Active not recruitingNAINTERVENTIONAL

Neuromuscular Electrical Stimulation For The Treatment of Diabetic Neuropathy

This study is investigating a new way to help people with nerve damage, called diabetic neuropathy, which is a common problem for those with diabetes. Many people experience symptoms like numbness, burning, or muscle weakness in their legs and feet, which can make daily activities difficult. We're testing a device called Revitive Medic Coach, which uses gentle electrical stimulation to encourage muscles to contract and might help improve nerve function. Currently, treatments mostly focus on preventing further damage and managing pain. This study wants to find out if this electrical stimulation device could offer another helpful, non-medication option for people living with this condition.

At a glance

Status

Active not recruiting

Phase

Sponsor

Imperial College London

Enrolment target

Start

22 Aug 2023

Estimated completion

30 Jun 2025

Diabetic Peripheral Neuropathy Diabetic Neuropathies Diabetic Polyneuropathy Diabetic Complication

What is this study about?

Diabetic neuropathy is a very common issue for people with diabetes, affecting almost half of them at some point. It happens when high blood sugar levels damage nerves, especially in the legs and feet. This can cause various uncomfortable symptoms, from a tingling or numb feeling to burning pain or extreme sensitivity. Some people might also find their muscles become weaker, making it harder to move around and do everyday things. In severe cases, it can even lead to more serious problems like foot ulcers, which are difficult to heal and can sometimes lead to amputation.

Currently, the main ways we help people with diabetic neuropathy are by trying to prevent it from getting worse and by managing the pain. This often involves carefully controlling blood sugar, eating healthily, and sometimes taking pain relief medication. However, there's always a need for new and different ways to help improve people's quality of life.

This study is exploring a different approach called Neuromuscular Electrical Stimulation (NMES). This involves using a small device, like the Revitive Medic Coach, to send gentle electrical pulses to the muscles and nerves. The idea is that these pulses can make the muscles contract softly and may directly stimulate the nerves, potentially helping them to work better. We want to see if using this device could improve the symptoms of diabetic neuropathy and make daily life easier for those affected.

Key takeaways

The study explores a device for nerve damage from diabetes.
It uses gentle electrical pulses to help muscles and nerves.
This is a non-medication approach for diabetic neuropathy.
Aims to improve comfort and movement in affected limbs.
Participants will use a Revitive Medic Coach device.

Who may be eligible?

To join this study, you need to be at least 18 years old – there's no upper age limit. You must have been diagnosed with either type 1 or type 2 diabetes by a doctor, and you also need to have a diagnosis of diabetic neuropathy.

We'll check for nerve damage using a special questionnaire called the Michigan Neuropathy Screening Instrument. You'll also need to have internet access at home, as the study involves using a Revitive app (we'll provide you with a smartphone for this).

However, some things would mean you can't take part. This includes if you are pregnant, have an electronic device implanted in your body (like a pacemaker), have another cause for your nerve problems that isn't diabetes, or currently have a foot ulcer. You also can't join if you have severe blood vessel disease that needs surgery, are being treated for (or have symptoms of) a deep vein clot, or if you've recently used a similar electrical stimulation device in the last year. We also need you to be able to understand and agree to take part in the study.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with type 1 or type 2 diabetes?
Have you been diagnosed with diabetic neuropathy?
Do you have internet access at home?
Are you pregnant or do you have an implanted electronic device?
Do you have a foot ulcer or severe vascular disease?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

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Potential risks and benefits

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Locations (1)

Imperial College London
London, United Kingdom

Common questions

What is diabetic neuropathy?

It's nerve damage caused by diabetes, often affecting the legs and feet, leading to symptoms like numbness, tingling, or pain.

What is Neuromuscular Electrical Stimulation (NMES)?

It's a treatment that uses gentle electrical pulses to stimulate muscles and nerves, aiming to help them function better.

Who is making the Revitive Medic Coach device?

The device is made by a company called Actegy Ltd.

Are there any age limits for joining?

You need to be at least 18 years old, but there's no upper age limit to participate.

Do I need internet access to join?

Yes, you need internet access at home because the study uses a special app. A smartphone will be provided for this.