NCT02392390已完成不适用
Effects of Topical Dynamic Phototherapy (TDP) on the Microbiota of Chronic Wounds: a Pilot Study
Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2015年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample
研究概览
简要总结
The main objective of this study is to estimate the change in the relative numbers of commensal or low virulence potential bacteria before and after one session TDP.
详细描述
The secondary objectives of this study are:
- To estimate changes in several microbiological parameters over three time periods (before treatment, after applying the Metvixia® and after irradiation during a single TDP session).
- Describe the evolution of the size and appearance of the wound 7d after the start of treatment
- Describe the potential adverse events associated with a TDP session
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient correctly informed concerning study implementation, objectives, constraints and patient rights
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient presents with one or more leg ulcers (artieral, venous or mixed)
- •Afebrile patient without periulcerous erythema and who does not require antibiotic therapy
- •Patient who has not received antibiotic treatment during the last 7 Days
- •Nota bene: Patients with multiple ulcers at different stages will be included for the wound corresponding to the highest stage. If the patient has multiple ulcers atn the same stage, the deepest wound will be considered.
排除标准
- •The patient is participating in another interventional study, has participated in another interventional study with the past 3 months, or is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant, parturient, or breastfeeding
- •The patient has a contraindication for a treatment used in this study
- •Patient with an infected leg ulcer treated with antibiotics
- •Patients on curative anticoagulation
研究组 & 干预措施
The study population
Experimental
A total of 10 leg ulcer patients will be recruted for this study. All will have the experimental treatment.
Intervention: Topical Dynamic Phototherapy (TDP)
干预措施: Topical Dynamic Phototherapy (TDP) (Procedure)
The study population
Experimental
A total of 10 leg ulcer patients will be recruted for this study. All will have the experimental treatment.
Intervention: Topical Dynamic Phototherapy (TDP)
干预措施: Metvixia cream (Drug)
结局指标
主要结局
The percentage of commensal or weak virulence potential bacteria among all bacteria species isolated per sample
时间窗: Day 0: immediately after phototherapy
次要结局
- The diversity of functional groups detected per sample (Shannon's H with log2)(Day 0: immediately after phototherapy)
- Visual analog scale for pain during the phototherapy session(Day 0)
- The diversity of bacteria taxa detected per sample (Shannon's H with log2)(Day 0: immediately after phototherapy)
- The number of functional groups detected per sample(Day 0: immediately after phototherapy)
- Adverse events(Day 7)
- The percentage of commensal bacteria among bacteria species isolated per sample(Day 0: immediately after phototherapy)
- The number of bacteria taxa detected per sample(Day 0: immediately after phototherapy)
研究者
研究点 (1)
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