Chronic leg ulcers and chronic diabetic foot ulcers
Conditions
Interventions
Product Name: 3,7-Bis(di-n-butylamino)phenothiazin-5-ium bromide in Unguentum M
Product Code: PPA904 Unguentum M cream
Pharmaceutical Form: Cream
INN or Proposed INN: 3,7-Bis(di-n-butylamino)phenothi
Sponsors
Photopharmica Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: Monitor ulcer topography during the period of the study.;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. | — |
Countries
United Kingdom
Outcome results
None listed