RecruitingNAINTERVENTIONAL

Path Active Multicentre Randomised Controlled Trial (Previous Pilot: Path Active; Safety and Tolerability Study)

This study is investigating a new type of smart insole called Path Active™ for people with diabetes who are at high risk of developing foot ulcers. These insoles are designed to measure key signs, like changes in foot temperature and pressure, that can warn of potential skin damage before an ulcer forms. The information is sent to a mobile phone app for the wearer and a dashboard for their healthcare team, allowing for quick action to prevent problems. This research will compare the effectiveness of using Path Active™ insoles with receiving standard foot checks from a podiatrist. We will follow 120 participants over 12 weeks to see if Path Active™ can help reduce the risk of foot ulcers and potentially lead to fewer hospital visits.

At a glance

Status

Recruiting

Phase

Sponsor

Royal Free Hospital NHS Foundation Trust

Enrolment target

120

Start

02 Apr 2024

Estimated completion

31 Mar 2026

Diabetic Foot

What is this study about?

Foot problems are a serious concern for people with diabetes, and they are unfortunately the most common reason for leg, foot, or toe amputations in the UK that aren't caused by accidents. In fact, more than 176 such amputations happen every week in England. One in seven people with diabetes will experience a foot ulcer at some point in their lives. These ulcers can severely impact daily activities and quality of life, and dramatically increase the risk of amputation. Sadly, the outlook after an amputation can be very poor, with many people not surviving beyond five years.

Foot ulcers often develop due to problems with circulation, nerve damage, and infections. Before an ulcer actually forms, there are usually subtle changes in the foot's temperature or pressure. This is where Path Active™ comes in. It's a pair of smart insoles designed to detect these early warning signs. The insoles are connected to a mobile phone app for the user and a special dashboard for their healthcare team. If the insoles detect worrying changes, both the user and their healthcare team are alerted, so they can take immediate steps to prevent an ulcer from developing.

Currently, people with diabetes who are considered at 'high risk' of foot ulcers have regular appointments with podiatrists (foot specialists) – sometimes weekly, sometimes monthly. The idea behind Path Active™ is that it could help reduce the need for so many routine appointments. Instead, the podiatry team would only be alerted when a potential problem arises. This could not only potentially reduce hospital and clinic visits for patients but also help to lessen the healthcare system's environmental impact.

Key takeaways

Tests smart insoles designed to prevent foot ulcers in people with diabetes.
Monitors foot temperature and pressure, alerting users and doctors to issues.
Compares smart insoles to standard podiatry care over 12 weeks.
Aims to reduce foot ulcers and potentially hospital visits.
Recruiting people with diabetes at high risk of foot ulcers.

Who may be eligible?

To join this study, you must be over 18 years old and have been diagnosed with either Type 1 or Type 2 diabetes. All parts of both your feet must be intact, meaning you don't currently have any open sores or ulcers. You should be able to walk on your own for more than 100 metres (which is about the length of a football pitch) without needing a wheelchair, walking stick, or someone to help you. You also need to own a mobile phone and be willing to download an app on it.

We are specifically looking for people who have been identified by their healthcare team as being at 'high risk' of developing foot ulcers according to national guidelines for diabetes foot care. You must be willing to wear appropriate footwear and be able to use the study insoles, which come in medium and large sizes. We'll also need you to understand what the study involves, agree to take part, and be able to attend follow-up appointments.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you over 18 and have Type 1 or Type 2 diabetes?
Do you currently have no open sores or ulcers on your feet?
Can you walk independently for more than 100 metres?
Do you own a mobile phone and are willing to use an app?
Have you been told you are at 'high risk' of foot ulcers?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be in one of two groups. One group will use the Path Active™ smart insoles, and the other will continue to receive their usual foot care from a podiatrist. Which group you are in will be decided randomly, like flipping a coin. Both groups will be followed for a period of 12 weeks. Throughout this time, you'll have appointments to check on your feet and how you're feeling. For those using the insoles, you'll need to wear them and upload information via a mobile phone app. The total duration of your participation in the study, including all follow-up, will be 12 weeks. There are no study medications involved; this study is about a medical device.

Potential risks and benefits

Taking part in this study could offer several potential benefits. If you are in the group using the Path Active™ insoles, you might experience earlier detection of potential foot problems, which could help prevent ulcers from forming. This could lead to better foot health and a potentially improved quality of life. For everyone involved, you'll receive regular monitoring of your foot health. As with any study, there are potential risks, although these are generally low. For example, wearing the insoles might cause minor discomfort for some, or there could be technical issues with the app. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Royal Free Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is a 'diabetic foot ulcer'?

A diabetic foot ulcer is an open sore or wound on the foot that can be very common in people with diabetes. They can be serious if not treated properly.

What are Path Active™ insoles?

Path Active™ insoles are smart shoe inserts that measure foot temperature and pressure. These measurements help detect early signs of potential skin damage before an ulcer develops.

How does the study work?

The study compares using Path Active™ insoles with standard foot care over 12 weeks. You'll be randomly assigned to one of these two groups.

Will I still see my doctor or podiatrist?

Yes, you will continue to receive medical care from your usual healthcare team, and you will have appointments as part of the study to monitor your foot health.

What if I have an emergency during the study?

You should always contact your regular healthcare provider or emergency services for any medical emergency, just as you normally would.

How to find out more

Richard Leigh, BSc

richardleigh1@nhs.net +44208302749 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.