Study Completion
December 1, 2008
Last Updated
November 20, 2015
Record last verified: 2015-11