The Leprosy Mission Research Magazine - February 2022

Around 1 in 5 leprosy patients will experience a foot ulcer. Half of the in-patients in TLM’s hospitals are there for foot ulcer care. Sadly, even with...

TLM's Research Magazine

Issue 3: February2022

A common-sense and affordable answer to one of leprosy’s most common and painful problems

Around 1 in 5 leprosy patients will experience a foot ulcer. Half of the in-patients in TLM’s hospitals are there for foot ulcer care. Sadly, even with good self-care, foot ulcers are still inevitable for many patients. Even worse, if you experience one foot ulcer, there is a good chance you will experience another because you are putting all your body’s weight on the good foot, thus making it prone to ulcers. The existing established treatments for foot ulcers are not adequate and alternatives must be proven to be effective.

Using Leprosy Research Initiative (LRI) funding, TLM Trust India are setting about proving that a common sense and cost-effective foot ulcer treatment could be around the corner. This would be big news for the millions of people who will experience foot ulcers in the years to come.

Receiving foot ulcer treatment is not simple at this moment in time

Put yourself into the shoes of a person who has an ulcer on their foot. You will have developed this ulcer because you did not receive your leprosy diagnosis and treatment in time to prevent nerve damage leading to loss of feeling in your foot.

Before this nerve damage happened, you would have noticed and felt pain if you were walking with a small stone in your shoe. You would have noticed if you had stepped on something sharp. You would have noticed if the ground you were walking on was too hot from the sun.

Now, because you couldn't feel the damage the stone in your shoe was causing on your long walk home from work, you have a bad wound on the sole of your foot. No amount of cleaning the wound and taking care of it seems to be helping it to heal. It doesn’t hurt, but you know it needs to be fixed or it could become infected and your leg may need amputating. So, you set out for the hospital.

The team at the hospital tell you that you need to keep pressure off the ulcer so that it can heal. You are lucky because you are at a hospital where there is someone skilled enough to put a plaster cast on your leg - a difficult task, apparently. The plaster cast has a small hole where the ulcer is, which allows you to change the dressing. The plaster cast allows you to walk without putting pressure on the ulcer, which in turn will allow the ulcer to heal. You have to keep this cast on your leg for at least four to six weeks, sometimes more. The cast can only come off by breaking it, so you can’t take it off at all in that time.

In most cases, ulcers that are managed with plaster casts are managed at hospital as in-patients and in some cases, the hospital sends you home and tells you to come back at the end of the six weeks, or when ulcer heals, to have the cast removed. This is when the real problems start. First, you discover that the cast is very itchy when you are travelling in the hot, humid air outside. When you get home, you realise that you cannot pull trousers over the top of the cast. You have to cut the leg off one of your few pairs. Then, you try to ignore the constant itch under the cast as you lie awake at night.

The next morning you go to have a wash, but that proves very difficult with a cast covering one of your legs. You have no way to keep the cast dry through this process and you are very worried about dirty water getting caught inside the cast and causing an infection. After the stress of the wash, you go about your day, still trying to ignore the urge to itch. Around midday, the itching becomes much worse and you look down to find ants crawling on the floor by your feet. You are sure that some ants are now inside your cast, causing chaos.

The itching is unbearable and your fear of an infection inside the cast has just shot up. You have no way of putting a soothing ointment or antiseptic on. On day one of life with your new cast, you begin to wonder how you’ll get through the next six weeks.

The above is the current gold standard for treating foot ulcers.

TLMTI are taking the positives and solving the negatives

Led by Mr Karthikeyan (Karthik), TLMTI will be using funding from the Leprosy Research Initiative to develop an alternative to treating foot ulcers with a plaster cast.

Karthik tells us, “The plaster cast treatment has been proven to be effective; keeping pressure off the ulcer does allow it to heal. The problem is that plaster casts are very impractical.

“First, you do need a skilled technician to apply the plaster cast. Even if you are lucky enough to have such a technician at your hospital, the patients will still encounter many problems with the cast. We have some patients return to us in tears, long before the ulcer heals. They beg us to take the cast off so they can have some relief.”

The problem with the plaster casts are significant for the patient, but there is an alternative available, as Karthik explains,

"This project is affordable and common sense"

“Most of the problems with the cast happen because the cast cannot be removed. For some time, people have been exploring alternative casts that could be removed. This includes using a removable walker cast, the kind that is cheap and readily available and can even be bought on Amazon for around £25-35.

“However, we currently have no scientifically-proven evidence that this removable walker cast is as effective as the plaster cast. Until we prove that, we cannot make the, removable walker cast a standard part of ulcer treatment across the world.”

