Addressing the silent killer:
Revolutionising diabetic foot ulcer healing with shockwave therapy

Applying gel to foot ulcer shockwave therapy machine
"The sobering reality is that the five-year mortality rate associated with diabetic foot complications surpasses even that of cancer; This silent killer demands our immediate attention"
Ms Louise Hitchman

Diabetic foot ulcers are not just wounds on the foot; they serve as a stark marker of an advanced stage of disease.

Now, a ground-breaking research project named SOLEFUL, is investigating shockwave therapy as a means to enhance the healing of diabetic foot ulcers. The study, funded by the National Institute for Health Research (NIHR) and Diabetes UK, aims to shed light on the optimal use of shockwave therapy in the NHS.

The driving force behind this research is Ms Louise Hitchman, a Vascular Registrar at Hull University Teaching Hospitals NHS Trust and NIHR Doctoral Research Fellow in the Clinical Sciences Centre at Hull York Medical School, who has witnessed the challenges faced by patients with diabetic foot ulcers.

Ms Louise Hitchman

Ms Louise Hitchman, a Vascular Registrar at Hull University Teaching Hospitals NHS Trust and NIHR Doctoral Research Fellow in the Clinical Sciences Centre at Hull York Medical School

Ms Louise Hitchman, a Vascular Registrar at Hull University Teaching Hospitals NHS Trust and NIHR Doctoral Research Fellow in the Clinical Sciences Centre at Hull York Medical School

Her motivation stems from a desire to improve wound care, an area that has seen limited advancements compared to other fields, such as cancer research.

Ms Hitchman said, "These ulcers are often perceived as just a wound on the foot; however, that is not the case. It’s a marker of global poor health.

"Diabetic foot ulcers are often overlooked and underestimated, despite their substantial impact on patient’s outcomes and their quality of life"
Ms Louise Hitchman

"There is sparse high-quality research around interventions to improve diabetic foot ulcers healing. This research aims to address this critical gap in wound care."

The significance of this research cannot be overstated. An estimated 4.9 million people in the UK have diabetes (1), and diabetic foot ulcers affect 25% of those individuals. Over 50% of these ulcers don't heal within one year, which predisposes individuals to get infections which could lead to major lower limb amputations. (2) Alarmingly, the five-year mortality rate following a major lower limb amputation is higher than that of all cancers.

Shockwave therapy, the focus of this study, is the use of high-frequency sound waves to stimulate healing in the wound. The therapy induces cellular vibrations, resembling a controlled local inflammation, triggering the release of chemicals that promote cell formation and blood vessel growth, ultimately aiding in wound healing.

By shining a spotlight on diabetic foot ulcers and the transformative potential of shockwave therapy, Ms Hitchman aims to improve wound care and transform the lives of millions impacted by this silent and often overlooked health issue.

Exploring shockwave therapy's feasibility, optimal dosage, and patient impact

The research team conducted a small-scale cohort study, examining the feasibility of shockwave therapy in the NHS. The review, published in the Journal of Wound Care, yielded promising results, demonstrating the tolerability and acceptability of shockwave therapy for patients. Furthermore, a systematic review, published in the International Wound Journal, showcased the potential effectiveness of shockwave therapy.

However, one of the main challenges lies in determining the optimal dosage for shockwave therapy for diabetic foot ulcers. To address this, the team collaborated with Professor Mat Hardman, Director of Research (Hull) and Chair in Wound Healing in the Biomedical Institute for Multimorbidity at Hull York Medical School, to conduct laboratory experiments sponsored by the NIHR MedTech program.

Through their experiments, they discovered that increasing the number of shocks delivered led to faster wound size reduction and an upsurge in the expression of vascular endothelial growth factor (VEGF), crucial for new blood vessel growth.

To investigate the impact of shockwave therapy on real patients, the Ms Hitchman is now conducting a pilot randomised control trial. The trial compares low-dose shockwave therapy (100 shocks per centimetre squared), high-dose shockwave therapy (500 shocks per centimetre squared), and a placebo shockwave therapy group acting as the control. The pilot trial aims to assess the scalability of conducting the research in a larger trial.

Alongside the trial, the Ms Hitchman is conducting qualitative interviews to gain insights into the experiences of trial participants and clinicians. They seek to understand patient experiences, clinician perspectives on shockwave therapy, reasons for dropouts, and factors contributing to potential trial non-participation.

"When someone has a diabetic foot ulcer, people cannot walk on it, they can be in pain, and it has a huge impact on their quality of life"
Ms Louise Hitchman

Ms Hitchman explained, "Many people have to take long periods of time off work or give up their jobs entirely. It can have a huge impact on their finances and relationships. This is another reason why our research is so important – so we can improve people’s quality of life."

Ms Hitchman said of the qualitative interviews with patients, "Many patients have told us they appreciate the holistic approach and personalised care provided throughout the study.

"The support, including regular check-ins and personalised questionnaires, has fostered a sense of benefit and reassurance among participants."

Diabetic foot ulcer shockwave therapy machine

Paving the way for expanded research and clinical effectiveness of shockwave therapy

Following the completion of the trial, Ms Hitchman will undertake an economic evaluation to estimate the cost-effectiveness of shockwave therapy compared to standard care. By incorporating the trial results and existing literature, they will build a cost-effectiveness model and perform a sensitivity analysis. This analysis will help identify areas of uncertainty and guide future research to on the cost-effectiveness of the intervention.

The study is also supported by the Vascular Society’s Diabetic Foot Research Special Interest Group Collaboration, which includes a multitude of different healthcare professionals, academics and vascular surgeons throughout the UK, further enhancing the study's potential for success.

Ms Hitchman anticipates that the trial will prove scalable and provide valuable insights into the effectiveness of shockwave therapy. She hopes that this will lead to a larger, multicentre trial, and to continue to research why shockwave therapy if effective, as well as the clinical effectiveness.

Ms Hitchman said, “I would like to thank my supervisors Professor Ian Chetter, Associate Professor David Russell, Dr Maureen Twiddy and Professor Cynthia Iglesias for their support in this research. I hope the output from this programme of research will contribute to the continuing improvements in diabetic foot ulcer care and I look forward to sharing the results when available.”

For more information about this research, contact Ms Louise Hitchman, NIHR Doctoral Research Fellow in the Clinical Sciences Centre.

References

(1) How many people in the UK have diabetes? Diabetes UK

(2) Armstrong, D.G., Swerdlow, M.A., Armstrong, A.A. et al. Five year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer. J Foot Ankle Res13, 16 (2020). https://doi.org/10.1186/s13047-020-00383-2