Condition category
Circulatory System
Date applied
01/03/2006
Date assigned
01/03/2006
Last edited
22/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Margaret B. Harrison

ORCID ID

Contact details

Professor
School of Nursing
Director
Joanna Briggs Collaboration
Senior Scientist
Practice and Research in Nursing Group
Queen's University
90 Barrie Street
Kingston
K7L 3N6
Canada
+1 613 533 6000 ext 74760
Margaret.B.Harrison@queensu.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00202267

Protocol/serial number

MCT-63175

Study information

Scientific title

Community randomised controlled trial on the effectiveness of two compression bandaging technologies

Acronym

CBT (Canadian Bandaging Trial)

Study hypothesis

To determine whether there is a 4 weeks or greater improvement in time-to-healing with short-stretch bandages compared to the four-layer bandaging system; the time to complete healing of the reference ulcer (one year randomisation, follow-up to 30 months).

As of 08/05/2009 this record was updated to include changes to the protocol. All changes can be found under the relevant field. At this time the anticipated end date of this trial was also updated; the initial end date at the time of registration was 30/09/2007.

Ethics approval

Research Ethics Board of Queen's University Health Sciences and Affiliated Teaching Hospitals, Kingston, Ontario (Canada) approved on the 8th July 2003. Renewed annually.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Venous ulcer (leg)

Intervention

Four-layer bandage versus short-stretch bandage for four weeks with a follow-up until 12 months after healing in some cases until a maximum of 30 months

Trial details received: 12 Sept 2005.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Time-to-healing of the reference ulcer (comparison of four-layer and short-stretch over 4 week period)

Secondary outcome measures

Current information as of 08/05/2009:
Over a one-year follow-up:
1. Rate of reduction in ulcer area for a maximum of 30 months
2. Proportion of ulcers healed at 12 and 24 weeks in each arm
2. Durability of Healing: Recurrence rates during 12 months after healing
3. Quality of life (McGill Short Form Pain Questionnaire; SF-12; EuroQol on five dimensions-Mobility, self care, usual activities, pain/discomfort and anxiety depression) at 12 months after healing
4. Expenditures for treatment

Initial information at time of registration
Over a one-year follow-up:
1. Rate of reduction in ulcer area for a maximum of 30 months
2. Recurrence rates during 12 months after healing
3. Quality of life (McGill Short Form Pain Questionnaire; SF-12; self-administered survey) at 12 months after healing
4. Expenditures for treatment

Overall trial start date

11/01/2003

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

Current information as of 08/05/2009:
1. 18 years or older, either sex, ability to communicate in English
2. Could provide written informed consent
3. Had an ulcer of a minimum duration of 1 week
4. Had a clinical presentation of venous insufficiency
5. Had a leg ulcer that measured 0.7 cm in any one dimension
6. Ankle brachial pressure index greater than or equal to 0.8

Initial information at time of registration
1. 18 years or older, either sex, ability to communicate in English
2. Leg ulcer greater than 1 cm in any one dimension, minimum duration of 1 week, Ankle Brachial Pressure Index (ABPI) greater than 0.7

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Added as of 08/05/2009: 424 (previously 414)

Participant exclusion criteria

Current information as of 08/05/2009:
1. Had diabetes (taking insulin or an oral hypoglycaemic)
2. Had failed to improve over a 3-month period after being treated with either bandaging systems prior to the trial
3. Had been a previous study patient
4. Were cognitively impaired

Initial information at time of registration
1. Diagnosis of diabetes mellitus
2. Participants who failed to improve over a 3-month period after being treated previously with either of the trial treatments
3. Previous trial patients
4. Cognitive impairment

Recruitment start date

11/01/2003

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Canada

Trial participating centre

Professor, School of Nursing
Kingston
K7L 3N6
Canada

Sponsor information

Organisation

Queen's University (Canada)

Sponsor details

207 Stuart St
Kingston
K7L 3N6
Canada

Sponsor type

University/education

Website

http://www.queensu.ca/

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63175)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23031428

Publication citations

  1. Results

    Pham B, Harrison MB, Chen MH, Carley ME, , Cost-effectiveness of compression technologies for evidence-informed leg ulcer care: results from the Canadian Bandaging Trial., BMC Health Serv Res, 2012, 12, 346, doi: 10.1186/1472-6963-12-346.

Additional files

Editorial Notes