Improving the management of leprosy ulcers through a community self-care (EARLY) intervention

ISRCTN	ISRCTN12572449
DOI	https://doi.org/10.1186/ISRCTN12572449
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	NIHR200132
Sponsor	University of Birmingham
Funder	National Institute for Health and Care Research

Submission date: 09/08/2022
Registration date: 18/08/2022
Last edited: 14/09/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
In low- and middle-income countries (LMICs), there are diseases that tend to affect the poorest of poor people. Leprosy is one such disease. Antibiotics can kill the bacteria that cause disease in the first place, but that is not the end of the story. In the case of leprosy, local nerve damage leads to repeated injury and hence recurring and disfiguring ulcers. Patients (and their families) face stigma, social isolation and catastrophic costs. This study aims to improve self-care in the community for patients who are at risk of recurring leprosy ulcers. This project will be based in South Eastern Nigeria and will be managed by the German Leprosy and Tuberculosis Relief Association in Enugu.

Who can participate?
The study will be conducted in clusters made up of villages local to either Mile Four or St. Benedict’s hospital. Leprosy-affected individuals living in the clusters can participate if they have an existing ulcer, they had an ulcer, or if they suffer from loss of sensation in their limbs.

What does the study involve?
The study involves the creation of self-care groups which will provide education to group members on conducting self-care activities.

What are the possible benefits and risks of participating?
There are no known side effects to the practice of self-care. All previous research points to self-care having a beneficial effect. Participants will benefit from the tailored education on performing self-care and from the social support available through the newly formed groups.

Where is the study run from?
The study is conducted by the German Leprosy and TB Relief Association in Enugu, Nigeria with support and supervision from the University of Birmingham (UK)

When is the study starting and how long is it expected to run for?
July 2020 to November 2024

Who is funding the study?
National Institute for Health Research (NIHR) Research and Innovation for Global Health Transformation (RIGHT) Programme (UK)

Who is the main contact?
1. Prof. Richard Lilford, R.J.LILFORD@bham.ac.uk
2. Dr Anthony Meka, anthony.meka@dahw.org

Contact information

Prof Richard Lilford
Principal investigator

Room 108, First Floor
Murray Learning Centre
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom

Phone	+44 (0)121 414 6772
Email	R.J.LILFORD@bham.ac.uk

Dr Onaedo Ilozumba
Scientific

Room 117, Murray Learning Centre
Birmingham
B13 9WZ
United Kingdom

Phone	+44 (0)7404187819
Email	u.ilozumba@bham.ac.uk

Dr Anthony Meka
Public

56 Nza St, Independence Layout
Enugu
400001
Nigeria

Phone	+234 (0)803 702 8796
Email	anthony.meka@dahw.org

Study information

Primary study design	Interventional
Study design	Incomplete stepped-wedge cluster randomized trial
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	ImplementatioN Science sTudy In Leprosy: Improving the management of leprosy ulcers through a community self-care intervention using a stepped wedge cluster randomised trial
Study acronym	INSTIL Nigeria
Study objectives	It is hypothesised that following the intervention, ulcers will form less often and that, when they do form, they will be smaller and less likely to progress to the point where hospital treatment is required. It is hypothesised that the intervention will be associated with improved quality of life and welfare among all people in the self-care groups.
Ethics approval(s)	Approved 27/08/2020, University of Nigeria Teaching Hospital (Ituku Ozalla P.M.B 01129, Enugu, Nigeria; +234 (0)42 252 022; cmduth2019@gmail.com), ref: UNTH/CSA/329/VOL5/08
Health condition(s) or problem(s) studied	Recurring leprosy ulcers
Intervention	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 required so that the central hospital can provide a consistent level of care. Furthermore, as the interventions cannot be delivered in parallel their implementation will be staggered over time. The researchers will include all ten clusters in Abakaliki (Mile Four Hospital) and all five in Ogoja (St. Benedict’s Hospital). The order of implementation and observation will be randomised with the hospital catchment area. A random number will be generated for each cluster and the order determined by the ascending value of the random numbers. 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). The ‘active’ phase of intervention will involve 10 days of on-site outreach activity from the ‘intervention team’ over a one-month period. In the ‘sustainability’ phase, outreach will be reduced to about 1 day per 6 weeks. The self-care intervention will be delivered face-to-face in a group setting. Self-care training is based on the ISSOD-F, a routine series of steps namely Inspection, Soaking, Scraping, Oiling, Dressing and Footwear. The training will be delivered by group facilitators to group members.
Intervention type	Behavioural
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	01/11/2024

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	90
Key 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).
Key exclusion criteria	Does not meet the inclusion criteria
Date of first enrolment	01/04/2021
Date of final enrolment	31/05/2023

Locations

Countries of recruitment

Nigeria

Study participating centre

German Leprosy and Tuberculosis Relief Association

56 Nza St, Independence Layout
Enugu
400001
Nigeria

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	Non-identifiable cluster and individual level data will be available on request after trial completion. All anonymized data demographic data and completed surveys (EQ-5D-3L and A life satisfaction) would be available for use. Data will be made available 6 months after the completion of the trial (June 2025) and will be available for 5 years. Data will be shared after the assessment of a detailed proposal by the Chief Investigator Prof. Richard Lilford (R.J.LILFORD@bham.ac.uk). Data will be shared with researchers affiliated with academic institutions, non-governmental agencies and governmental agencies. The analyses will be proposed by the researcher requesting the data, it cannot have require identifying information of study participants. Data will be shared via an agreed-upon secure channel that is accessible to both the trial research team and the researcher requesting the data.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

14/09/2022: The public title was changed from 'Transforming the treatment and prevention of leprosy and Buruli ulcers in low- and middle-income countries' to 'Improving the management of leprosy ulcers through a community self-care (EARLY) intervention'.
15/08/2022: Trial's existence confirmed by the University of Nigeria Teaching Hospital.