Objective: To describe and discuss the difficulties in developing an evidence-based guideline for preventing and managing diabetic foot problems when a systematic review of the evidence showed few good quality studies.

Methods: An Expert Panel agreed on the key questions to be addressed in the review. The Expert Panel consisted of specialists in diabetes care - endocrinologists, diabetes educators, podiatrists, consumers, general practitioners, epidemiologists and representatives from the NSW Department of Health.

The three key questions to be addressed in the review were:

1. What clinical features predict the development of foot problems?
2. Does foot care education improve patient knowledge and foot care skills or prevent foot problems developing?
3. Do specialised foot clinics improve healing of active foot problems or reduce amputations compared with non-specialised care?

A systematic and explicit approach was followed to locate, evaluate and summarise the evidence for the guideline.

Discussion:

* Decisions on appropriate clinical management are made in the face of uncertain evidence.
* Even when randomised controlled trials (RCT) have been performed, the quality of a specific study cannot be assumed.
* In describing levels of evidence for a guideline, some indication of the quality of the evidence relating to the guideline is necessary.
* The ethics of recommending an RCT when clinical practices are well established.