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

Tracking Information
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; (submitted: January 20, 2009)	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; (submitted: January 20, 2009)	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). ]
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.
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
Condition ICMJE	Chronic Leg Ulcers; Wound Healing
Intervention ICMJE	Drug: Topical PPA904 gel and light; Drug: Topical placebo gel plus light
Study Arms	1 Single treatment Interventions: Drug: Topical PPA904 gel and light Drug: Topical placebo gel plus light; 2 12 treatments, once weekly Interventions: Drug: Topical PPA904 gel and light Drug: Topical placebo gel plus light
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 8, 2011)	57
Original Estimated Enrollment ICMJE; (submitted: January 20, 2009)	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: Subjects will be males or females of non-childbearing status over 18 years of age.; Subjects will have a chronic leg ulcer with an ABPI ≥ 0.6 (measured at screening).; Subjects will have an ulcer that has been present for at least 3 months and not more than 3 years.; Subjects will have an ulcer with an area of 2 - 100cm2 and a maximum linear dimension of 10cm.; Subjects will have an ulcer with a total bacterial load of ≥ 104 CFU / cm2, determined within 2 weeks before the first treatment.; Subjects will have voluntarily signed and dated a subject Informed Consent Form (ICF).; Subjects will be, in the opinion of the Investigator, able to understand the study, co-operate with the study procedures and be willing to return to the clinic for all the required follow-up visits.; Subjects should be of appropriate health to participate in the study, as determined by the Investigator. This will be determined by a medical history, physical examination, 12-lead ECG and clinical laboratory evaluations. Exclusion Criteria: Subjects under the age of 18 years of age.; Subjects who have taken topical or systemic antibiotics during the 2 weeks prior to screening.; Subjects who have used any anti-microbial dressing or topical antiseptic / antimicrobial or received maggot therapy during the 2 weeks prior to screening.; Subjects who have evidence of connective tissue disorders e.g. vasculitis or rheumatoid arthritis under active treatment.; Subjects who have any clinically significant medical condition that would impair wound healing as determined by the investigator, including uncontrolled diabetes as determined by HbA1C (>12%) or immune disease.; Subjects who are known to abuse alcohol or drugs currently, or to have psychological disorders that could affect follow-up care or treatment outcomes.; Subjects who have received short course corticosteroids within 30 days prior to treatment.; Subjects who have participated in a clinical trial of any investigational drug within 4 months prior to treatment.; Subjects who have participated in a clinical trial of any investigational device, for example dressings, within 1 month prior to treatment.; Subjects who have previously been treated with IMP in this trial.; Subjects who have or are suspected of having malignancy, or who have received treatment for any active malignancy, apart from non-melanomatic skin cancer, within 3 months prior to treatment.; Subjects with evidence of exposed bone, tendon or facia visible around the target wound.; Subjects with photosensitivity disorders.; Subjects with systemic infection, whether or not related to their ulcer.; Subjects with clinically relevant (assessed by PI) active wound infection undergoing treatment.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
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	Principal Investigator: Keith Harding, MBChB FRCS Cardiff University
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