Predictive factors for foot ulceration in diabetes:a follow-up
Research type
Research Study
Full title
Predictive factors for foot ulceration in diabetes: a follow-up.
IRAS ID
97542
Contact name
Fay Crawford
Contact email
Sponsor organisation
NHS Fife
Clinicaltrials.gov Identifier
NHS REC approval reference (original), 04/S1401/197; NHS R&D ref ID (original), 2004DM04
Duration of Study in the UK
1 years, 11 months, 28 days
Research summary
Our overarching research objectives are to produce an evidence clinical pathway by;
I.Creating and validating a clinical prediction rule to assess the risk of a foot ulcer for people with diabetes
II.Estimating the optimal monitoring time for risk assessments by following up patients outcomes for those who previously consented to participate in an NHS Tayside cohort study. It is this part of our research that is the focus of this ethics application
III. Performing an overview of systematic reviews to identify effective preventative interventions
IV.Combining the evidence from i, ii and iii in a cost effectiveness decision model framework and analyse alternative clinical and cost effective regimens at different monitoring frequencies
V. Conduct a value of information analysis.
We will use Individual Patient Data (IPD) collected from patients with diabetes from studies conducted worldwide (acronym PODUS) to develop a clinical prediction rule by producing a simple scoring system for use in clinical practice using these data.
Monitoring intervals will also be calculated by our team using a sub set of the PODUS data and in consultation with clinical colleagues. We wish to collect long term follow-up data from patients who previously consented to their medical and health records being monitored in a cohort study conducted in NHS Tayside. It is this element of the research which requires the attention of the ethics committee.
We will also conduct a review of preventative interventions, then the CPR and the data-driven monitoring intervals will comprise the evidence-based clinical pathway.
We then propose to construct a decision analytic economic model incorporating our evidence based pathway and conduct cost effectiveness analyses comparing it with the current recommended pathways in the NICE and SIGN diabetes clinical guidelines.REC name
Scotland A: Adults with Incapacity only
REC reference
16/SS/0213
Date of REC Opinion
20 Dec 2016
REC opinion
Favourable Opinion