EUCTR2008-005079-90-GB进行中（未招募）1 期
Phase II randomised, placebo controlled trial to investigate repeat dose antimicrobial photodynamic therapy in patients with chronic leg ulcers
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 69
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
排除标准
- •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.
研究者
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