Leprosy ulcer Infections and Infestations Leprosy [Hansen disease]
Conditions
Interventions
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 b
Sponsors
The Leprosy Mission Nigeria
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Nigeria
Contacts
Public ContactPaul Tsaku
Outcome results
None listed