Use of honey for the treatment of leprosy ulcer
| ISRCTN | ISRCTN10093277 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10093277 |
- Submission date
- 16/11/2021
- Registration date
- 22/12/2021
- Last edited
- 31/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
As in diabetes, ulcers in leprosy result from nerve damage and the resulting loss of sensation. Neuropathy in leprosy is caused primarily by inflammatory ‘reactions’, which occur in 30-50% of leprosy cases. Neuritis (nerve inflammation) can develop at any time before, during or even years after leprosy treatment. The combination of loss of sensation and deformities leads to recurrent ulcers and these often present when they are advanced. People afflicted with recurrent ulcers suffer severe consequences in terms of loss of function, loss of earnings and stigma, frequently becoming chronically depressed and withdrawn. This study evaluates a promising intervention to promote healing for leprosy ulcers. The use of honey to treat wounds is an ancient practice. Although there is a sizeable number of reports that show mixed levels of effectiveness in the use of honey for the treatment of different types of wounds, there is a lack of reports on the use of honey in the treatment of ulcers in leprosy. This study will evaluate the healing properties of raw, undiluted African honey in comparison with normal saline (saltwater) dressing of leprosy ulcers.
Who can participate?
Patients aged 18 years and above with chronic foot ulcers due to leprosy neuropathy (ulcer surface area 2-20 cm²)
What does the study involve?
Participants will be randomly assigned to treatment with either honey or normal saline on their foot ulcers twice a week until the wound is completely healed. The participants will be asked to wear pedometers on the foot to determine whether their level of physical activity influences the healing process or not.
What are the possible benefits and risks of participating?
The possible benefit to the participants is that their ulcers will be treated at no cost. The possible risks to participating in this study are minimal because the intervention (honey) is a well-known traditional agent for the treatment of wounds. The Leprosy Mission Nigeria will provide a non-negligence insurance cover to the study participants.
Where is the study run from?
The study will be run from The Leprosy Referral Hospital Chanchaga, Minna, Niger state, and will be run by The Leprosy Mission Nigeria.
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Paul Tsaku
tsakup@tlmnigeria.org
Contact information
Scientific
The Leprosy Mission Nigeria
14/16 Kings Drive
Fort Royal Homes Estate
Lugbe
Abuja
000
Nigeria
 ORCID ID |
0000-0001-9490-4112 |
|---|---|
| Phone | +234 (0)7035425305 |
| tsakup@tlmnigeria.org |
Public
The Leprosy Mission Nigeria
14/16 Kings Drive
Fort Royal Homes Estate
Lugbe
Abuja
000
Nigeria
| Phone | +234 (0)7035425305 |
|---|---|
| tsakup@tlmnigeria.org |
Study information
| Study design | Multi-centre comparative prospective single-blind parallel-group 1:1 individually randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Honey Experiment on LeProsy Ulcer (HELP): a randomised control trial of raw, unadulterated African honey for ulcer healing in leprosy |
| Study acronym | HELP |
| Study objectives | To evaluate the healing properties of raw, undiluted African honey in comparison with normal saline dressing of leprosy ulcers. |
| Ethics approval(s) |
1. Approved 06/10/2021, Niger State Government Ministry of Health Research Ethics Committee (Block 'C' First Floor, Abdul-Kareem Lafene Secretariat Complex, Paiko Road, PMB 57, Minna, -, Nigeria; +234 (0)8038246018; ngsmohmx@yahoo.com), ref: STA/495/Vol/199 2. Approved 19/01/2022, National Health Research Ethics Committee (Abuja, Abuja, -, Nigeria; +23495238367; info@nhrec.net), ref: FHREC/2022/01/09/04-02-22 |
| Health condition(s) or problem(s) studied | Leprosy ulcer |
