Condition category
Circulatory System
Date applied
08/02/2004
Date assigned
22/03/2004
Last edited
13/02/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ctru.auckland.ac.nz/research/halt/index.html

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

  1. 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.

Additional files

Editorial Notes