Working… Menu

Community RCT of the Effectiveness of Two Compression Bandaging Technologies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00202267
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : November 20, 2015
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. Margaret Harrison, Queen's University

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.

Condition or disease Intervention/treatment Phase
Venous Ulcer Device: Four-layer Bandage (Elastomeric) Device: Short-stretch Bandage (Non-elastomeric) Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 426 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Community Randomised Control Trial of the Effectiveness of Two Compression Bandaging Technologies
Study Start Date : January 2004
Actual Primary Completion Date : March 2008
Actual Study Completion Date : December 2008

Arm Intervention/treatment
Active Comparator: 1
Clients randomized to short-stretch bandaging application
Device: Short-stretch Bandage (Non-elastomeric)
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.
Other Name: Comprilan (Beiersdorf-Jobst, Inc.)

Active Comparator: 2
Clients randomized to four-layer bandaging application
Device: Four-layer Bandage (Elastomeric)
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.
Other Name: Profore bandaging system (Smith & Nephew Medical Ltd.)

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. rate of reduction in ulcer area [ Time Frame: Baseline and time of healing ]
  2. quality of life [ Time Frame: Baseline and every 3 months ]
  3. expenditures over a one-year follow-up [ Time Frame: From baseline to time of healing ]
  4. Recurrence [ Time Frame: Status recorded at last visit of each month; one year post-healing follow-up ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00202267

Layout table for location information
Canada, Manitoba
Winnipeg Regional Health Authority
Winnipeg, Manitoba, Canada, R3G 0N6
Canada, Ontario
Nursing Practice Solutions
Fort Erie, Ontario, Canada, L2A 2G4
VON Hamilton Branch
Hamilton, Ontario, Canada, L8L 5G8
Saint Elizabeth Health Care
Kingston, Ontario, Canada, K7L 1G8
Kingston Chronic Wound Clinic
Kingston, Ontario, Canada, K7L 5E4
ParaMed Health Services
Kingston, Ontario, Canada, K7M 8R1
ET Now
Kitchener, Ontario, Canada, N2H 3K5
Ottawa, Ontario, Canada, K1K 3B8
ParaMed Health Services
Ottawa, Ontario, Canada, K1Z 6X3
St. Joseph's Care Group
Thunder Bay, Ontario, Canada, P7B 5G7
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
ParaMed Home Health Care
Toronto, Ontario, Canada, M5G 1V2
Comcare Health
Toronto, Ontario, Canada, M5S 2T9
Canada, Saskatchewan
Ostomy and Wound Care Centre
Regina, Saskatchewan, Canada, S4S 0S4
Saskatoon Health Region Home Care
Saskatoon, Saskatchewan, Canada, S7H 4W3
Sponsors and Collaborators
Queen's University
Canadian Institutes of Health Research (CIHR)
Layout table for investigator information
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
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dr. Margaret Harrison, Principal Investigator, Queen's University Identifier: NCT00202267    
Other Study ID Numbers: MCT 63175
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015
Keywords provided by Dr. Margaret Harrison, Queen's University:
leg ulcer, compression, bandage, APBI, venous insufficiency
Additional relevant MeSH terms:
Layout table for MeSH terms
Varicose Ulcer
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases