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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
57
Department of Vascular Surgery, Bradford Royal Infirmary
Bradford, United Kingdom
Department of Wound Healing, Cardiff University
Cardiff, United Kingdom
Dermatology Department, Ninewells Hospital and Medical School
Dundee, United Kingdom
Dermatology Department, Harrogate District Hospital
Harrogate, United Kingdom
To determine if repeat dose antimicrobial photodynamic therapy with PPA904 and PPA Lux 680 can cause a reduction in the bacterial content of chronic leg ulcers.
Time frame: Measurement of total bacterial load of the ulcer immediately before and after each treatment.
Measurement of the levels of specific bacteria, including anaerobes, S.aureus (MSSA and MRSA), P.aeruginosa and beta-haemolytic Streptococci in the ulcer.
Time frame: Immediately before and after each treatment.
Measurement of the ulcer area.
Time frame: Weekly for 12 weeks post the first dose compared to pre the first dose for subjects receiving 12 doses (part 2 of the study).
Assessment of pain.
Time frame: Pre the first dose and weekly for 12 weeks post the first dose for subjects receiving 12 doses (part 2 of the study).
Assessment of quality of life using the Cardiff Wound Impact Schedule
Time frame: Pre the first dose and 12 weeks post the first dose for subjects receiving 12 doses (part 2 of the study).
Measurement of PPA904 levels in peripheral blood samples.
Time frame: Pre-dose and 1h, 3h and 24h post-dose for subjects receiving 1 dose (part 1 of the study).
Safety parameters including: vital signs, 12 lead ECG, blood and urine samples, physical examination and adverse event questioning.
Time frame: 24 hours for subjects receiving 1 dose (part 1 of the study). 6 and 12 weeks post first dose for subjects receiving 12 doses (part 2 of the study).
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