AuthorisedTherapeutic exploratory (Phase II)Interventional

A randomized, double-blind, placebo-controlled study to assess the effects of high concentration capsaicin patch (Qutenza) on neuropathic symptoms, nerve fibers, and microcirculation in painful diabetic peripheral neuropathy

This research is investigating a patch treatment for painful diabetic peripheral neuropathy, a condition where people with diabetes experience ongoing nerve pain, often in their feet and legs. The study aims to find out if a special patch called Qutenza, which contains a high concentration of capsaicin (found in chilli peppers), can help relieve this pain and even improve the health of tiny nerve fibres and blood circulation in the affected areas. Participants will receive either the Qutenza patch or a dummy patch, and researchers will carefully compare the effects. The main focus is on how nerve fibres change over time with repeated treatment. Researchers will also look at pain levels, quality of life, and any side effects. This is a Phase II study, meaning it's an early-stage trial exploring the treatment's effectiveness.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Deutsche Diabetes Forschungsgesellschaft e.V.

Enrolment target

Start

20 Jan 2026

Painful diabetic peripheral neuropathy

What is this study about?

If you have diabetes, you might know that over time, high blood sugar can damage nerves, especially in your hands and feet. This is called diabetic peripheral neuropathy. Sometimes, this nerve damage can be very painful, affecting daily life. Doctors and scientists are always looking for better ways to help people manage this pain.

This particular study is focusing on a special patch called Qutenza. This patch contains a high amount of capsaicin, which is the natural chemical that makes chilli peppers hot. When applied to the skin, capsaicin can help to calm overactive pain signals in the nerves. Researchers want to see if using this patch can not only reduce pain but also help to improve the health of the very tiny nerve fibres under your skin and the blood flow in those areas.

To make sure the results are reliable, some participants will receive the actual Qutenza patch, and others will receive a 'dummy' patch that looks the same but doesn't contain the active ingredient. Neither you nor your doctor will know which patch you're receiving – this is called a 'double-blind' study. By comparing the groups, the researchers can better understand the true effects of the Qutenza patch on your pain, how your nerves are doing, and even how it affects your quality of life.

Key takeaways

The study is for painful diabetic nerve damage.
It tests a patch called Qutenza, which uses a chilli pepper chemical.
Researchers want to see if it reduces pain and improves nerve health.
Some participants will get the actual patch, others a dummy patch.
It's an early-stage study to explore the treatment's effects.

Who may be eligible?

This study is looking for adults aged 18 and over, of any gender. You would need to have been diagnosed with painful diabetic peripheral neuropathy, which means you experience nerve pain as a result of your diabetes.

There might be other specific health conditions or medications that would prevent someone from joining the study, as researchers need to ensure it's safe for everyone involved and that the results aren't affected by other factors. Your doctor or the study team would go through a full list of these criteria with you.

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 18 years old or older?
Do you have diabetes?
Do you experience ongoing nerve pain because of your diabetes?
Are you able to attend regular clinic visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to receive either the active Qutenza patch or a dummy patch. You'll visit the study clinic for regular check-ups over several months. This will involve having the patch applied to the painful areas of your skin.

Throughout the study, you'll be asked to provide information about your pain levels and how you're feeling using questionnaires. Researchers will also take small skin samples (called biopsies) to look closely at your nerve fibres and blood vessels, and they might do other tests to check your nerve function and blood flow. These visits will help the research team understand how the treatment is affecting you. The total duration of the study would be discussed with you by the research team.

Potential risks and benefits

Taking part in any clinical study has potential benefits and risks. You might benefit from the treatment if the Qutenza patch helps reduce your pain. Even if you receive the dummy patch, you'll get regular medical attention for your condition. However, there's no guarantee the treatment will work for you, and you might experience side effects from the patch or discomfort from the tests, like the skin biopsies. Common side effects with capsaicin patches can include temporary redness or burning where the patch was applied. 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.

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Unverified
Germany

Common questions

What is painful diabetic peripheral neuropathy?

It's a type of nerve pain that can occur in people with diabetes, often affecting the feet and legs, caused by high blood sugar damaging nerves.

What is Qutenza?

Qutenza is a skin patch that contains a high concentration of capsaicin, a natural substance found in chilli peppers, which can help calm overactive nerve signals that cause pain.

What does 'double-blind' mean?

It means neither you nor your study doctor will know whether you're receiving the active Qutenza patch or a dummy patch. This helps ensure the study results are fair.

What is a skin biopsy?

It's a very small sample of skin taken from the treatment area. It helps researchers look at your nerve fibres and blood vessels under a microscope.

How long will the study last?

The study involves regular treatments and check-ups over several months, with the main assessment happening at 35 weeks (about 8 months), but the overall duration may be longer.