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HTA dressings study

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
  • Funded from July 2003

  • Clinical recruitment from November 2003

  • Finish data November 2006
Current situation

Final collaborators’ meeting to be held 30th/31st October 2003

 


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