An estimated 64,000 people in the UK suffer from diabetic foot ulceration – skin damage that can occur when a person with diabetes walks. The major cause is diabetic neuropathy, where high blood sugar levels cause damage to the nerves, a condition affecting some 40% of diabetes sufferers. The result can be a loss of feeling in the feet which in turn can mean that minor foot injuries are not noticed and addressed but instead develop into infections or ulcers.
Diabetic foot ulcers can lead to amputation and even death due to infection or sepsis. In addition, by limiting patient’s mobility it can exacerbate the risk of cardio-vascular disease. Some 50% of people with diabetic foot ulcers do not live beyond 5 years and around 85% of amputations are estimated to be the result of a diabetic foot ulcer.
Wearing insoles can help reduce the risk of developing foot ulcers, but they are beset by problems. First, patients often have to wait months for insoles. Second, the effectiveness of the insoles (their ‘offloading performance’) is difficult to predict and often ends up being evaluated using a ‘try it and see’ approach, resulting in further delays and increased risk before the patient finally receives insoles which are right for them. Third, many patients do not wear their insoles enough to be effective, and fourth there is the danger that the wrong type of insole could increase the risk of a fall, putting the patient in further danger. Addressing these four problems has been a key focus of the Institute’s Balance Enhancement and Ulcer Prevention (BEUP) research group.
Do Insoles Work?
The group’s work goes back to the 2000s, when the Group Lead, Dr Joanne Paton, conducted a PhD on the role of insoles in reducing ulcer risk. The associated Randomised Controlled Trial was the first to show that prefabricated insoles can be a clinically effective and cheaper alternative to custom-made insoles, thus reducing the waiting time for patients to receive suitable insoles
However the study also found that despite there being no change in their physical appearance, the ability of insoles to reduce pressure reduced over time. Consequently there was a need for insoles to be reviewed annually through in-shoe pressure analysis equipment – consisting of a thin sensor that goes inside the shoe and collects data on the difference the insole makes in terms of pressure.
A picture of the insoles used for Joanne Patton’s PhD
Dr Sam Glasser. In the Movement Laboratory at PAHC. This is motion analysis equipment called CODA it is used to measure movement and balance.
Maintaining Balance and Preventing Falls
Over a period of 5 years, with funding from the National Institute of Health Research, the team (Joanne Paton, Richard Collings, Jon Marsden, and Sam Glasser) explored the impact of different insoles on measures of balance, walking and falls. The team led a systematic review with collaborators from the Universities of Queensland and Auckland and triangulated the findings with those from their own studies. The results challenged the clinical consensus that insoles with an arch support may make some patients with sensory loss more unstable and established that soft cushioned insoles are safe. This was also the first research to suggest that textured insoles may improve the balance and walking consistency of people with sensory perception loss.
Supporting Clinicians through an Algorithm
The above research was brought together in a further systematic review, funded by NIHR and led by Richard Collings (with Jos Latour, Jenny Freeman, and Joanne Paton). The findings were used to underpin a novel algorithm which clinicians can use to identify a particular walking pattern in the patient, and therefore design the most appropriate insole. After a successful feasibility study supported by Siobhan Creanor and the team at PenCTU, the group are now looking to proceed to a full large scale trial.
Richard Collings who led the systematic review
Encouraging Insole Use – The Patients’ Voice
Group research also indicated that many patients were not wearing their insoles enough to make a difference. This triggered a qualitative study (involving Joanne Paton, Ann Roberts and Jon Marsden, funded by NIHR) about the experiences of people wearing insoles and their reasons for non-adherence, which revealed the requirement for continuous insole wear went beyond what was socially and personally acceptable. Clinical recommendations included giving patients house shoes/slippers so that they can wear insoles indoors, something which was successfully implemented in a local Podiatry clinic LIVEWELL Plymouth. This research theme has evolved beyond insole adherence to support patients to self-manage against diabetic foot ulceration and amputation.
Further research is being undertaken by the group including a NIHR funded project led by Jenifer Williams to look at the correlation between patient motivation for diabetic self-care and the state of their feet. The group have drawn on the expertise of Lynne Callaghan (a physiologist with behaviour change expertise) to complete their most recent publication (Joanne Paton, Richard Collings, Jen Williams, Sally Abey and Phil Hendy): a scoping review that revealed the behaviour change recipe for interventions to best support people with diabetes to self-care for their feet. The group are now using this information to develop theory-based interventions to improve diabetic self-management.
