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Research 5

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Close glycaemic control study

Study no FUTU 03/05
Short title

Close glycaemic control study

Sponsor None, apart from reagent support and an unconditional small grant from insulin manufacturers 

It is generally recommended that good sugar control is an important part of foot ulcer management, and yet it may receive less attention than it should it routine practice: mean HbA1c levels exceed 9% in most UK clinics.

Aim of study

To use insulin to determine

  • the feasibility of achieving close blood sugar control within thee months

  • the effect, if any, on wound healing

Trial design Pilot observer-blind RCT
Primary endpoint Glycaemic control and ulcer healing
Details Up to 50 patients with HbA1c >7.5% and who consent will be randomized to either continue current care, or received intensive input to improve glycaemic control using insulin according to a stepped programme.
Participating centres Single centre
Principal investigators Drs William Jeffcoate and Fran Game
Trial co-ordinator Dr Is Idris
Time line

Recruitment over 6 months from 1st January 2004

Finish September 2004

Current situation
  • Awaiting LREC and R&D approval

  • Specialist nurse to be appointed

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