Recurring leprosy ulcers Infections and Infestations Leprosy [Hansen disease]
Conditions
Interventions
Clusters will be constituted by villages local to either Mile Four or St Benedict’s Hospital. All of the clusters will receive the intervention by the end of the study, as a complete rollout is requir
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: People with a high risk of leprosy ulcer will be invited to enter the study and those who consent will contribute baseline data as stated above. People will be eligible if they have a risk of limb ulceration based on one or more of the following: 1. Current ulcer 2. Previous ulcer 3. Sensory loss in one or more extremities People will be recruited at baseline before their group is allocated to the intervention phase, to avoid any interaction between intervention status and participation. The researchers will follow all patients in each cluster as a cohort (to capture individual-level effects and provide more statistical power).
Exclusion criteria
Exclusion criteria: Does not meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The two-primary ulcer-related outcomes are: 1. The number of ulcers 2. The area of the largest ulcer on the hands/feet (cm²) The limbs will be inspected and their condition described using a standard form with information on anaesthesia, ulcers and any deformities using the World Health Organisation (WHO) disability grading system. Any ulcers will be noted and described on a form, resident on the electronic tablet. The clinical appearance of the wound (e.g. any residual exudate) will be recorded. The largest ulcer will be photographed in a standard manner for independent analysis blind to ‘treatment’ status. In addition, photographs of the plantar surfaces of the two feet together will also be taken from all participants. Ulcer metrics will be based on photographs taken during dressing changes in a standardised manner, as recommended in the literature. The photographs will be obtained by the research fellow using the camera in the data collection tablet and metrics obtained using the Electronic Pressure Ulcer Scale for Healing (PUSH) tool version 3.0. The PUSH tool enables measurement of the surface area (cm²) of the lesion calibrated from a plastic ruler, cleaned in spirit, placed in the photograph frame at the level of the ulcer. Measured at: Baseline Collection 1: Timepoint 1 Baseline Collection 2: 3 months after baseline 1 Post-Intervention 1: 3 months after 6-week intervention completion Post-Intervention 2: 3 months after the post-intervention 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life measured using EQ-5D-3L at Baseline Collection 1: Timepoint 1, Baseline Collection 2: 3 months after baseline 1, Post-Intervention 1: 3 months after 6-week intervention completion, and Post-Intervention 2: 3 months after the post-intervention 1 | — |
Countries
Nigeria
Contacts
Public ContactAnthony Meka
Outcome results
None listed