INSTEP project

INSTEP project

The team has secured grants in excess of two million pounds in collaboration with industry, other universities, and the NHS. Current studies in the portfolio include a clinical trial testing pressure data guided insoles, designing a behavioural intervention to prevent foot ulceration, testing the feasibility of exercises to reduce forefoot ulceration, exploring the possible links between the ability to self-care and the risk of foot ulcer, designing an intervention for offloading diabetic foot problems with lymphoedema.

Current research projects

Diabetic foot ulcers complicated by the effects of lower limb oedema and its complications – a developing project – Justine Tansley

Project Lead: Justine Tansley

Lower limb wound healing can be prolonged in those with diabetes and is further exacerbated if lower limb oedema is present. These common co-morbidities further increase the risk of individuals experiencing recurrent infection, wound deterioration, pain, immobility and amputation, all of which have a profound impact on quality of life.

This developing project aims to improve the care and experiences of people with diabetic foot ulceration when it occurs in combination with lower limb oedema and other lower limb complications. It will explore the best approaches to manage these conditions including complex interventions and integrated care.

To date the project has been able to identify that barriers to treatment exist at a national scale, where diabetic foot ulcers present in combination with lower limb oedema and its concurrent complications. It has further discovered this is an area of clinical practice and professional development which desperately seeks improvement by those involved in delivering care and people living with these conditions. A scoping review is currently being undertaken to explore “Off-loading and compression therapy interventions and strategies for the treatment of diabetic foot ulcers complicated by the effects of lower limb oedema”.

Patient Activation and Foot Health in Diabetes – Jennifer Williams

Project Lead: Jennifer Williams
A cross-sectional, epidemiological study to investigate the association between patient activation level and foot disease in adults with Diabetes Mellitus.
For those with diabetes the level of engagement and involvement in their disease management plans and self-care practices, referred to as patient activation, can predict their health outcomes, with higher activation levels resulting in better health outcomes. International guidelines recommend that individuals with diabetes and foot risk factors complete daily self-care and monitoring of their feet, in addition to avoiding risky behaviour which can reduce foot ulceration, hospitalization, and amputation risk. 
A focus group with patients living with diabetes suggested that the motivation for sustained engagement with foot self-care practices was difficult to maintain on a long-term basis.  Fatigue with the constant need of managing their diabetes condition was common. These factors are thought to be directly linked to the level of patient activation. Despite this, a low patient activation level is not considered as a risk factor for developing foot complications in people with diabetes. Currently, there is a lack of evidence to directly link low patient activation levels with an increased risk of foot complications for people with diabetes.
The study aims to investigate if an individual’s level of activation in managing their own health care is associated with the level of diabetic foot ulcer risk. 
Participants are individuals with diabetes at risk of foot ulceration and registered with the podiatry department of an NHS Trust. The study involves the collection of epidemiological and demographic data and the participants completion of the patient activation measure questionnaire.

INSTEP: Insoles to Ease Plantar Pressure – Richard Collings

Project Lead: Richard Collings

Foot ulceration is one of the most devastating problems associated with diabetic peripheral neuropathy. One type of foot ulcer that is found in approximately 50% of cases is those on the underside of the foot and is associated with high plantar pressure areas.

A feasibility RCT with embedded qualitative component tested an optimised insole intervention appropriate for chairside delivery plantar that aims to reduce foot pressure in people with diabetes. Insoles and specialist shoes are often provided to transfer areas of high pressures to other parts of the foot in an attempt to reduce the risk of ulcers. The ‘optimised’ insole design was informed by data collected from high tech in-shoe pressure measurement equipment.

Sixty-one participants were randomised to either the optimised insole group (n=30) or a plain insole group (n=31). Forty-two participants completed the study at 12-months and we found that the differences in pressure reduction favoured the optimised insole group.

The results of the feasibility study suggest that the optimised insole holds promise as an intervention. Therefore, this information will be used to develop a funding application to undertake a large-scale multi-centre trial to evaluate its clinical and cost-effectiveness for people with diabetic peripheral neuropathy.

Foot Risk Awareness and Management Education (FRAME) – Dr Joanne Paton

Project Lead: Dr Joanne Paton

The Foot Risk Awareness and Management Education (FRAME) project was commissioned by the Scottish Government to produce an e-learning resource to enable any Health Care Professional (HPC)/workers to gain knowledge of the theoretical and practical competencies to safely and effectively undertake the task of diabetes foot screening. Building upon this work a second project was commissioned by the SW Clinical Network in England in response to a peer review of diabetic foot services across the South West region that highlighted a need for education in the assessment of the diabetic foot.

