Clinical Trial to Investigate Treatment With Photodynamic Therapy to Reduce Levels of Bacteria in Leg Ulcers
Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
Participant gender:
Summary
Some leg ulcers do not seem to respond that well to the standard treatments that we currently
use. One reason for this may be that there are high levels of bacteria in the ulcer which may
be slowing down the rate of healing. Because we need to be careful about when we use
antibiotics, this study will look at another way of killing bacteria in the ulcer. This new
method involves putting a special gel on the ulcer and then shining a particular type of
light (visible red light) onto the ulcer for a short period of time.
In the first part of the study, a single treatment with the gel and light will be
investigated. The second part of the study will compare whether or not using the treatment
once a week for 12 weeks is better than placebo.
Across the UK 57 people with chronic leg ulcers will be asked to take part in this study (9
in part 1 and 48 in part 2). Up to 10 sites will be involved including Cardiff University and
hospitals in Bradford, Harrogate, Dundee, Hull, Plymouth and the Wirral.
The research is funded by Photopharmica Ltd.