The Scottish Leg Ulcer Project

Abstract

National and international guidelines on many topics have been introduced in recent years. It is unlikely that the implementation of few, or any, has been evaluated by randomized trial, nor have the impacts of guidelines when combined with training been evaluated. A national guideline produced by the Scottish Intercollegiate Guideline Network (SIGN) entitled `Management of Chronic Leg Ulcer' was published in July 1998 and this may have influence on care and ultimately healing rates of leg ulcers. The purpose of this paper is to describe the design of a Scottish multi-centre trial and to present baseline data.

The Scottish Leg Ulcer Project is a randomized controlled trial which commenced in July 1997 and is designed to compare the impact of the SIGN guideline with the impact of the SIGN guideline reinforced by a formal training programme, on healing rates of leg ulcers. Participants include 16 Scottish community healthcare trusts or health boards, with a population of approximately 2.7 million. Localities have been randomized into control (SIGN guidelines alone) and intervention (SIGN guideline plus a formal training programme). In the intervention localities, link nurses, after intensive training, cascaded similar training to all community staff involved in leg ulcer care. Data are provided by district nurse caseload managers in censuses every three months throughout a six-month baseline and 24-month trial period. The principal endpoint is an ulcer-free leg. The data collection is due to be completed in December 1999, and the project analysed and reported by June 2000.