Community RCT of the Effectiveness of Two Compression Bandaging Technologies
This study has been completed.
Sponsor:
Queen's University
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
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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
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 | |
| 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 | |
| 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 | |
| St. Michael's Hospital | |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Comcare Health | |
| Toronto, Ontario, Canada, M5S 2T9 | |
| ParaMed Home Health Care | |
| Toronto, Ontario, Canada, M5G 1V2 | |
| 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:
|
Ulcer Varicose Ulcer Pathologic Processes Varicose Veins Vascular Diseases |
Cardiovascular Diseases Leg Ulcer Skin Ulcer Skin Diseases |
ClinicalTrials.gov processed this record on May 22, 2013