| Study no |
FUTU 03/01 |
| Short title |
HTA dressings study |
| Sponsor |
UK Department of Health, Health
Technology Assessment |
| Background |
There are few data available comparing the effectiveness of dressings
commonly used in clinical practice. Choice is governed by experience,
belief and preference, rather than scientific evidence of efficacy. |
| Aim of study |
To compare the
effectiveness and comparative costs of three dressings commonly used in
UK clinical practice: a simple non-adherent dressing (N/A), an
antiseptic dressing (Inadine®) and a modern hydrofibre (Aquacel®). |
| Trial design |
Randomised,
observer-blind, controlled trial |
| Primary endpoint |
Healing (epithelialisation
maintained > 4 weeks) within 6 months |
| Details |
300 patients
attending specialist multidisciplinary clinics for the management of
diabetic foot ulcers will be randomized to have their ulcers dressed
with one of the three products. They will be checked at least each two
weeks by a research nurse/podiatrist, and each three months by an
observer blind to randomisation group. |
| Participating centres |
-
Nottingham City Hospital
- Hull
Royal Infirmary
-
Blackburn Royal Infirmary
-
Ipswich Hospital
- Royal
Gwent Hospital, Newport, Wales
- King’s
College Hospital, London
|
| Lead unit |
Foot Ulcer Trials Unit,
Nottingham City Hospital |
| Principal investigator |
Dr William Jeffcoate |
| Trial co-ordinator |
Viv Savage |
| Time line |
|
| Current situation |
Final collaborators’ meeting to
be held 30th/31st October 2003 |