Extrait

Background and study aims? Diabetes affects more than 2 percent of the UK population, and is linked with important health problems such as diabetic foot ulcers. About a quarter of people with diabetes will develop a foot ulcer in their lifetime, which can lead to reduced quality of life and higher personal and healthcare costs. Over half of patients with diabetic foot ulcers will have a wound infection. In order to provide the best treatment it is important to understand the cause of the infection. Because many different bacteria can cause diabetic foot infections, obtaining a wound sample is an important part of providing the best care. A sample from the ulcer is examined in the laboratory to find out which bacteria are causing the infection. This information allows the doctor to prescribe the most suitable antibiotic treatment for the infection. In current practice, most doctors collect a sample for analysis by wiping the infected wound with a cotton swab. These swabs are widely available, cheap and easy to use. However, some doctors think it is better to take a little piece of the infected ulcer (a curettage sample) in order to identify the harmful bacteria causing the infection. This study is designed to find out if these two different ways of collecting samples from diabetic foot ulcers give the same answers, or if one is better than the other. Who can participate? Patients who • Suffer from diabetes (either type I or type II) • Are 18 and over • Are suspected of having an infected foot ulcer, which will be treated using antibiotics. What does the study involve? Once a patient has agreed to take part in the study, their doctor will take a sample from the infected wound using the usual swab technique, but will also take a curettage sample as well. Both samples will be sent to the hospital laboratory for analysis. Once the samples have been taken, the study requires no further patient involvement. What are the possible benefits and risks of participating? The risks to patients in this study are minimal. The method used to obtain the curettage sample requires scraping of the ulcer which may lead to some bleeding or pain. The benefits include better treatment of patients who have an infected foot ulcer and as a consequence better long term health. Where is the study run from? Patients will be recruited from both hospital and community clinics. The aim of the study is to recruit 400 patients from 20 different centres. When is the study starting and how long is it expected to run for? Recruitment will begin in October 2011 and will run for 15 months until January 2013. Who is funding the study? This study is funded by the National Institute for Health Research Health Technology Assessment (NIHR HTA). Who is the main contact? Professor Andrea Nelson [email protected]

Critère d'inclusion

• Diabetic Foot Ulcers (DFU)

Liens

• isrctn
• ictrp