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Community RCT of the Effectiveness of Two Compression Bandaging Technologies

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Margaret Harrison, Queen's University
ClinicalTrials.gov Identifier:
NCT00202267
First received: September 16, 2005
Last updated: October 21, 2011
Last verified: October 2011
  Purpose

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 Intervention Phase
Venous Ulcer
Device: Four-layer Bandage (Elastomeric)
Device: Short-stretch Bandage (Non-elastomeric)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Community Randomised Control Trial of the Effectiveness of Two Compression Bandaging Technologies

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • rate of reduction in ulcer area [ Time Frame: Baseline and time of healing ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: Baseline and every 3 months ] [ Designated as safety issue: No ]
  • expenditures over a one-year follow-up [ Time Frame: From baseline to time of healing ] [ Designated as safety issue: No ]
  • Recurrence [ Time Frame: Status recorded at last visit of each month; one year post-healing follow-up ] [ Designated as safety issue: No ]

Enrollment: 426
Study Start Date: January 2004
Study Completion Date: December 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00202267

Locations
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
Kingston Chronic Wound Clinic
Kingston, Ontario, Canada, K7L 5E4
ParaMed Health Services
Kingston, Ontario, Canada, K7M 8R1
Saint Elizabeth Health Care
Kingston, Ontario, Canada, K7L 1G8
ET Now
Kitchener, Ontario, Canada, N2H 3K5
Carefor
Ottawa, Ontario, Canada, K1K 3B8
ParaMed Health Services
Ottawa, Ontario, Canada, K1Z 6X3
St. Joseph's Care Group
Thunder Bay, Ontario, Canada, P7B 5G7
Comcare Health
Toronto, Ontario, Canada, M5S 2T9
ParaMed Home Health Care
Toronto, Ontario, Canada, M5G 1V2
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
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)
Investigators
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
  More Information

Additional Information:
No publications provided by Queen's University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Margaret Harrison, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT00202267     History of Changes
Other Study ID Numbers: MCT 63175, 394622
Study First Received: September 16, 2005
Last Updated: October 21, 2011
Health Authority: Canada: Health Canada

Keywords provided by Queen's University:
leg ulcer, compression, bandage, APBI, venous insufficiency

Additional relevant MeSH terms:
Varicose Ulcer
Cardiovascular Diseases
Leg Ulcer
Skin Diseases
Skin Ulcer
Varicose Veins
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014