The aim of the project was to modify and update the module content to reflect English NICE guidance. The module is intended to provide those working in primary care with an interactive way of learning with the aim of standardising, in an evidence based manner, the way diabetes foot screening is performed throughout England.

On completion of this module the individual may opt to undertake case scenarios, and if completed successfully and passed, will gain a certificate of completion/competence.

The original project was officially launched at The Scottish Diabetes Foot conference in Dynamic Earth, Edinburgh on 6th June 2011.

The English version of FRAME was launched on 1st February 2017 and is updated annually.

The English version of FRAME project was commissioned by the Rachel Leverson (SW Clinical Network). English module content modified by Joanne Paton and reviewed by

  • Dr Richard Paisey: Honorary consultant and SW CVD SCN Diabetes Footcare Lead
  • Dr Julia Thomas: Consultant Physician and Endocrinologist at Musgrove Park Hospital
  • Anita Stuart: Diabetes Specialist Podiatrist at Derriford Hospital Plymouth.
  • Alysia Kirby: Specialist Podiatrist- Diabetes at West Cornwall Hospital
  • Christiane Pankhurst; Senior Orthotist at Guys and St Thomas’ Hospital

INPUT: The development of a patient centred approach to Improve iNsole self-management for foot Protection in people at risk of first diabetic foot UlceraTion – Dr Joanne Paton

Project Lead: Dr Joanne Paton

Research has shown that despite clear benefits of using insoles to prevent foot ulceration in people living with diabetes. People lack motivation to use insoles because they cannot feel injury done to their feet, do not understand the benefits of insoles or know when to wear them.

Previous research studies have focused on improving patients’ knowledge and understanding of their foot care through provision of traditional educational materials, such as leaflets. These have proved only partially successful in increasing adherence to (wearing of) insoles. We believe that the amount, and length of time wearing the insoles can be increased by improving someone’s understanding of why insoles are needed in the self-management of their feet. Using a systematic process, we developed a new treatment regime to support people living with diabetes to wear their insoles more. It has four components to motivate and encourage people to take ownership of how to best to use their insoles day-to-day to prevent foot ulcers:

  • Assessment of foot ulcer risk and insole benefit
  • Personalised health coaching to increase motivation
  • Fitting insoles into the shoes or slippers worn most often
  • Follow up to reinforce learning and instruct people how to check insoles for wear and tear and get replacements
Next we plan to test the feasibility of this new approach in a clinical trial.

SBRI Healthcare Project: Low-cost personalised insoles for diabetic insoles for foot ulcer prevention – Dr Joanne Paton

Project Lead: Dr Joanne Paton

This project successfully developed a feasible system to automatically create a bespoke insole for people at risk from diabetic foot ulceration, a serious problem affecting 61,000 people at any one time.

It achieved this through a combination of 3D scanner (CADSCAN Ltd), 3D printer (Gyrobot and Recreus) and algorithms (Staffordshire University) to automatically design the insoles to meet stakeholder specifications (Plymouth University). The resulting insoles are cheap to manufacture and can be printed at the point of care within hours. Pre-clinical evaluation undertaken by the research team at Plymouth found that the new 3D printed insole was more effective at reducing plantar loads under the forefoot when compared to the standard insole condition, reducing mean peak pressure by 31% compared to a 27% reduction when a standard custom insole was worn. Early evaluation of the next generation of 3D printed insoles suggested that there is potential to further optimise the design and performance of the 3D printed insole, with initial tests demonstrating a reduction of forefoot peak pressure of 38%.

Foot and Ankle Mobilisation in Diabetic Peripheral Neuropathy (DPN) – Vasileios Lepesis

Project Lead: Vasileios Lepesis

Limited joint mobility syndrome (LJMS) is the most common musculoskeletal complication in diabetes which is caused by glycosylation of connective tissue collagen. Reduced ankle and metatarsophalangeal (MTP) range of motion (ROM) seen in LJMS leads to increased elevated forefoot plantar pressure while walking, a known risk factor for ulceration.

A proof-of-concept assessor blinded randomised controlled trial with an embedded qualitative element assessing whether ankle and first MTP joint mobilisations and home program of stretches in people with DPN improve joint ROM and reduce forefoot peak plantar pressures.

Sixty-one participants were randomised to either mobilisations and stretches group (n=31) or diabetic usual care (n=30). Outcome measures were taken at baseline; post intervention and 3- months following intervention onset. Dynamic ankle ROM and plantar pressure measurements did not differ between groups but static ROM measurements in the ankle and big toe significantly increased in the intervention group. Participants interviewed found the intervention acceptable and showed high adhesion rates (80%).