If it can be proven to be effective, the removable walker cast would solve a lot of problems

A patient can remove the walker cast to wash, to apply a soothing ointment, or to get rid of a pesky ant. They can also fit a pair of trousers over it. Like with the plaster cast, a rubber sole can be placed inside, with a part cut out, so the pressure will be kept off the ulcer to give it space to heal.

This should make the process far less upsetting for patients and will increase the likelihood that they will keep the cast on throughout the four-six week treatment period or until ulcer heals.

© Tom Bradley

Another advantage of the removable walker cast is the simplicity for the medical staff. The plaster cast requires a lot of skill to apply and not many people can do it. As well as this, the plaster can take as long as two or three days to set in the colder, winter seasons. Meanwhile, in humid countries, the cast is almost impossible to apply during the more humid months. The removable walker cast is far simpler for a healthcare worker to apply and can be used all year round.

“Our aim with this research project is not to prove that the plastic, removable walker cast is better at healing ulcers. Our aim is to prove that it is at least as good as the current gold standard, the plaster cast. This is known as a non-inferiority trial.

“The primary outcome we are looking at is the number of ulcers healed within a six-week period and the size of the ulcer area after that period. Is the ulcer reducing and how long did it take to heal? This is what will help us to prove that plastic casts work at least as well as plaster casts.

“The secondary outcomes for this project are what can separate the plastic cast from the plaster cast. Here we are looking at patient satisfaction. We want to know how independent patients are with the cast – can they dress, clean, walk, and take care of themselves? What is their quality of life?

“We will also follow up with patients over a six-month period to find out if they have experienced recurrences. We are hopeful that the removable walker cast will promote better healing, which will lead to a better scar that will help to prevent ulcers in the same place in the future.”

The trial should produce results in around two years

The trial is a randomised control trial, taking place at two of TLMTI’s hospitals. The team are hoping to recruit 150 patients to the trial, who will be split evenly between the test group and the control group. The control group will receive the plaster cast and the test group will receive the removable walker cast.

The team hope to start the project in April next year and they expect recruitment to take around 15 months. With the six-month follow-up period, this should mean that results will be ready for publication in about 24 months.

This project is affordable and common sense

With a total budget of just 44,000 euros, this project is an excitingly cost-effective and common sense treatment. Not only is the research project cost-effective, the long-term treatment options will be, as well. When they are cleaned and sanitised properly, the very affordable plastic casts will also be reusable for different patients.

If this project is successful, it will provide a treatment that could significantly improve quality of life for patients, it will be effective at all times of the year, it will be cheap, it will be simple for clinicians, and it could prevent ulcer recurrence. It is a project that we can be very glad to see getting started.

Mr Karthikeyan Govindasamy (research Coordinator)

Could you fund a researcher's salary?

The Leprosy Mission are currently offering the chance for you to contribute directly to our ground-breaking research.

Through our online shop you can buy a gift for life that will fund a month's salary for one of our researchers in India.

Contribute now

Healthcare workers display a lot of leprosy stigma. How can we change that?

“I do think that I did pick up some kind of cue about this disease not being an ‘open disease’ from all of the non-verbal communications happening around me… Firstly, with the doctor who diagnosed me. He did not look into my eyes and he did not talk to me in a way that I’m normally used to being talked to.

“Somewhere the stigma exists among the medical fraternity, for sure. I have enough stories that I’ve heard that show it does exist. There might be a cue given to the patient [from the healthcare professional] that says ‘you’re no longer touchable’.”

Jayashree recognises the stigma she experienced from a healthcare worker

These are the reflections of Jayashree, a person affected by leprosy in India. Her experience and the stories she has heard from others are not limited to any one place, they are sadly present across the world. There is a problem with leprosy-related stigma amongst healthcare workers.

It is this issue that Yohanna Abdou from TLM Niger is looking to address. He wants to know to what extent does improving the knowledge of healthcare workers reduce their stigmatising behaviour towards leprosy patients in health services of endemic areas in Niger.

Of course, healthcare workers' stigmatising attitudes towards leprosy mirror that of the larger society’s, and whilst there has been plenty of research into leprosy stigma, there has been little research into stigma that is specific to the healthcare sector. Yohanna must address that gap before finding solutions.

Using funding from the Leprosy Research Initiative, Yohanna is looking at what is driving this stigma among healthcare workers in Niger and how this stigma manifests itself. Once he has determined this, he intends to use education and awareness efforts that will be co-designed and co-implemented by persons affected by leprosy to tackle the stigma surrounding leprosy among healthcare workers in Niger.

