Venous leg ulcers Circulatory System Other disorders of veins
Conditions
Interventions
The participants will be randomly allocated to the following two arms (randomisation ratio 1:1):
Intervention group: Compression hosiery
Control group: Four-layer bandaging
Interventions will be re
Sponsors
University of York (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both males and females, aged 18 years or over 2. Patient has at least one venous leg ulcer* 3. Patient has an ankle brachial pressure index (ABPI) equal to or greater than 0. 8 and <1.2 (taken within last 3 months) 4. Patient is able and willing to tolerate high compression *For the purpose of this study a leg ulcer will be considered as any break in the skin on the leg (below the knee and above the malleoli) which as either (a) been present for more than six weeks or (b) occurs in a person with a history of venous leg ulceration. A participant will be considered to have a purely venous leg ulcer where clinically no other aetiology is suspected. Clinical history must be considered and the study participant must have an ABPI of equal to or greater than 0.8. The ulcer must also be venous in appearance (i.e. moist, shallow, irregular shape, venous eczema, ankle oedema).
Exclusion criteria
Exclusion criteria: 1. Leg ulcer of non-venous aetiology (i.e. arterial) 2. Wound exudate levels too high for the use of compression hosiery (nurse judgement) 3. Patient has very bony prominences at risk of pressure damage 4. Patients are unable or do not wish to consent to participation in the trial 5. Patients are currently in another study evaluating treatments for their leg ulcer 6. Known allergy to any trial product 7. Patient has previously been in this trial 8. People with diabetes mellitus whose blood sugar not well controlled (HbA1c greater than 10% taken within the last three months). (Patients with well controlled diabetes HbA1c less than or equal to 10% are eligible for the trial)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to ulcer healing. Total duration of follow-up: 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cost of treatments. Total duration of follow-up: 12 months. 2. Quality of life (QOL), assessed by SF-12® Health Survey, Euroqol EQ-5D, and Venous Insufficiency Epidemiological and Economic Study (VEINES)-QOL questionnaire every 3 months for 12 months 3. Patient concordance with treatment. Any changes to treatment will be recorded by nurses throughout the trial (Total duration of follow-up: 12 months). At 1 month, a postal questionnaire will be sent to participants in the intervention group to collect data on how often they wear the hosiery. 4. Recurrence. Total duration of follow-up: 12 months. | — |
Countries
United Kingdom
Outcome results
None listed