Changes in the primary outcome, dorsiflexion range while walking was not observed. This may reflect an inclusion based on limited joint mobility identified through clinical tests and the method of defining ankle range with 3D motion analysis. This suggests that further work in more targeted patient populations is warranted.

Developing a person-centred decision-aid for supporting footwear choices for those at risk of diabetes-related foot ulceration – Sally Abey, Krithika Anil

Project lead: Dr Sally Abey, Dr Krithika Anil 
Diabetes-related foot ulceration is a serious common condition that is life-threatening and considerably reduces quality of life. Well-fitting footwear can prevent foot ulceration but many people living with diabetes do not wear the correct footwear. Research suggests that this is because footwear provided by clinicians ignore individuals’ needs and their lifestyle.
From our discussions with people living with diabetes, they felt that although their clinician was the person to give them relevant footwear, they needed clearer information in language that they could understand, where the risks and benefits were clear, and considered their individual lifestyle.
Similarly, our engagement with practitioners (podiatrists, orthotists, endocrinologists) revealed uncertainty over what footwear styles, designs or features could be both clinically acceptable and meet individual lifestyle needs. This resulted in clinicians not being able to connect, communicate, and support their patients to wear the right footwear to prevent foot ulceration. 
There is currently a demand to align the perspective of the practitioner with people living with diabetes. We are developing a decision-aid that can address this demand and achieve better footcare outcomes by considering individual needs and providing easy-to-read footwear information that supports footwear choice to prevent foot ulceration.

Clinical Impact of the BEUP Research Group

This project will enable the development of a sustainable network of clinical influence and impact monitoring, to accelerate the clinical implementation of BEUPs current and future work. This project provides a timely opportunity for the BEUP Research Team, to partner regional NHS colleagues, to develop and implement evidence based solutions and clinical recommendations to standardise regional practice. Once developed the recommendations will be disseminated for nationwide adoption. The proposed activities are organised around two themes; NHS and public engagement to inform clinical guidelines; implementation and evaluation of guidelines into practice.  These activities are designed to address the immediate clinical need for a standardised diabetic insole pathway. Over the duration of the project, each work stream systematically builds evidence of impact, whilst extending the geographical reach of the groups influence.
Dual purpose insole
The BEUP insole
Work stream 1: Service evaluation to provide evidence of local research impact
Over the last four years the BEUP team have run a research informed NHS insole clinic resourced by Livewell Southwest Podiatry. During that time service delivery and patient outcome data has been collected and analysed. 
Patient-related outcomes:
  • A total of 91% and 93% of patients attending the instant insole clinic were alive and ulcer free at 6 and 12 months follow-up, respectively.
  • Eighteen patients (75%) with a history of ulceration remained healed at the time of audit. Seven of these had active ulcers at first assessment within the clinic. Five of the seven (75%) have healed since attending the clinic without amputation. This compared well to the 65.7% healing rate reported in the literature.
  • A total of 95% of the 61 patients attending the instant insole clinic without prior foot ulceration remained ulcer free, leaving 5% who subsequently developed a first foot ulcer. 
  • To be effective in reducing ulceration risk, insoles are recommended to be worn all day, every day.  At total of 90% of patients who were issued insoles got into the habit of wearing their insoles every day, although only 60% of patients reported following the  recommendation to wearing their insoles continuously all day.
  • All patients attending the clinic were very satisfied or satisfied with the level of service they received. 
  • Patients attending the clinic, on average, were assessed, treated, reviewed and discharged over the course of two appointments.
Work stream 2: Establish a sustainable regional clinical group specialising in insoles for preventing diabetic foot problems (SW Region)
The inaugural meeting of the diabetic foot clinical network offloading group was held in Taunton. The event comprised of clinical specialists from a wide variety of disciplines inclusive of orthotic, musculoskeletal, diabetes and management from ten NHS Trusts across the South West (SW) region. The event was further supported with representation from the NHS England and the SW Cardiovascular Clinical Network.
Post-conference evaluation recognised the importance of offloading in the reduction of diabetic foot ulceration and the need for consistency across the region in regards to outcomes and practices. 
In response to this feedback we ran the second Biomechanics and the diabetic foot conference: Sharing good practice.
The BEUP team were delighted to be joined at this event by Ulla Hellstrand Tang and her team of Orthotists and Prosthetists and Gustav Jarl all from Sweden. The group joined together with a common purpose to share best practice to improve patient care. Over 60 delegates from across the UK and Sweden joined the online event. 
Topics covered fundimentals of biomechanical diabetic foot screening and triage, better load management to prevent re-uleration, Pressure analysis and its use in practice, adherence to clinical guidelines, the importance of plantar pad positioning, consideration of gait and quality of life changes in people with diabetes over time, lessons to be learned from amputation incidence and regional variations in Sweden.