The project is being operated in partnership with IDEA Niger, the Niger Leprosy Control Programme, and the University Abdou Moumouni Niamey.

Yohanna must determine what is behind the stigma and what the stigma looks like

Using the WHO Stigma Framework, Yohanna is going to identify the local and contextual drivers, facilitators, and manifestations of stigma among healthcare workers. As well as this, he is hoping to determine the effect that this stigma is having on persons affected by leprosy in Niger.

This will be made possible by conducting in-depth group and individual interviews with healthcare workers from each of the 16 participating health centres in Niger. By the end of this phase of the project, Yohanna will have interviewed a minimum of 40 healthcare workers.

As well as this, Yohanna will conduct group interviews with 80 persons affected by leprosy to explore their experiences of stigma and discrimination in the healthcare setting.

Yohanna and his team believe that much of the stigma may derive from fears of infection, social judgement, and learnt habits and beliefs that have been developed through cultural norms, but these working theories can only be confirmed, amended, or corrected through the interview stage of this research project.

Once the data has been collected from the interview process, Yohanna and the team will produce a report on what is driving leprosy stigma in the healthcare context and how this stigma manifests.

Using his findings, Yohanna will work with persons affected by leprosy to tackle the stigma

The second stage of the project requires Yohanna and the team to work on solutions to the problems that they have identified.

Although there is no substantial research into leprosy stigma among healthcare workers, there has been research into HIV stigma amongst healthcare workers and how that stigma can be tackled.

Yohanna will use the findings from their research and the tools that have been developed to tackle HIV stigma to develop new tools to tackle leprosy stigma among healthcare workers. They will work with persons affected by leprosy to analyse the findings and develop the tools.

They will develop educational tools together that will initially be trialled with 10 healthcare workers. Their intention is that these tools will be both co-developed and co-delivered by persons affected by leprosy.

The impact of these tools will be monitored into the future

Six months after healthcare workers have engaged with the educational tools that Yohanna and the team developed, the team will return to the healthcare workers.

At this point, the healthcare workers’ leprosy knowledge will be tested and scored and the team will consider issues like the desired social distance a healthcare worker wants from a person affected by leprosy.

They will conduct focus group interviews with healthcare workers to explore their experiences of the training and its impact on their behaviours and attitudes.

Importantly, the team will also talk to persons affected by leprosy about their experiences of the care they have received since the training and to identify any changes in the healthcare workers.

The role of persons affected by leprosy will be central throughout the project

Yohanna has made persons affected by leprosy central to this project.

“For me, the presence of persons affected by leprosy throughout our work is what gives us the best chance of success. IDEA Niger have been involved since the very conception of this project and will be involved right to the end.

“Ultimately, this project is about their experiences. That means we can only define the problem through their knowledge and experience and we can only determine the success of the solutions through them. In between those things, we need their continued input to develop and implement our approach to tackling stigma.”

The project started at the beginning of 2022 and will run for 42 months, after which Yohanna and the team hope to have new insights and tools that will allow us to tackle leprosy stigma in healthcare contexts across the world.

Front cover photo credit: Ricardo Franco

Yohanna Abdou, TLM Niger

Making self-care guidelines that work for the people that use them

In December, the Leprosy Review produced an issue dedicated to self-care. Within this issue were new self-care guidelines. These guidelines aim to improve the uptake of self-care amongst people with leprosy ulcers.

The Leprosy Mission Trust India are taking these guidelines one step further by working alongside persons affected by leprosy to learn how these guidelines will work best within their lives and their communities.

They will work with patients on co-developing a version of the guidelines that will be specific to the communities they are working with.

In this video, Dr Joydeepa Darlong of The Leprosy Mission Trust India talks about how their project will work, what it hopes to achieve, and what co-production of these resources will look like.

Above, Dr Joydeepa explains TLMTI's self-care guidelines project

Dr Joydeepa Darlong

How do we prepare countries for PEP?

PEP stands for post-exposure prophylaxis. It is the term for a medicine that is provided after a person has been exposed to a disease but does not yet have symptoms. The intention is that this medicine will prevent the person from developing the disease.

To prevent leprosy through PEP, healthcare workers prescribe rifampicin, one of the three antibiotics that make up Multi-Drug Therapy. PEP has become crucial to the global fight to defeat leprosy and is now a central part of the WHO’s Global Leprosy Strategy 2021-2030. Alongside contact tracing and active case finding, PEP is the key to ending the transmission of leprosy.

