Clinical Trial to Investigate Treatment With Photodynamic Therapy to Reduce Levels of Bacteria in Leg Ulcers
This study has been completed.
Sponsor:
Photopharmica
Information provided by (Responsible Party):
Photopharmica
ClinicalTrials.gov Identifier:
NCT00825760
First received: January 19, 2009
Last updated: January 23, 2013
Last verified: January 2013
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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. 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Leg Ulcers Wound Healing |
Drug: Topical PPA904 gel and light Drug: Topical placebo gel plus light |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase II Randomised, Placebo Controlled Trial to Investigate Repeat Dose Antimicrobial Photodynamic Therapy in Patients With Chronic Leg Ulcers. |
Resource links provided by NLM:
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 ]
| Enrollment: | 57 |
| Study Start Date: | January 2009 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (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, once weekly
|
Drug: Topical PPA904 gel and light Drug: Topical placebo gel plus light |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00825760
Locations
| United Kingdom | |
| Department of Vascular Surgery, Bradford Royal Infirmary | |
| Bradford, United Kingdom, BD9 6RJ | |
| Department of Wound Healing, Cardiff University | |
| Cardiff, United Kingdom, CF14 4XN | |
| Dermatology Department, Ninewells Hospital and Medical School | |
| Dundee, United Kingdom, DD1 9SY | |
| Dermatology Department, Harrogate District Hospital | |
| Harrogate, United Kingdom, HG2 7SX | |
Sponsors and Collaborators
Photopharmica
Investigators
| Principal Investigator: | Keith Harding, MBChB FRCS | Cardiff University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Photopharmica |
| ClinicalTrials.gov Identifier: | NCT00825760 History of Changes |
| Other Study ID Numbers: | PPA/904W/003 |
| Study First Received: | January 19, 2009 |
| Last Updated: | January 23, 2013 |
| 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 |
Additional relevant MeSH terms:
|
Leg Ulcer Ulcer Skin Ulcer Skin Diseases |
Pathologic Processes Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013