Active not recruitingNAINTERVENTIONAL

Extracorporeal Shockwave Therapy for Diabetic Foot Ulcers

Diabetes can cause foot sores that are hard to heal, sometimes leading to serious problems like amputations. This study is exploring a new treatment called shockwave therapy, which uses powerful sound waves similar to ultrasound, to see if it can help these sores heal more effectively. We know how important it is to find better treatments that are safe, work well, and are affordable for the NHS. This research will test different strengths of shockwave therapy against a dummy treatment to understand if it truly helps the sores heal faster. We'll also talk to patients and doctors to understand their thoughts and experiences with this new approach, and check if it's a cost-effective solution.

At a glance

Status

Active not recruiting

Phase

Sponsor

Hull University Teaching Hospitals NHS Trust

Enrolment target

Start

13 Apr 2022

Estimated completion

01 May 2032

Diabetic Foot

What is this study about?

Many people with diabetes can develop foot sores, also known as ulcers, which can be very difficult to heal. Even with the best current medical care, these sores can take a long time to get better, and sometimes they don't heal at all. Sadly, this can lead to serious consequences, impacting daily life, work, and even requiring amputations in severe cases. This is why finding new and better ways to treat these foot sores is so important.

Our research is focused on a new treatment called extracorporeal shockwave therapy. This therapy uses high-power sound waves, similar to the ones used in ultrasound, and delivers them directly to the sore. The idea is that these sound waves might help the sores heal more quickly. While this treatment shows promise, we don't yet know how effective it really is or what the best strength (or 'dose') of the treatment is to help people. This study aims to answer those questions.

We're conducting a pilot study, which is like a small-scale trial, to compare how well different strengths of shockwave therapy work. We'll also be using a 'sham' treatment, which means it looks and feels like the real treatment but doesn't actually deliver the sound waves. This helps us ensure that any improvements we see are indeed due to the shockwave therapy itself and not just other factors. We'll also be talking to patients and doctors to understand their feelings and experiences with this new approach, and we'll be looking into whether it offers good value for money for the NHS.

Key takeaways

Diabetic foot sores are a big problem and new treatments are urgently needed.
Shockwave therapy uses sound waves to potentially help these sores heal.
This study compares different strengths of shockwave therapy and a 'sham' treatment.
Participation involves short treatment sessions and follow-up checks over six months.
We also want to understand patient and doctor opinions on this new therapy.
The study aims to see if shockwave therapy is effective and good value for money.

Who may be eligible?

To be considered for this study, you would need to have at least one foot sore below your ankle that has been present for more than four weeks and hasn't healed. Your circulation in your foot also needs to be at a certain level.

There are some reasons why you wouldn't be able to join. For example, if your sore is between your toes, or if you are pregnant, trying to get pregnant, or breastfeeding. Also, if you have certain types of cancer, are taking blood-thinning medicines, or have an active bone infection (osteomyelitis), you wouldn't be able to take part. It's also not suitable if you're already in another research study that might affect the results of this one.

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.

Do I have a diabetic foot sore that’s been there for over four weeks and hasn't healed?
Is my foot sore below my ankle?
Am I NOT pregnant, breastfeeding, or trying to conceive?
Am I NOT taking blood-thinning medications or being treated for a bone infection?
Do I NOT have cancer in the treatment area or certain other types of cancer?
Am I willing to have my sore photographed and attend follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly put into one of three groups: one group will receive a high strength of shockwave treatment, another will get a low strength, and the third group will receive a 'sham' treatment, which will feel similar but won't deliver the active sound waves. You won't know which group you are in, and neither will the person collecting information about your wound.

Each treatment involves three sessions, with each session lasting about 30 minutes, all taking place within a week. After your treatment, you'll have follow-up appointments at 1, 2, 3, and 6 months to check how your foot sore is healing and how your quality of life is changing. We might also ask to take pictures of your sore. We will also invite some participants for an interview, to learn about your experiences and thoughts on the shockwave therapy and taking part in the study.

Potential risks and benefits

Participating in this study might offer the potential benefit of your diabetic foot sore healing faster, which could improve your quality of life. However, as with any new treatment, there could be some unknown risks or side effects, although shockwave therapy is generally considered safe. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

Hull University Teaching Hospitals NHS Trust
Verified postcode
Hull, United Kingdom

Common questions

What is shockwave therapy?

It's a treatment that uses powerful sound waves, similar to ultrasound, to try and help foot sores heal.

Will I know if I'm getting the real treatment?

No, you won't know if you're getting the active shockwave treatment or the 'sham' treatment. This helps us get accurate results.

How long will the treatment sessions be?

Each treatment session will last about 30 minutes, and you will have three sessions within a week.

What happens after the treatment?

You'll have follow-up appointments at 1, 2, 3, and 6 months to check on your sore and how you're feeling.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, without it affecting your medical care.