Is the Short-stretch bandage or the 4-layer bandage more effective in treating leg ulcers?

ISRCTN	ISRCTN37782978
DOI	https://doi.org/10.1186/ISRCTN37782978
ClinicalTrials.gov (NCT)	NCT00202267
Protocol serial number	MCT-63175
Sponsor	Queen's University (Canada)
Funder	Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: MCT-63175)

Submission date: 01/03/2006
Registration date: 01/03/2006
Last edited: 22/05/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Margaret B. Harrison
Scientific

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

Phone	+1 613 533 6000 ext 74760
Email	Margaret.B.Harrison@queensu.ca

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Community randomised controlled trial on the effectiveness of two compression bandaging technologies
Study acronym	CBT (Canadian Bandaging Trial)
Study objectives	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(s)	Research Ethics Board of Queen's University Health Sciences and Affiliated Teaching Hospitals, Kingston, Ontario (Canada) approved on the 8th July 2003. Renewed annually.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Time-to-healing of the reference ulcer (comparison of four-layer and short-stretch over 4 week period)
Key secondary outcome measure(s)	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
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	424
Key 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
Key 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
Date of first enrolment	11/01/2003
Date of final enrolment	31/12/2009

Locations

Countries of recruitment

Canada

Study participating centre

Professor, School of Nursing

Kingston
K7L 3N6
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	02/10/2012		Yes	No