Wound Healing Clinical Trial
Official title:
Phase II Randomised, Placebo Controlled Trial to Investigate Repeat Dose Antimicrobial Photodynamic Therapy in Patients With Chronic Leg Ulcers.
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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