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Extracorporeal shockwave therapy: Hope for hard to heal ulcers

By Louise Hitchman, NIHR Doctoral Research Fellow at Hull York Medical School

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Researchers at the Hull York Medical School are developing an innovative treatment using soundwaves to heal diabetic foot ulcers.

Diabetic foot ulcers are notoriously challenging to treat and often deteriorate which can lead to amputations.

By helping ulcers heal faster legs and lives could be saved.

Shockwave Therapy

Shockwave therapy is a non-invasive and low risk procedure.

The treatment involves delivering low energy soundwaves onto the ulcer bed via a gel paddle.

The treatment takes less than 10 minutes and most people with diabetic foot ulcers cannot feel the soundwaves. This means that people generally find it an acceptable and tolerable treatment.

A recent review of shockwave therapy found that diabetic foot ulcers treated with shockwave healed four weeks sooner than ulcers treated with standard care.

While this could revolutionise diabetic foot ulcer treatment, introducing shockwave therapy into routine care has challenges.

Louise Hitchman

One of these challenges is deciding the best way to deliver the shockwave therapy.

Previous shockwave studies have used a range of doses and given the treatment over different time periods.

This means the most beneficial number of shocks to give and how often shockwave therapy should be given is unknown.

The SOLEFUL (Extracorporeal Shockwave Therapy for Diabetic Foot Ulcers) study aims to address this.

The Study

Our laboratory based work revealed the most beneficial number of shockwaves to induce cell replication and promote blood vessel growth.

While this is exciting in a laboratory setting, we are now exploring this in patients.

Firstly, we involved a group of patients with diabetic foot ulcers and their carers to design the study.

The group decided it was important to confirm the best dose (number of soundwaves) before exploring how often shockwave therapy should be given.

This is because people with diabetic foot ulcers often have other health problems and lots of healthcare appointments, so would like fewer appointments.

We are now taking this work forward in a National Institute of Health and Social Care funded pilot trial.

The trial is comparing low dose, high dose and placebo shockwave therapy in people with diabetic foot ulcers.

Our main outcome will be to determine whether our laboratory-identified shockwave treatment conditions lead to faster healing in patients.

Wound samples taken from patients will also be analysed to further understand how shockwave is promoting healing in patients.

A patient who completed the trial reported: ‘I think to get the treatment like that is quick, easy and painless, and it’s all done within a few minutes…I think it’s a good thing’.

Professor Mat Hardman, Hull York Medical Director of Research comments: “This is a fantastic example of how innovation can be applied to address a major area of unmet clinical need.

It is brilliant to see how MedTech research support is bringing such important patient benefit”.

Ultimately the results of the SOLEFUL project should demonstrate the mechanism of action of shockwave therapy, discover the optimum dose of shockwave therapy in people with diabetic foot ulcers and support the integration of this novel intervention into routine care.

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