Intermittent Negative Pressure for Patients With Diabetic Foot Ulcers (INPRESS) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in wound surface area
研究概览
简要总结
The aim of this trial is to investigate the safety and efficacy of 12 weeks treatment with FlowOx, for 1 hour twice daily, when used on patients with diabetic foot ulcers. The main question it aims to answer is whether treatment with FlowOx one hour in the morning and one hour in the evening for 12 weeks can improve toe arterial pressure and wound surface area compared to baseline.
Participants will have baseline assessments (i.e. toe pressure measurement and wound area measurement) performed on them and training on the use of FlowOx device will be provided to them in Visit 1. Participants will be tasked to use the FlowOx device (device will be loaned to them) for 1 hour twice daily. A phone call will be conducted 1 week after Visit 1 to follow up on the medical and user-related issues. At Week 6 (Visit 2), participants will be asked to come back for toe pressure and wound area measurement. At Week 12 (Visit 3), end of treatment assessments (i.e toe pressure and wound area measurement) will be performed. Compliance data will be acquired from the FlowOx device.
Their participation in the study will last for 12 weeks. Participants will be asked to use the FlowOx device for one hour, two times a day throughout the study period. They will need to visit the clinic 3 times in the course of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 99 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 21-
- •Diagnosed with diabetes mellitus.
- •Toe systolic pressure <90 mmHg on the leg to be treated (after revascularization)
- •Open chronic wound on the foot
- •Ability to operate the treatment device, and willing to adhere to the study intervention regimen.
- •Suitable for diabetic limb salvage
排除标准
- •Known allergic reactions to components of the INP device.
- •Treatment with another investigational intervention within the last 12 weeks prior to inclusion.
- •Pregnant women or cognitively impaired participants.
研究组 & 干预措施
Treatment with FlowOx
干预措施: FlowOx (Device)
结局指标
主要结局
Change in wound surface area
时间窗: 12 weeks
Change in wound surface area will be used as an indicator of treatment effect on wound healing. * Tool used: quantitative measurement of wound surface area * Unit of measure: cm2
Change in toe arterial pressure
时间窗: 12 weeks
Toe systolic blood pressure is a commonly used tool to predict wound healing in patients with diabetic foot ulcers. * Tools used: Photoplethysmography (PPG) Probe/Sensor * Unit of measure: mmHg
次要结局
- Comparison of the primary outcomes (changes in toe arterial pressure and wound healing rate) and post diabetic limb salvage rate between a prospective cohort that is 1:1 propensity-scored matched against a retrospective cohort(12 weeks)
- Frequency of adverse events(12 weeks)
- Compliance (mean daily treatment time)(12 weeks)
研究者
Lo Zhiwen Joseph
Senior Consultant
Woodlands Health Campus