Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Mr Andrew Jull
ORCID ID
Contact details
Clinical Trials Research Unit
University of Auckland
Private Bag 92019
Auckland
1003
New Zealand
+64 9 373-7599 extn 84744
a.jull@ctru.auckland.ac.nz
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
HALT
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.
Ethics approval
The Auckland Ethics Committee (Committee X). Date of approval: 09/12/2003 (ref: AKX/03/09/232)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Multi-centre
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Venous or mixed venous/arterial leg ulcers
Intervention
Honey-impregnated calcium alginate dressing as an adjuvant to compression bandaging versus usual care (compression bandaging plus dressing of clinician's choice).
Intervention type
Drug
Phase
Not Specified
Drug names
Manuka honey
Primary outcome measures
Number of participants with completely healed reference ulcers at 12 weeks
Secondary outcome measures
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.
Overall trial start date
01/05/2004
Overall trial end date
31/08/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
400
Participant 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
Recruitment start date
01/05/2004
Recruitment end date
31/08/2005
Locations
Countries of recruitment
New Zealand
Trial participating centre
Clinical Trials Research Unit
Auckland
1003
New Zealand
Sponsor information
Organisation
Health Research Council of New Zealand
Sponsor details
PO Box 5541
Wellesley St
Auckland
1001
New Zealand
+64 9 379 8227
bscoggins@hrc.govt.nz
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Primary funder: Health Research Council of New Zealand, grant No: 03/087.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Additional support: ApiMed Medical Honey Ltd and USL Medical Ltd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/18161896
Publication citations
-
Results
Jull A, Walker N, Parag V, Molan P, Rodgers A, , Randomized clinical trial of honey-impregnated dressings for venous leg ulcers., Br J Surg, 2008, 95, 2, 175-182, doi: 10.1002/bjs.6059.