NCT00825760

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

Phase II Randomised, Placebo Controlled Trial to Investigate Repeat Dose Antimicrobial Photodynamic Therapy in Patients With Chronic Leg Ulcers.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Photopharmica · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Leg Ulcers
• Wound Healing

Interventions

Type	Name	Description
DRUG	Topical PPA904 gel and light
DRUG	Topical placebo gel plus light

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2009-01-21
• Last updated: 2013-01-24

Locations

4 sites across 1 country: United Kingdom