People with diabetes have a risk of developing chronic ulceration of the foot, especially in later life. These ulcers can take months to resolve and are responsible for enormous cost and suffering. A significant number lead eventually to loss of the lower limb through amputation. But despite the severity of the problem, it is one which has received little attention from health care professionals and health care planners: it is unfashionable. It has attracted little investment and, until recent years, was the focus of little research. The result is that the condition is often managed by generalists with limited detailed knowledge, and not always with access to the necessary resources.

Moves to offset this have resulted in the formation of expert multidisciplinary teams and one of the very first was that at the City Hospital, Nottingham, which was first formed in 1982. It attracts patients from a wide area, and has achieved an international reputation for its work. The clinical staff manage over 400 new problems each year, and their overall rate of amputation is very much lower than in many other places in the world.  However, this clinical activity is underpinned by a programme of research – designed to identify the very best ways of improving clinical care. It was for this purpose that the Foot Ulcer Trials Unit was formed in 2002.

Philosophy

The philosophy of the research undertaken by the unit is to answer questions concerning effectiveness of techniques used in clinical management. The results of the projects undertaken have, therefore, direct clinical relevance. The aim is simply to improve patient care and to reduce suffering.

All research in the Unit is undertaken in strict compliance with the MRC Guidelines for Good Clinical Practice in Clinical Research, and current standards for research governance, including the European Directive on Governance of Clinical Trials. Adherence to these guidelines presents a considerable administrative burden on any research unit and it is partly for this reason that it is becoming increasingly difficult for clinical staff to undertake research into areas such as chronic ulcers of the diabetic foot. Recognising this, our longer term aim is to establish a resource to enable others in UK, and elsewhere in Europe, to undertake the research which is so desperately needed.

In undertaking its clinical research programme, the unit has collaborated with many other specialist teams in UK and in other countries. UK-based studies include a multicentre trial of dressing products, a three-centre study ont he effectiveness of education in preventing ulcer recurrence, a web-based assessment of the outcome of management of Charcot disease and an ongoing study of the effectiveness of a new formulation designed to accelerate wound healing. Multinational studies include a new web-based audit of the outcome of the management of osteomyelitis and a trial of the effectiveness in undertaking bone biopsy for the same condition.

Unit Profile

Early work of the unit centred on basic issues of record keeping and classification, defining details of trial design, and the most appropriate structure for studies in the field. One important question is that of defining end-points: if a new treatment is being evaluated, it is very important to choose the right measures of effectiveness. In addition to ulcer healing, these measures include careful documentation of patient-related end-points, such as mobility, mood and well-being.

From 2002, the Unit has succeeded in attracting funding from non-commercial sources which totals well over a  million pounds, and this underpins the current research programme.