| Study no |
FUTU
03/03 |
| Short title |
Study
of the feasibility of undertaking an evaluation of the benefit of
education in the primary prevention of foot ulcers in an at risk of
people with diabetes - Footbridge Feasibility Study |
| Sponsor |
Nottingham and Derby R&D |
| Background |
Those with diabetes most at risk of
developing a foot ulcer for the first time are those with loss of
protective sensation (peripheral neuropathy). It is recommended that
this group should be referred for specialist education – although (i)
facilities for this do not routinely exist, and (ii) education has not
been shown to prevent ulcers. |
| Aim of study |
This is a pilot study designed to
identify/refine
- the mechanism for ascertaining those
at risk in the population,
- the structure of the educational
intervention
- outcome measures (including costs
and HRQoL)
- to plan and seek funding for a
definitive RCT
|
| Trial design |
Pilot,
but incorporating assessment of the prevalence of neuropathy in
diabetes, and previous and active ulcers |
|
Details |
The study will
involve analysing anonymised data from held on general practice
databases throughout Gedling PCT in Nottingham (pop 100,000). These data
will be supplemented by formal foot examination in those who consent to
participate |
|
Coapplicants and
other members
of TMC
|
-
Dr Fran Game
-
Mrs Julia Williams
-
Prof Nadina Lincoln
-
Dr Martin von Fragstein
-
Dr Heather Fortnum
-
Dr Sarah Armstrong
-
Dr Kate Radford
-
Ms Tracey Sach
-
Mrs Jane O’Brien
|
| Principal investigator |
Dr William Jeffcoate |
| Trial co-ordinator |
Maureen Smith |
| Time line |
12 month study started September 2003 |
| Current situation |
LREC
approval obtained, R&D approval awaited |
![[Under Construction]](images/undercon.gif)
