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

Completed

Conditions: Venous ulcer (leg)
Circulatory System
Venous ulcer

Registration Number: ISRCTN37782978

Lead Sponsor: Queen's University (Canada)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 424

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Current information as of 08/05/2009:<br>Over a one-year follow-up:<br>1. Rate of reduction in ulcer area for a maximum of 30 months<br>2. Proportion of ulcers healed at 12 and 24 weeks in each arm<br>2. Durability of Healing: Recurrence rates during 12 months after healing<br>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<br>4. Expenditures for treatment<br><br>Initial information at time of registration<br>Over a one-year follow-up:<br>1. Rate of reduction in ulcer area for a maximum of 30 months<br>2. Recurrence rates during 12 months after healing<br>3. Quality of life (McGill Short Form Pain Questionnaire; SF-12; self-administered survey) at 12 months after healing<br>4. Expenditures for treatment