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Clinical Trial to Investigate Treatment With Photodynamic Therapy to Reduce Levels of Bacteria in Leg Ulcers

2014-08-27 03:24:58 | BioPortfolio

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. At the moment we are not sure of how many times it is best to use this treatment, so the second part of the study will compare whether or not using the treatment twice a week for 6 weeks is any better than once a week for 12 weeks.

Across the UK 105 people with chronic leg ulcers will be asked to take part in this study (9 in part 1 and 96 in part 2). Up to 10 sites will be involved including Cardiff University and hospitals in Bradford, Harrogate, Dundee, Truro, Airdrie, Hull, Plymouth and the Wirral.

The research is funded by Photopharmica Ltd.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Chronic Leg Ulcers

Intervention

Topical PPA904 gel and light, Topical placebo gel plus light

Location

Dermatology Department, Monklands Hospital
Airdrie
United Kingdom
ML6 0JS

Status

Recruiting

Source

Photopharmica

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:24:58-0400

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