Foot hold

The future of diabetic ulcer care in a pivotal area

Despite rapid advances in diabetes care in recent years, one of its most catastrophic complications, diabetic foot ulcers (DFUs), remains a significant issue for both patients and healthcare systems, affecting an estimated 60 million people globally.

These wounds impose a substantial impact on patients’ quality of life by reducing mobility, the ability to work, and negatively affecting physical and mental well-being.

Most shockingly, the rate of diabetes-related amputations, which are the number one cause of lower-limb loss in the UK, continues to increase, directly impacting patients’ well-being and overall health, while consuming enormous healthcare resources and contributing to spiralling costs.

World Diabetes Day – marked annually in November – is a chance to highlight the many challenges faced by people with diabetes around the world.

An ongoing focus for World Diabetes Day is access to patient care, while one of the key themes for the 2023 campaign was the impact of diabetes-related complications.

Indeed, last year’s World Diabetes Day presented a great opportunity to raise awareness of the substantial unmet need for more effective and durable treatments for DFUs and to highlight the health inequities that exist for many who are in dire need of such care.

Due to both the peripheral neuropathy and ischaemia caused by diabetes, DFUs are extremely difficult to heal, frequently leading to lower-limb amputations.

In the US alone, a person with diabetes has a limb amputated every three minutes and 30 seconds, and globally, 80% of leg amputations are caused by diabetes complications.

The five-year mortality rate for diabetic foot ulcers is comparable to that of all causes of cancer, while the mortality rate increases further in the case of amputation.

Importantly, up to 85% of these amputations could be avoided if the DFUs were treated and healed before progressing too far.

This highlights the importance of early access to care and effective treatment modalities, which unfortunately remains a considerable issue, particularly for low-income and minority communities.

According to the Amputation Prevention Alliance of the American Diabetes Association (ADA), minorities in the US have up to four times the likelihood of experiencing a diabetes-related amputation than their white counterparts.

Diabetes is a growing pandemic that afflicts over 537 million people globally, with a third likely to develop a DFU in their lifetime.

In addition to the significant challenges for both patients and their families, the treatment of DFUs has a substantial impact on healthcare systems around the world.  The cost of diabetic foot care in the US is comparable to the approximately $80bn spent on cancer treatments. One of the key challenges in the treatment of DFUs – both for patients and healthcare systems – is the time it takes to heal the wounds and the alarming rate of reoccurrence.

Studies have shown that 66% of DFUs take longer than a year to heal and then 40% reoccur at one year, increasing to 65% at five years.

Access to care that can provide a fast, long-term healing treatments for these wounds is therefore vital to address this issue

Oxygen is vital for healing chronic wounds that are fundamentally hypoxic.

This means tissue oxygen levels have fallen below the required levels to fight infection and stimulate tissue repair through the upregulation of enzymes responsible for the healing cascade and cellular metabolism.

The use of oxygen for the treatment of DFUs therefore has great potential to significantly improve long-term treatment outcomes for patients around the world.

Although the benefits of oxygen in wound healing are well-established, for a long time, finding the most effective way to apply adequate amounts of oxygen directly to the wound site, without unwanted systemic side effects, remained a challenge.

At AOTI, we have developed a patient-applied, at-home therapy that addresses these issues.

The use of cyclical-pressure Topical Wound Oxygen (TWO2) therapy has opened up new opportunities in the durable treatment of DFUs and other chronic wounds, such as venous leg ulcers and pressure ulcers, through the multimodality delivery of oxygen directly to the wound site.

The greater oxygen pressure and non-contact cyclical compression delivered with TWO2 provides several benefits in the treatment of all chronic wounds.

They include the stimulation of the localised immune response to infection, reduction of oedema, aiding the passage of nutrients to wounded tissue, the movement of blood and lymphatic fluids, and accelerated elimination of metabolites.

State-of-the-art randomised clinical trials have suggested that DFUs receiving this treatment are six times more likely to heal within 12 weeks and incredibly, due to the quality of healing, are six times less likely to reoccur at 12 months.

Additionally, a large real-world evidence study on very comorbid patients in the US demonstrated that this more durable healing resulted in an 88% reduction in hospitalisations and 71% reduction in amputations at 12 months.

An additional advantage of this technology is the ability for patients to self-administer the treatment within their own homes for just 90 mins, five days a week.

This alleviates the burden and cost of travelling to treatment sites, which gives patients more freedom in the application of the treatment, and further reduces the cost and impact on healthcare systems.

The convenience of at-home treatments for patients also increases treatment compliance – therefore improving treatment outcomes – and significantly improves access to care for those who may not be able to travel.

The success and body of evidence for this new treatment option is so significant that the American Diabetes Association and the International Working Group on the Diabetic Foot now recommend adjunctive topical oxygen to their standard of care in the treatment of DFUs.

In December, the Wound Healing Society also gave topical oxygen its highest ‘level 1’ adjunctive treatment recommendation in its 2023 DFU treatment guidelines.

Amid growing rates of diabetes around the world, life-changing secondary complications such as DFUs are becoming an increasingly critical issue for patients and healthcare systems alike.

We are in the midst of a lower limb amputation pandemic, which is having a significant impact on patients and their quality of life.

As with many chronic diseases, there are disparities in access to care and glaring health inequalities exist. Those who are most affected are often least able to access care. Therefore, access to new at-home treatments that reduce the burden on both patients and healthcare systems is important to address these issues.

Cyclical-pressure topical wound oxygen therapy has the potential to revolutionise the treatment of chronic wounds and improve the quality of life for patients while also reducing the burden and costs on healthcare systems across the world.

Dr Mike Griffiths is Chief Executive Officer at AOTI. Go to aotinc.net