Identification of Biomarkers, Prognostic Indicators and Development of Novel Interface Devices for the Clinical Use of Topical Negative Pressure in Diabetic Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Wound closure
研究概览
简要总结
Topical Negative Pressure Wound Therapy (TNPW) is an established tool in the management of Diabetic foot ulcer in many countries. This treatment option is under utilized in the public sector of Mauritius. This study aims to determine the efficacy of TNPW through identification of biomarkers in the Mauritian setting compared with conventional treatment. Patient with DFU will be selected based on an eligible criteria and randomly assigned to intervention group or control group.
Primary Objective: To determine the efficacy of TNPW in the public sector in Mauritius Secondary Objectives: To compare healing times, prognostic factors skin biopsies based on biomarker, histological and genomic analysis A randomised controlled study is being proposed, where up to 100 participants will be recruited.
The wounds of participants in the intervention arm will be managed with 3 weeks of TNPW.
详细描述
Study Description: Topical Negative Pressure Wound Therapy (TNPW) is an established tool in the management of Diabetic foot ulcer in many countries. This treatment option is under utilized in the public sector of Mauritius. This study aims to determine the efficacy of TNPW through identification of biomarkers in the Mauritian setting compared with conventional treatment
Objectives:
Primary Objective: To determine the efficacy of TNPW in the public sector in Mauritius Secondary Objectives: To compare healing times, prognostic factors skin biopsies based on biomarker, histological and genomic analysis
Endpoints:
Primary Endpoint:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 18 - 75 years
- •In good general health as evidenced by medical history or diagnosed with diabetes mellitus or exhibiting signs of diabetic foot ulcers
- •Patients suffering from diabetic foot ulcer last more than 3 weeks
- •Patients with diabetes and presence of a foot wound for more than 3 weeks
排除标准
- •Patients under <18 years or above 75 years
- •Patients unable to provide consent
- •Patients suffering from chronic kidney disease or liver impairment or other chronic conditions
- •Patients on anticoagulants
- •Patients with non diabetic ulcers
- •Patients with severe peripheral vascular disease
- •Patients having contra-indication to negative pressure wound therapy
结局指标
主要结局
Wound closure
时间窗: 3 weeks
Any wound closure or % reduction in size
次要结局
- complete wound closure(1 year)
- Biomarkers(3 weeks)
- Adverse events(1 year)
研究者
Archana BHAW LUXIMON
Professor
University of Mauritius