E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic leg ulcers and chronic diabetic foot ulcers |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Determine whether antimicrobial photodynamic therapy using the combined effect of 3,7-bis(N,N-dibutylamino) phenothiazin-5-ium bromide (PPA904) and light can reduce the bacterial content of chronic leg ulcers and diabetic foot ulcers. |
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E.2.2 | Secondary objectives of the trial |
Monitor ulcer topography during the period of the study. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Subjects will be required to satisfy the following criteria: Subjects will be males or post-menopausal females or females of non-childbearing potential of over 40 years of age. Subjects will have chronic leg or diabetic foot ulcers. Subjects should be of appropriate health to participate in the study, as determined by the Principal Investigator. This will be determined by a medical history, physical examination, 12-lead ECG and clinical laboratory evaluations. Subjects will have ulcers that have been present for at least 3 months. Subjects will have ulcers with greater than 100,000 colony forming units per cm sq. Subjects will have to give their written informed consent to participate in the study and to abide by the study restrictions. |
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E.4 | Principal exclusion criteria |
Subjects with photosensitivity disorders. Subjects with systemic infection. Patients who have taken topical or systemic antibiotics one month prior to treatment. Subjects with an ulcer size of greater than 10cm in diameter or 100 cm sq. Subjects who have received any other investigational drug with 4 months prior to screening or enrolment. Subjects with any concomitant condition that, in the opinion of the investigator would preclude evaluation of response or make it unlikely that the follow up could be completed. Subjects with a concomitent infection that needs to be treated with an addditional antimicrobial agent. subjects who show signs of acute on chronic infection (heat, pain, redness or swelling). Subjects who, in the opinion of their General Practitioner or the Investigator, should not participate in the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Quantitative measure of the bacterial load of the ulcer immediately post-dose and photodynamic therapy compared with that immediately prior to dose application and photodynamic therapy. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Blinded - please see protocol for further details |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
The Unguentum M cream that the API is formulated in minus the API will be used as the placebo |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The trial will involve a single topical treatment. Quantitative bacteriology following the treatment will be carried out up to one month post treatment. Measurement of wound area will be carried out up to 3 months post treatment. The end of the trial is defined as after the 3 month wound measurment. However, this is a follow up analysis and the therapeutic part of the trial is completed on day 1. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |