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.
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.
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.