| 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 |
| Background |
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 |
|