Core Outcome Measures in Effectiveness Trials

Development of a core outcome set for diabetic foot ulceration

General Information

Summary:
Foot ulceration will affect 15% of diabetic patients throughout their lifetime. They are associated with significant morbidity including major limb amputation, as well as mortality. It is an area of exiting research and novel therapeutic innovation. No current outcome set exists for the management of DFU's. This study aims to develop a core outcome set for interventions for diabetic foot ulceration.

Contributors:
Mr George Dovell - ACF ST3 Vascular Surgery
Professor Robert Hinchliffe - Professor of Vascular Surgery
Bristol Centre for Surgical Research
School of Social and Community Medicine
University of Bristol

Diabetes UK

Further Study Information

Current Stage:
Ongoing
Date:
April 2018 - April 2020
Funding source(s):
None

Health Area

Disease Category
Endocrine & metabolic
Wounds

Disease Name
Diabetes mellitus
Diabetic foot ulcer/ulceration

Target Population

Age Range
16 - 100

Sex
Either


Nature / type of Intervention
Any

Method(s)

Consensus conference
Consensus meeting
Delphi process
Interview
Literature review
Semi structured discussion
Systematic review

Long list of outcomes will be identified from 3 sources. Firstly a systematic review of the literature. Secondly patient interviews and thirdly from an international steering committee (made up of healthcare professionals and patient representatives).

A 3 round Delphi survey will then be undertaken to condense the long list of outcomes and the final core outcome set will be decided by a consensus meeting of the steering committee.


Stakeholders Involved

Charities
Clinical experts
Consumers (patients)
Epidemiologists
Methodologists
Patient/ support group representatives
Researchers
Statisticians

Study Type

COS for clinical trials or clinical research

The site uses cookies, some may have been set already. Please refer to our privacy policy & cookie usage statement.
If you continue to use the site we'll assume you're happy to accept the cookies.