Innovation in Practice – The Instant Insole Clinic
Several years ago in collaboration with Mike Oliver a LIVEWELL partner, the team launched a new NHS community based preventative pathway to better serve patients by reducing waiting times, appointment visits and removing the trial and error approach to evaluating insole performance. Using in-shoe pressure analysis technology the pathway enabled the provision of insoles, which surpassed the performance of existing insoles, in a single appointment. The pathway also educated and informed patients of their individual foot ulcer risk thus encouraging increased insole usage. A clinical audit found that a total of 91% and 93% of instant insole clinic patients were alive and ulcer free at 6 and 12 months follow up respectively, while eighteen patients (75%) with a history of ulceration remained healed.
Dr Joanne Paton in the Instant Insole Clinic
Someone walking whilst having data collected using the fscan.
Beyond Plymouth – Research Impact across the NHS
The BEUP group’s findings have also helped influence practices across the NHS more widely. Prior to their work, patients were usually provided with custom made devices despite the delays and cost involved, and the associated increase in risk. Under the influence of the group’s findings, alongside later studies, prefabricated insole use for people with diabetes is now widespread. This has helped reduce the chance of patients developing ulcers whilst they wait for their insoles. Similarly, NHS trusts in other parts of the UK have used the group’s findings to develop a business case for purchasing in-shoe pressure analysis equipment.
Spreading the Word – a Clinical Regional Network
Keen to work with other academics and clinicians, the group organised a Diabetic Foot Clinical Network Offloading Group which held its inaugural meeting in Taunton in July 2019. The network aims to translate the results from published research to influence and inform everyday practice. The event brought together clinical specialists from ten NHS Trusts across the South West alongside representation from the NHS England and the South West Cardiovascular Clinical Network. Whilst the network’s 2020 international conference was postponed to 2021 due to Covid-19, the team hosted a virtual international research conference with the University of Gothenburg, Sweden in December 2020. At a time of increasing pressure on the health service, it is hoped that such collaboration will support those working on the frontline to prevent diabetic foot ulceration.
The 2019 Conference in Taunton
Current BEUP Projects
Mechanisms of behaviour change used to prevent diabetic foot ulceration (Joanne Paton, Research Team Lead. Podiatrist, Researcher and Lecturer Podiatry)
Effects of foot and ankle joint mobilisations combined with home stretches on ankle and big toe ROM and forefoot peak plantar pressures in people with diabetes (Vasileios Lepesis, Physiotherapist and Podiatrist, Lecturer Physiotherapy and Doctoral Student)
INSTEP feasibility study comparing the effectiveness of a novel instant optimised insole with a standard insole for people with diabetic neuropathy (Richard Collings, Clinical Academic Podiatrist and NIHR Doctorial Fellow)
The HOPE Programme: Improving foot care self-management in those at risk of diabetes complications (Jennifer Williams Clinical Academic Podiatrist. NIHR Pre-Doctoral Student)
Cardiovascular determinants of Diabetic Peripheral Neuropathy with and without pain (Calvin Howorth, Podiatrist, Lecturer in Podiatry, PhD student)
The impact and management of odema in people with diabetic foot ulceration (Justine Williams Clinical Academic Vascular team lead)
The prevention and management of foot ulcer secondary to diabetic and leprotic neuropathy and its associated risk factors in a Nepalese Population (Aban Gautam Medic Nepal)
Our long-term aim is to translate the results from our published research to influence and inform everyday clinical practice to focus on the problems faced by people with diabetes and neuropathy. The group involves researchers, podiatrists, physiotherapists and people with diabetes. Together we apply specialist knowledge of diabetic foot ulcer management, foot pressure analysis, orthotic design, balance problems and walking disorders.
The team has secured grants in excess of £1 million pounds in collaboration with industry, other universities, and the NHS. Current studies in the portfolio include an automated 3D-printed insole, a novel balance enhancement insole, research examining balance control in people with diabetes and a clinical trial testing pressure data guided insoles.
Plymouth Institute of Health and Care Research
Our work is grounded in the needs of the people of the South West and other rural, coastal, and deprived communities worldwide, but PIHR’s research has national and international reach and impact.