Randomised controlled trial (RCT) and economic modelling to evaluate the place of anti-microbial agents in the management of venous leg ulcers

Completed

Conditions: Venous ulcers
Circulatory System

Registration Number: ISRCTN72485131

Lead Sponsor: Department of Health (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 300

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measures as of 08/09/2009:<br>1. Number of ulcers completely healed at 12 weeks<br>2. Cost data from the RCT and observation arms at 12 weeks<br><br>Information provided at time of registration:<br>1. Cost data will be collected from the observational database and RCT <br>2. Clinical end point for the RCT group: time to complete healing of the leg ulcer

Secondary Outcome Measures

Name	Time	Method
Current information as of 08/09/2009: <br>1. Recurrence rate at six months and one year<br>2. Quality of life (SF-36® Health Survey, Euroqol EQ-5D and Standard Gamble [SG]) at 1, 3, 6 and 12 months<br>3. Symptomatic data (including pain) collected weekly until 12 weeks or ulcer healed<br><br>Information provided at time of registration: <br>1. Recurrence rate <br>2. Quality of life (SF-36® Health Survey, Euroqol EQ-5D and Standard Gamble [SG]) <br>3. Symptomatic measures, including pain