Clinical Trial to Investigate Treatment With Photodynamic Therapy to Reduce Levels of Bacteria in Leg Ulcers - Full Text View

Sponsors and Collaborators:	Photopharmica Cardiff University
Information provided by:	Photopharmica
ClinicalTrials.gov Identifier:	NCT00825760

Purpose

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. At the moment we are not sure of how many times it is best to use this treatment, so the second part of the study will compare whether or not using the treatment twice a week for 6 weeks is any better than once a week for 12 weeks.

Across the UK 105 people with chronic venous leg ulcers will be asked to take part in this study (9 in part 1 and 96 in part 2). Up to 10 sites will be involved including Cardiff University and hospitals in Bradford, Harrogate, Dundee, Truro and Airdrie.

The research is funded by Photopharmica Ltd.

Condition	Intervention	Phase
Chronic Venous Leg Ulcers Wound Healing	Drug: Topical PPA904 gel and light Drug: Topical placebo gel plus light	Phase II

MedlinePlus related topics: Leg Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Phase II Randomised, Placebo Controlled Trial to Investigate Repeat Dose Antimicrobial Photodynamic Therapy in Patients With Chronic Venous Leg Ulcers.

Further study details as provided by Photopharmica:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. ] [ Designated as safety issue: No ]
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). ] [ Designated as safety issue: No ]
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). ] [ Designated as safety issue: No ]
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). ] [ Designated as safety issue: No ]
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). ] [ Designated as safety issue: Yes ]
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). ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	105
Study Start Date:	January 2009
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Single treatment	Drug: Topical PPA904 gel and light Drug: Topical placebo gel plus light
2 12 treatments, twice weekly	Drug: Topical PPA904 gel and light Drug: Topical placebo gel plus light
3 12 treatments, once weekly	Drug: Topical PPA904 gel and light Drug: Topical placebo gel plus light

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects will be males or post-menopausal females or females of non-childbearing potential over 40 years of age.
Subjects will have a chronic venous leg ulcer with an ABPI ≥ 0.8 (measured at screening).
Subjects will have an ulcer that has been present for at least 3 months and not more than 2 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 40 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, or oral or parental chronic immunosuppressants within 90 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825760

Contacts

Contact: Kirste Mellish, BSc PhD

0113 3845632

kirste@photopharmica.com

Locations

United Kingdom
Dermatology Department, Ninewells Hospital and Medical School	Recruiting
Dundee, United Kingdom, DD1 9SY
Contact: Susan Morley s.morley@nhs.net
Contact: Alyson Bryden a.bryden@nhs.net
Principal Investigator: Susan Morley, MD FRCP
Sub-Investigator: Alyson Bryden
Dermatology Department, Harrogate District Hospital	Not yet recruiting
Harrogate, United Kingdom, HG2 7SX
Contact: Alison Layton ALISON.LAYTON@hdft.nhs.uk
Principal Investigator: Alison Layton, MBChB FRCP
Sub-Investigator: Benjamin Walker
Dermatology Department, Monklands Hospital	Not yet recruiting
Airdrie, United Kingdom, ML6 0JS
Contact: Freida Shaffrali Freida.Shaffrali@lanarkshire.scot.nhs.uk
Contact: Girish Gupta Girish.Gupta@lanarkshire.scot.nhs.uk
Principal Investigator: Freida Shaffrali, MBBS MRCP
Sub-Investigator: Girish Gupta
Department of Wound Healing, Cardiff University	Recruiting
Cardiff, United Kingdom, CF14 4XN
Contact: Keith Harding hardingkg@Cardiff.ac.uk
Contact: Nicola Ivins ivinsnm@Cardiff.ac.uk
Principal Investigator: Keith Harding, MBChB FRCS
Cornwall Dermatology Research	Not yet recruiting
Truro, United Kingdom, TR1 3HD
Contact: Sandra Campbell Sandra.Campbell@rcht.cornwall.nhs.uk
Contact: Alison Curnow alison.curnow@pms.ac.uk
Principal Investigator: Sandra Campbell, MBChB MD
Department of Vascular Surgery, Bradford Royal Infirmary	Not yet recruiting
Bradford, United Kingdom, BD9 6RJ
Contact: Peter Vowden peter.vowden@mac.com
Principal Investigator: Peter Vowden, MD FRCS

Sponsors and Collaborators

Photopharmica

Cardiff University

Investigators

Principal Investigator:

Keith Harding, MBChB FRCS

Cardiff University

More Information

Additional Information:

Click here for more information on Photopharmica and how it uses Photodynamic Therapy for dermatology indications. This link exits the ClinicalTrials.gov site

The 'Wound Healing Research Unit, Cardiff University' is a collaborator for this study, This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Photopharmica Ltd ( Dr Kirste Mellish, Senior Programme Manager )
Study ID Numbers:	PPA/904W/003
Study First Received:	January 19, 2009
Last Updated:	March 10, 2009
ClinicalTrials.gov Identifier:	NCT00825760 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: National Health Service; United Kingdom: Research Ethics Committee

Keywords provided by Photopharmica:

Antimicrobial Photodynamic Therapy
Photodynamic Therapy
PDT
Red light
Visible light
Antimicrobial
Antibacterial

Wound healing
Wound management
Leg ulcer
Chronic venous leg ulcer
Chronic wound
Wound therapy
Antimicrobial therapy

Study placed in the following topic categories:

Anti-Bacterial Agents
Skin Diseases
Ulcer
Skin Ulcer
Leg Ulcer

Additional relevant MeSH terms:

Anti-Infective Agents
Pathologic Processes
Skin Diseases
Therapeutic Uses

Ulcer
Skin Ulcer
Pharmacologic Actions
Leg Ulcer

ClinicalTrials.gov processed this record on May 07, 2009