Phase II randomised, placebo controlled trial to investigate repeat dose antimicrobial photodynamic therapy in patients with chronic leg ulcers

Phase 1

• Conditions: Chronic leg ulcers; MedDRA version: 9.1 Level: LLT Classification code 10066677 Term: Chronic leg ulcer

• Registration Number: EUCTR2008-005079-90-GB
• Lead Sponsor: Photopharmica Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-16
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 69

Inclusion Criteria

To be eligible for the study subjects will be required to satisfy the following criteria:
Subjects will be males or females of non child bearing 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 (Parts 1 and 2 only)
Subjects will have an ulcer that has been present for at least 3 months (Part 3 only).
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.

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

Subjects under the age of 18 years of age.
Subjects who have applied topical antibiotics to the target ulcer or immediate surrounding areas during the 2 weeks prior to screening.
Subjects who have taken 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 on the target ulcer or immediate surrounding areas 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.
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 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.

Additional Exclusion Criteria
Following study assessments at each visit, subjects may be excluded from the study for the following reasons:
Intercurrent illness or clinically significant adverse events.
Subjects who have applied any topical antiseptics / antimicrobials / antibiotics or used antimicrobial dressings to the target ulcer or immediate surrounding areas. . Assessments performed up to the time of application will be included in the analysis.
Subjects who have taken systemic antibiotics. Data up to that point will be included in the analysis.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified