Balance Enhancement and Ulcer Prevention in Diabetes projects

Balance control and the effect of ankle foot orthoses in people with diabetic peripheral neuropathy

Ankle foot orthoses (AFOs) designed to limit medio-lateral (side to side) motion have the potential to enhance balance in those with diabetic peripheral neuropathy.

People with Diabetic peripheral neuropathy (DPN) suffer from a loss of sensation in the feet. One functional effect of DPN is a decrease in the ability to maintain functional stability, giving rise to an increase in the risk of sustaining a fall.

AFOs have been used successfully to improve balance and stability in other pathologies, however little is known on their effects in those with DPN. This laboratory based study therefore investigated the effect of AFO’s on balance and stability and explored the mechanism by which they work .

AFOs were found to reduce body sway and improve balance when recovering from a induced state of imbalance, a potential benefit for the DPN population

It is intended that the findings from this research will be used to inform the development of an AFO suitable for clinical use. New knowledge about how people recover when unbalanced will be used to develop a multi-sensory balance re-training program targeted at those with diabetic peripheral neuropathy.

The BEUP insole: the development and clinical evaluation of a new dual purpose insole used for balance enhancement and ulcer prevention (BEUP) in neuropathic individuals with diabetes

Two new prototype insoles for people with diabetes were designed, tested, and found not to compromise balance when worn.

Foot ulceration is a devastating complication of diabetes often ending in amputation. Insoles are used to protect diabetic feet from ulceration. Some patients choose not to wear protective insoles because they make them feel unsteady and more likely to fall. It is therefore important to design insoles that are protective but also feel safe for people to wear.

Two new prototype insole designs were informed by our own research data gathered from talking to people with diabetes who wear insoles, a review of the existing evidence on the topic, and an exploratory study that compared new and standard insoles to see which was best at improving the balance of people with diabetes.

The prototype insoles have been tested in a small feasibility clinical trial designed so that each volunteer trialled both insoles. High tech equipment was used to measure the impact of each insole on balance; whilst the volunteers were asked to choose which insole they thought was best. 

Unlike the standard diabetic insole, neither of the two new insole designs compromised standing balance and therefore can be considered safe for people with diabetes to wear. One of the insole designs was preferred by our volunteers, because it was easier to take on and off and was less visually intrusive.

Foot Risk Awareness and Management Education (FRAME)

The 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 6 June 2011.
The English version of FRAME is officially launched on 1 February 2017.

The English version of FRAME project has been comissioned 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

INsTEP – INSoles To Ease Pressure: a mixed methods feasibility study

To investigate the effectiveness of a new instant insole solution to reduce the risk of diabetic foot ulcer occurrence.

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. 

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.

Richard is undertaking a mixed-methods pilot study to develop and test a training package to produce a bespoke insole design. The personalised insole design will be informed by data collected from high tech in-shoe pressure measurement equipment. One benefit of the training package is that the bespoke insole produced can actually be fitted and issued to the patient on the same day.

The pilot study will inform a large scale multi-centre trial to evaluate clinical and cost effectiveness of this novel idea. Ultimately the findings will be used to change the way that the Podiatry services around the country work to produce insoles to reduce the risk of people with diabetes developing foot ulcers.

INPRINT: Low-cost personalised insoles for diabetic insoles for foot ulcer prevention 

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 (University of Plymouth). 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%. 

Building on the developments of Phase 1, Phase 2 is now underway to create a complete system that can be deployed by the NHS.