| Intervention | Participants will be enrolled sequentially and randomly allocated (1:1) to undergo honey treatment or usual care with normal saline using a “digital sealed envelope” method. An allocation table will be generated remotely by the trial statistician at The University of Birmingham to allocate participants in a 1:1 ratio at the level of the individual over the course of the trial. A random number generator will be used to generate a random sequence of the numbers between 1 to N inclusive. A permuted block randomisation method will be used by randomly selecting blocks of size 2, 4, 6, or 8 in order to maintain balance between the numbers allocated to each of the two groups. The generated table will be uploaded into the REDCap software to be used for participant enrolment. Access to the allocation table will be restricted. Trial staff in Nigeria will not have access to the allocation table. When a participant’s details are submitted, the trial arm and a unique study number will be assigned and revealed to the local clinician so that the randomised group that the participant is assigned to cannot be altered. Participants will be randomised to receive wound dressing treatment with honey twice a week or a normal saline dressing twice a week (control group). The treatment will be applied at the time of twice weekly changes of dressings by local trained nurses or paramedics. These dressing changes are part of routine care and will thus apply to the intervention and control groups. There is no pain from the procedure but dressing changes may take slightly longer for participants in the intervention group. Participants in both groups have twice-weekly dressing changes during their hospital stay until ulcers are healed. Any missed sessions will be noted but this will not be treated as a protocol deviation. |
| Intervention type | Other |
| Primary outcome measure | Assessed from ‘blindly’ examined photographs: 1. Rate of healing based on one observation per week until the ulcers are healed 2. Time to complete re-epithelisation (up to 84 days) |
| Secondary outcome measures | Long-term (6-month) end-points, measured using a physical examination of the treatment site: 1. Recurrence of treated ulcer 2. Appearance of a new ulcer 3. Anatomical changes in the limb Long-term endpoints will be measured using medical records at the time of follow up at 6 months from randomisation: 1. Days hospitalised prior to discharge and total (to include any readmission related to leprosy ulcers) by 6 months 2. Number of visits to any healthcare facility from discharge to the end of follow-up at 6 months |
| Overall study start date | 29/08/2021 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 130 |
| Total final enrolment | 130 |
| Key inclusion criteria | 1. Patients with a chronic foot ulcer of at least 6 weeks duration due to leprosy neuropathy 2. ≥18 years of age 3. Ulcer surface area between 2 and 20 cm² inclusive 4. Ulcer is clean, dry, and free from infection 5. Patient can provide informed consent |
| Key exclusion criteria | Patients will be excluded if: 1. Ulcer is less than 6 weeks from appearance 2. Less than 18 years of age 3. Ulcer surface area is less than 2 cm² or more than 20 cm² 4. Ulcer is infected or a diabetic foot ulcer 5. Patient declined to give consent |
| Date of first enrolment | 15/02/2022 |
| Date of final enrolment | 30/06/2024 |
Locations
Countries of recruitment
- Nigeria
Study participating centres
Minna
Niger State
Minna
-
Nigeria
-
Nigeria
Sponsor information
Charity
14/16 Kings Drive
Fort Royal Homes Estate
Lugbe
Abuja
000
Nigeria
| Phone | +234 (0)8117918420 |
|---|---|
| office@tlmnigeria.org | |
| Website | https://www.leprosymissionnig.org |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. Publication of the protocol is also planned. |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 0.6 | 06/10/2021 | 17/11/2021 | No | No |
| Protocol file | version 0.9 | 02/12/2022 | 04/01/2023 | No | No |
Additional files
Editorial Notes
31/12/2024: The total final enrolment was added.
04/01/2024: The following changes were made to the trial record:
1. The ethics approval (2) was added.
2. The study website was added.
3. The recruitment end date was changed from 30/01/2024 to 30/06/2024.
04/01/2023: The following changes have been made:
1. The recruitment end date has been changed from 30/01/2023 to 30/01/2024.
2. The overall trial end date has been changed from 31/12/2023 to 31/12/2024 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 31/12/2023 to 31/12/2024.
4. An updated protocol has been uploaded.
5. The study design has been updated to reflect that the study is conducted in more than one centre and is therefore no longer a single-centre study.
6. St Benedict’s TBL and Rehabilitation Hospital has been added to the trial participating centres.
01/02/2022: The recruitment start date was changed from 05/01/2022 to 15/02/2022.
17/11/2021: Trial's existence confirmed by the Niger State Government Ministry of Health Research Ethics Committee.
