Violet-Blue Light Inactivation of Bacteria in Chronic Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Overall Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE)
研究概览
简要总结
This four-week prospective clinical investigation will assess the safety and feasibility of a medical device without CE-marking. The medical device is a light-emitting-diode (LED) and is manufactured by VulCur MedTech Aps. Violet-blue light treatment is tested on a total of twenty-two patients with chronic wounds, divided into three groups, each group only receiving one dosage. Three dosages (low, medium and high) of violet-blue light treatment is tested. ID 1-7 are assigned to the low group, ID 8-15 are assigned to medium group and ID 16-22 are assigned to the high dosage group.
详细描述
This is as prospective safety and feasibility clinical trial investigating violet-blue light treatment on chronic wounds. This clinical trial runs from Q3 2022 - Q2 2023. Twenty-two patients with chronic wounds will be included (n = 22) for a study-period of four weeks. Week 1 includes one baseline visit. Through Week 2,3 and 4 treatment is given six times with a span of 24-72 hours between every treatment visit. Week 4 includes one follow up-visit. Patients entering the study are assigned to three light dosage groups (low, medium and high) according to their study ID. ID 1-7 are assigned to the low group, ID 8-15 are assigned to medium group and ID 16-22 are assigned to the high dosage group. Between each dosage of light, there will be an evaluation of primary and secondary endpoints by the sponsor and the principal investigator. Light dosage is only escalated should this evaluation be deemed safe. To determine treatment safety skin reactions are assessed after treatment at: 0 minutes, 30 minutes, 24 hours, 48 hours, 5th treatment visit and at follow-up. Adverse Events and Adverse Device Events are evaluated at every visit for every dosage, feasibility is evaluated at follow-up for both patient and investigator. This investigation complies with the Good Clinical Practice concerning medical devices and follows the ISO standard DS/EN 14 155 and the Declaration of Helsinki
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Device Feasibility
- 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
- •Men, women and non-binaries fulfilling all inclusion criteria
- •Age >18 - Patients with a chronic wound defined > 6 weeks
- •Wound Area > 1 cm and < 25 cm
- •Patient can understand Danish
- •Patient can comply with protocol
- •Patient is fully informed about the study and has given informed consent
排除标准
- •Clinical infection in the wound requiring systemic or local antibiotics
- •Current intake of antibiotics or locally applied (within 7 days before baseline)
- •Known or suspected cancer in the wound
- •Previous Photodermatitis and/or Photosensitivity
- •Previous Porphyria and/or hypersensitivity to porphyrins
- •Known congenital or acquired immunodeficiency
- •Newly adjusted or newly started systemic immunomodulate treatment >4 weeks
- •Treatment with haemodialysis
- •Dementia - Participating in other clinical wound healing studies in the last 30 days
- •Judgement by the investigator that the patient is not suited for study participation
- •Pregnant or breastfeeding women. (All fertile women who is not on safe contraception will need a negative pregnancy test performed at baseline. Safe contraception includes cobber and hormone Intra Uterine Device and Hormone anticonception drugs. Sterility is defined as have had surgical sterilisation and being postmenopausal)
结局指标
主要结局
Overall Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE)
时间窗: 4 weeks
Safety is measured as the absence of Adverse Events (AE) skin reactions. Adverse event skin reactions are assessed with the Common Terminology Criteria for Adverse Events U.S Department of Health and Human Services version 5.0, Nov 27, 2017 (CTCAE) adjusted to the skin. The violet-blue light treatment will be considered safe when less than 30 % have an overall CTCAE score larger than Grade 2 CTCAE. The overall CTCAE score for each patient is based on the one CTCAE score with the most severe grading.
次要结局
- Investigator Questionnaire(4 weeks)
- Baseline Clinical Wound Assessment(Baseline, 1 week)
- Mean time of visit(For every visit, up to 4 weeks)
- Change from Baseline Wound Fluid Composition Week 1 to Week 2(2 Weeks)
- Pre-intervention Mean Bacterial Load(Pre-intervention, up to 3 weeks)
- Clinical Wound Assessment(Pre-intervention, up to 3 weeks)
- Follow up Clinical Wound Assessment(Follow Up, up to 4 weeks)
- Baseline Wound Fluid(Baseline, 1 Week)
- Patient Questionnaire(4 weeks)
- Mean time of Treatment Procedure(Post-intervention, up to 3 weeks)
- Common Terminology Criteria for Adverse Events, version 5.0, Nov 27, 2017 (CTCAE)(Follow Up, 4 weeks)
- Numeric Rating Scale (1-10)(Post-intervention, up to 3 weeks)
- Wong Baker FACES (1-10)(Post-intervention, up to 3 weeks)
- Baseline Mean Bacterial Load(1 week)
- Post-intervention Mean Bacterial Load(Post-intervention, up to 3 weeks)
- Mean Bacterial Load at Follow Up(Follow up, up to 4 weeks)
- Change from Baseline Wound Fluid Composition Week 1 to Week 3(3 Weeks)
- Change from Baseline Wound Fluid Composition Week 1 to Week 4(4 weeks)
- Baseline Wound Size Week 1(Baseline, week 1)
- Change from Baseline Wound Size Week 1 to Week 4(Follow Up, 4 weeks)
- Change from Baseline Wound Size Week 1 to Week 2(2 Weeks)
- Change from Baseline Wound Size Week 1 to Week 3(3 Weeks)
研究者
Frederik Plum
MD, Ph.D Fellow at University of Copenhagen
Bispebjerg Hospital