Path Active Multicentre Randomised Controlled Trial (Previous Pilot: Path Active; Safety and Tolerability Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Device questionnaire
研究概览
简要总结
Path Active™ comprises a pair of monitoring insoles which measure parameters associated with foot ulceration in diabetes: temperature and pressure. The insoles are linked via an app to the wearer's mobile phone and also to a clinical dashboard so that both wearer and clinician are alerted to early signs of skin damage on the foot so that immediate preventive action can be taken. The study is a multisite randomised controlled trial which will evaluate the effectiveness of Path Active™ in 60 people with diabetes who are at 'high risk' of foot ulceration, compared with 60 people who receive their usual podiatry foot checks over a period of 12 weeks.
详细描述
Foot complications in people with diabetes are the most common cause of non-traumatic leg amputation in the UK with over 176 leg, toe or foot amputations every week in England. One in seven people with diabetes will develop a foot ulcer at some stage in their lives. Not only does this impair their daily activities and reduce their quality of life, it also increases their risk of amputation by up to 24-fold. Five year mortality for minor and major amputations in diabetes have been reported as 46.2% and 56.6%, respectively. Circulatory problems, nerve impairment and infection contribute to foot complications in diabetes. Prior to a foot ulceration, changes in temperature and/or pressure occur. These early warning signs can be measured by Path Active™ and alert the wearer via a mobile phone app and the clinician via a clinical dashboard so that preventive action can be taken. Currently people with diabetes who have been assessed as 'high risk' for foot ulceration are allocated appointments with podiatrists in 'foot protection teams' who review on a weekly to monthly basis. Path Active™ has the potential to reduce appointments by alerting podiatry teams to potential problems as they occur rather than regular routine reviews. Path Active™ may be able to reduce hospital and clinic visits and thereby reduce healthcare carbon footprint.
The primary objective of this clinical investigation is to evaluate the effectiveness of Path Active™ in people with diabetes who are at 'high risk' of foot ulceration. The study is a multisite randomised controlled trial which will evaluate the effectiveness of Path Active™ in 60 people with diabetes who are at 'high risk' of foot ulceration, compared with 60 people who receive their usual podiatry foot checks over a period of 12 weeks. Recruitment to the study will be in 4 clinical sites across England and Scotland.
The protocol for this study was amended from the pilot study and accepted as a 'major amendment' by the regional Ethics Committee of Essex. Therefore the IRAS number (Unique Protocol ID: 326601) has remained the same.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
盲法说明
The participants will be randomised (using 'sealed envelope') to either 'care as usual' or 'use of device'.
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Participant able to give informed consent.
- •Age >18 at the time of consent.
- •Diagnosis of Type 1 or Type 2 Diabetes.
- •Both Feet Intact (no ulceration).
- •Participant understands and is willing to participate and can comply with the follow-up regime.
- •Participant diabetes foot Risk Stratification as 'High Risk' as in Frame (2021) Scotland/England https://www.diabetesframe.org/
- •Ability to walk independently for > 100 metres i.e without use of wheelchair, walking stick or personal assistance.
- •Participant able and willing to wear suitable footwear.
- •Must own a mobile phone and be willing to upload WWP app.
排除标准
- •Either foot has less than 2 arterial vessel run-off on Doppler.
- •Poor visual acuity ie registered blind, unless supported by carer.
- •Current participation in another clinical investigation of a medical device or a drug; or participation in such a study within 30 days prior to study enrolment.
- •Body Mass Index (BMI) >
- •Participant has bespoke contact insoles and footwear.
- •Participant is unable to use 'medium' or 'large' insoles due to foot size eg. small or extra large feet.
- •Participant has a pacemaker.
- •Participant is pregnant.
结局指标
主要结局
Device questionnaire
时间窗: 6 months (Participants will wear the device for a minimum of 12 weeks)
Participants in the 'Path Active' arm will complete study questionnaires relating to the product (ease of use, use of the mobile phone app, use of the insoles, action taken relating to app warnings).
Control Group questionnaire
时间窗: 6 months
Participants in the 'Control Group' arm will complete study questionnaires relating to their usual care (how often do you see a healthcare professional for foot checks, how often do you examine your feet, how concerned are you about developing a foot ulcer etc)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
时间窗: 6 months (Participants will wear the device for a minimum of 7 days)
The primary objective of this clinical investigation is to evaluate the effectiveness of Path Active™ in people with diabetes who are at 'high risk' of foot ulceration.
Changes Quality of Life Measurement
时间窗: 6 months (Participants will wear the device for a minimum of 12 weeks)
EuroQol EQ-5D-5L assessment for quality of life assessment at the beginning and end of the study period. The EQ-5D-5L health profile includes the items mobility (MO), self-care (SC), usual activities (UA), pain/discomfort (PD) and anxiety/depression (AD). The EQ-5D-5L asks respondents to endorse one of five response levels for each item: "no problems," "slight problems," "moderate problems," "severe problems," and "extreme problems"/ "unable to", describing 3125 (55) health state profiles. The instrument also includes a visual analog scale (VAS) anchored by 0 (worst imaginable health) and 100 (best imaginable health) that will be analysed separately from the health profile.
次要结局
- Reduction in CO2 comparing carbon dioxide emitted due to ulcer treatment vs carbon dioxide emitted due to device manufacture(6 months (Participants will wear the device for a minimum of 12 weeks))
研究者
Richard Leigh
Chief Investigator
Royal Free Hospital NHS Foundation Trust