However, in leprosy’s 4,000-year history, the discovery of PEP and the evidence base for its efficacy is very recent. Research teams are still working to establish the perfect dose for PEP and many country programmes are not yet ready for PEP.

In order to ensure a full, effective, and long-term roll out of PEP, nations must first trial PEP within their own contexts. That is exactly what is happening through Nigeria’s Ready4PEP programme, which is happening in collaboration with NLR and the Leprosy and Tuberculosis Relief Initiative (LTR). Here’s how it works.

©Ala Kheir

Step 1: Determine the scope of the trial

Dr Saminu Msheliza is managing TLM Nigeria’s Ready4PEP programme. He tells us that the initial pilot of PEP in Nigeria is taking place in six Nigerian states where they will be tracing contacts of newly diagnosed leprosy cases and providing them with a single dose of rifampicin.
PEP has already been established as part of Nigeria’s National Leprosy Control Programme Guidelines, so the government has been working closely with TLM Nigeria to enable the READY4PEP project.

Their aim is to answer one simple question: does providing a single dose of rifampicin to the contacts of newly diagnosed leprosy cases reduce the number of people who develop leprosy. Even simpler, does PEP work in Nigeria?

The team knows the number of leprosy cases that have been diagnosed in the six participating states over the last three years. If that number drops significantly during the pilot period (2021-2023), then this is a strong indication that PEP does work in Nigeria.

Step 2: Recruit local healthcare workers to the programme

In each of the six states that are running the READY4PEP project, TLM Nigeria is working in four local government areas - two local governments each in two states of the six. The local governments’ healthcare workers have received training in conducting contact tracing, screening contacts, and providing PEP to close contacts who do not have symptoms of leprosy. The local healthcare workers will trace the contacts of 100 percent of new leprosy cases within their districts throughout the pilot.

They have also been instructed to keep close records of what they are finding, which are shared with TLM Nigeria, as Dr Saminu tells us,

“We will collect data on the number of people who receive PEP and the number of new cases we identify through the screening of contacts. We will continue to follow up with PEP recipients until 2023, having started the programme in July 2021. We will determine how many of the PEP recipients have gone on to develop leprosy. So far, we are pleased to say that none of the PEP recipients has gone on to develop leprosy.”

Step 3: Analysing the data

The TLM Nigeria team will share the data they collect with NLR via LTR, who have substantial experience with PEP. NLR, working with academics in the Netherlands, will analyse the data provided to determine the efficacy of PEP in Nigeria.

They will compare the data to the previous three years of cases in the six participating states and will compare the trends they are seeing in these pilot states with the trends across Nigeria more broadly and with the data from past PEP projects.

“On average, PEP reduces the chance of developing leprosy by almost 60 percent among close contacts, so we are hopeful that we will see similar trends. This prospect has proved very exciting in Nigeria, with the government and persons affected by leprosy expressing a real interest in what we are doing.”

Step 4: Learning from the process

PEP roll out is different in every country, so there will be a lot to learn from this pilot about how PEP works in the Nigerian context, as Dr Saminu explains,

“We have already seen how PEP is different from what we were expecting. We had thought that we would be providing around 15 people with PEP for each newly diagnosed person. However, in communities in Niger State and Kebbi State, we have been providing closer to 50 people with PEP for each newly diagnosed case. Already we have learnt that we need to adjust our stockpile of rifampicin accordingly.

“Our project is also different from other PEP projects because we have trained local healers, pharmacists, and traditional healers to recognise leprosy. We have set up referral pathways so that they can direct people with suspected leprosy symptoms to a healthcare professional who can provide them with treatment and begin the contact tracing process. At the end of the project, we will be keen to establish whether these referral pathways worked.”

Step 5: Rolling out PEP nationally

“When we have established the efficacy of PEP in Nigeria and have conducted a review of how the experience of the pilot was different in Nigeria when compared to other pilots, we will be ready to roll this out across the whole country. The government is waiting on the outcome of READY4PEP before they take PEP national.

“There is real excitement within Nigeria about the potential of PEP. We are hopeful that it can be the pathway through which we can achieve leprosy elimination. Of course, we will continue to track the progress of PEP within Nigeria to be sure that it is remaining effective.”

Dr. Saminu Msheliza

Will you support TLM's lab in Nepal?

Right now, Anandaban's research lab is at risk of closing. It is too small and was severely damaged in the disastrous earthquakes of 2015. The lab simply won’t pass the upcoming Nepali Government inspection.

The Leprosy Mission is currently raising funds for a rebuild project, so our researchers can stay on track towards a world without leprosy.