Improving outcomes in patient with diabetic foot disease

Project Description

Diabetes is the fastest growing health crisis of our time. One person with diabetes dies every 6 seconds. In the UK a new person is diagnosed every 2 minutes and care of diabetes currently costs the NHS £1million per hour, every hour. Diabetes is not only a killer disease, but causes complications which result in severe limitations in function and quality of life. Most of the deaths and severe complications of diabetes are related to vascular disease. Vascular disease with or without diabetes is the most common cause of death in adults and one of the most common causes of major disability.

One area of the body which is severely affected by diabetes is the foot. A complex syndrome of issues including vascular insufficiency, neuropathy, inflammation and impaired immunity predispose to a vicious cycle of structural changes, abnormal pressure, acute injury, chronicity of healing, infection and tissue loss. This process results in a 1500% increase in leg amputation when compared with the non-diabetic population. Disease of the large and small blood vessels drives these pathological processes and its presence has a significant impact upon the probability of limb salvage. Such vascular disease affects 1 in 3 patients with diabetes over the age of 50. Leg amputation in diabetes is associated with a 5 year mortality of 68 to 77%, which is dramatically worse than for most cancers. Around 40% of those living independently prior to limb loss were not able to do so following recovery. Amputation is therefore associated with mortality, severe functional impairment, severe quality of life impairment for the patient and their carers and considerable health and social care costs. Amputations may be required even in relatively young patients, impacting upon their employment, finances and their dependents as well as the national economy.

NCEPOD and Diabetes UK have highlighted vascular disease in patients with diabetes as a national research priority. A detailed national research priority setting exercise has been performed within the host unit in collaboration with the NIHR, the Royal College of Surgeons, the Circulation Foundation and the James Lind Alliance. This programme is designed to address the top research priorities identified regarding patients with peripheral vascular disease.

There will be three broad workstreams of study:

Targeting revascularisation
Many patients with diabetes have vascular disease placing them at increased risk of losing their leg. Treatment of their arteries to improve blood flow will prevent limb loss in some, but the treatments may also be harmful. There is considerable clinical uncertainty as to the selection of those who need treatment and those who do not. Current methods look at the supply of blood. The intention of this research is to use novel imaging techniques to study the supply and demand of the tissues together. The hope is that this will provide better information and better rates of limb salvage with minimal side effects of treatment.

Prehabilitation and rehabilitation
Patients undergoing major vascular procedures or amputation need to be as fit as they can be in order to minimise the complications and risk of death. Similarly they need to have targeted personalised support following their procedures to ensure the best possible recovery. The aim of this workstream is to identify the optimal package of care and study the impact of implementation.

Augmentation of healing and prevention of infection
Patients with diabetes and vascular disease frequently require surgery to lower limbs and commonly suffer foot ulceration with diabetes hindering the subsequent healing process and increasing the risk of associated limb threatening infections. We recently performed a large NIHR wound healing study which demonstrated that only 57.6% of these wounds healed at 12 months and those that did took a median of 182 days. Emerging technologies including extracorporeal shockwave therapy, negative pressure wound therapy cold plasma and topical oxygen delivery devices have all shown potential for use in diabetic wounds to aid in healing and lessen the risk of significant infection. This project would investigate early clinical outcomes as well as mechanisms of action by which these adjuncts augment healing to pilot their most appropriate use in use in lower limb and foot wounds in diabetes.