Venous ulcers Circulatory System Venous ulcers
Conditions
Interventions
RCT group:
One group will have a standard non-adherent dressing applied beneath compression bandages. The other will have an anti-microbial dressing applied beneath compression bandages.
Added as of
Sponsors
Department of Health (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 07/09/2009: Patients with an unhealed venous leg ulcer that had been present for longer than 6 weeks. Inclusion criteria provided at time of registration: Patients with an unhealed venous leg ulcer.
Exclusion criteria
Exclusion criteria: Added as of 07/09/2009: 1. Refusal to give informed consent to participating in the RCT 2. Insulin controlled diabetes mellitus 3. Pregnancy 4. Sensitivity or specific contra-indications to the use of silver 5. Ankle/brachial pressure index of less than 0.8 in the affected leg 6. Leg ulcers with a maximum diameter of less than one centimetre 7. Atypical ulcers, including those where there was suspicion of malignancy, co-existing skin conditions, or vasculitis 8. Patients on oral or parenteral antibiotic treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 08/09/2009: 1. Number of ulcers completely healed at 12 weeks 2. Cost data from the RCT and observation arms at 12 weeks Information provided at time of registration: 1. Cost data will be collected from the observational database and RCT 2. Clinical end point for the RCT group: time to complete healing of the leg ulcer | — |
Secondary
| Measure | Time frame |
|---|---|
| Current information as of 08/09/2009: 1. Recurrence rate at six months and one year 2. Quality of life (SF-36® Health Survey, Euroqol EQ-5D and Standard Gamble [SG]) at 1, 3, 6 and 12 months 3. Symptomatic data (including pain) collected weekly until 12 weeks or ulcer healed Information provided at time of registration: 1. Recurrence rate 2. Quality of life (SF-36® Health Survey, Euroqol EQ-5D and Standard Gamble [SG]) 3. Symptomatic measures, including pain | — |
Countries
United Kingdom
Outcome results
None listed