Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-27 @ 11:14 PM
Study NCT ID:
NCT00825760
Status:
COMPLETED
Last Update Posted:
2013-01-24
First Post:
2009-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Investigate Treatment With Photodynamic Therapy to Reduce Levels of Bacteria in Leg Ulcers
Sponsor:
Photopharmica
Organization:
Study Overview
Official Title:
Phase II Randomised, Placebo Controlled Trial to Investigate Repeat Dose Antimicrobial Photodynamic Therapy in Patients With Chronic Leg Ulcers.
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: