Clinical Trial to Investigate Treatment With Photodynamic Therapy to Reduce Levels of Bacteria in Leg Ulcers
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ClinicalTrials.gov Identifier: NCT00825760 |
Recruitment Status
:
Completed
First Posted
: January 21, 2009
Last Update Posted
: January 24, 2013
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Tracking Information | ||||
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First Submitted Date ICMJE | January 19, 2009 | |||
First Posted Date ICMJE | January 21, 2009 | |||
Last Update Posted Date | January 24, 2013 | |||
Study Start Date ICMJE | January 2009 | |||
Actual Primary Completion Date | September 2011 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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. ] | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT00825760 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Clinical Trial to Investigate Treatment With Photodynamic Therapy to Reduce Levels of Bacteria in Leg Ulcers | |||
Official Title ICMJE | Phase II Randomised, Placebo Controlled Trial to Investigate Repeat Dose Antimicrobial Photodynamic Therapy in Patients With Chronic Leg Ulcers. | |||
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. |
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Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
57 | |||
Original Estimated Enrollment ICMJE |
105 | |||
Actual Study Completion Date | September 2011 | |||
Actual Primary Completion Date | September 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00825760 | |||
Other Study ID Numbers ICMJE | PPA/904W/003 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Photopharmica | |||
Study Sponsor ICMJE | Photopharmica | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Photopharmica | |||
Verification Date | January 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |