Welcome
Support Centre
24 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Honey as Adjuvant Leg ulcer Therapy: A randomised controlled trial of a honey-impregnated dressing for venous leg ulcers
ISRCTN ISRCTN06161544
DOI 10.1186/ISRCTN06161544
ClinicalTrials.gov identifier
EudraCT number
Public title Honey as Adjuvant Leg ulcer Therapy: A randomised controlled trial of a honey-impregnated dressing for venous leg ulcers
Scientific title
Acronym HALT
Serial number at source N/A
Study hypothesis The HALT trial is an open-label, multi-centre, randomised,
controlled clinical trial assessing the effect of manuka honey on ulcer
healing, in patients with venous ulcers. Patients will be randomised to receive either manuka honey dressings or usual care (dressing of clinician's choice) for 12 weeks or until the ulcer has healed, whichever is sooner.
This intervention will be against a background of standard compression
therapy. Allocation is by central telephone randomisation. The sample is
stratified by ulcer size, ulceration duration and study centre. The objective of the study is to determine the effectiveness of manuka honey as an adjuvant to compression therapy in community-based patients with venous leg ulcers. Where the participant has more than one leg ulcer, the largest ulcer is selected as the reference ulcer.
Lay summary
Ethics approval The Auckland Ethics Committee (Committee X). Date of approval: 09/12/2003 (ref: AKX/03/09/232)
Study design Randomised controlled trial
Countries of recruitment New Zealand
Disease/condition/study domain Venous or mixed venous/arterial leg ulcers
Participants - inclusion criteria 400 community-based participants treated by district nurses, each with venous leg ulcer (clinical history, ABI >0.8) or mixed venous/arterial ulcer (clinical history, ABI >0.7), and being treated with compression bandaging.
ABI = Ankle Brachial Index
Participants - exclusion criteria 1. Unable to provide informed consent
2. Have pre-exisiting diagnosis of diabetes
3. Have pre-existing diagnosis of rheumatoid arthritis
4. Have allergy to honey
Anticipated start date 01/05/2004
Anticipated end date 31/08/2005
Status of trial Completed
Patient information material
Target number of participants 400
Interventions Honey-impregnated calcium alginate dressing as an adjuvant to compression bandaging versus usual care (compression bandaging plus dressing of clinician's choice).
Primary outcome measure(s) Number of participants with completely healed reference ulcers at 12 weeks
Secondary outcome measure(s) Time to healing, percentage change in ulcer size, recurrence at six months, health related quality of life, number of dressing changes, costs, and adverse events.
Sources of funding Primary funder: Health Research Council of New Zealand, grant No: 03/087.
Additional support: ApiMed Medical Honey Ltd and USL Medical Ltd
Trial website http://www.ctru.auckland.ac.nz/research/halt/index.html
Publications Results in http://www.ncbi.nlm.nih.gov/pubmed/18161896
Contact name Mr  Andrew  Jull
  Address Clinical Trials Research Unit
University of Auckland
Private Bag 92019
  City/town Auckland
  Zip/Postcode 1003
  Country New Zealand
  Tel +64 9 373-7599 extn 84744
  Fax +64 9 373-1710
  Email a.jull@ctru.auckland.ac.nz
Sponsor Health Research Council of New Zealand
  Address PO Box 5541
Wellesley St
  City/town Auckland
  Zip/Postcode 1001
  Country New Zealand
  Tel +64 9 379 8227
  Fax +64 9 377 9988
  Email bscoggins@hrc.govt.nz
Date applied 08/02/2004
Last edited 13/02/2008
Date ISRCTN assigned 22/03/2004
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.