Honey as Adjuvant Leg ulcer Therapy: A randomised controlled trial of a honey-impregnated dressing for venous leg ulcers
| ISRCTN | ISRCTN06161544 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN06161544 |
| Secondary identifying numbers | N/A |
- Submission date
- 08/02/2004
- Registration date
- 22/03/2004
- Last edited
- 13/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Andrew Jull
Scientific
Scientific
Clinical Trials Research Unit
University of Auckland
Private Bag 92019
Auckland
1003
New Zealand
| Phone | +64 9 373-7599 extn 84744 |
|---|---|
| a.jull@ctru.auckland.ac.nz |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Multi-centre |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | HALT |
| Study objectives | 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(s) | The Auckland Ethics Committee (Committee X). Date of approval: 09/12/2003 (ref: AKX/03/09/232) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Manuka honey |
| Primary outcome measure | 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 study start date | 01/05/2004 |
| Completion date | 31/08/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 400 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2004 |
| Date of final enrolment | 31/08/2005 |
Locations
Countries of recruitment
- New Zealand
Study participating centre
Clinical Trials Research Unit
Auckland
1003
New Zealand
1003
New Zealand
Sponsor information
Health Research Council of New Zealand
Research council
Research council
PO Box 5541
Wellesley St
Auckland
1001
New Zealand
| Phone | +64 9 379 8227 |
|---|---|
| bscoggins@hrc.govt.nz | |
"ROR" |
https://ror.org/00zbf3d93 |
Funders
Funder type
Research council
Primary funder: Health Research Council of New Zealand, grant No: 03/087.
No information available
Additional support: ApiMed Medical Honey Ltd and USL Medical Ltd
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/02/2008 | Yes | No |
