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Footbridge feasibility study

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

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